Zydus Lifesciences, a pharmaceutical company, has been instructed to revise a post-marketing surveillance (PMS) study for its Tofacitinib ER (extended-release) tablets. The company had submitted the study protocol to the regulatory authorities, but it appears that the submission did not meet the required standards.

Tofacitinib is a medication used to treat various inflammatory conditions, including rheumatoid arthritis, ulcerative colitis, and psoriatic arthritis. The extended-release formulation of the tablets allows for once-daily dosing, which can improve patient compliance. However, as with any new drug or formulation, regulatory authorities require thorough evaluation of its safety and efficacy in real-world settings through PMS studies.

The revision of the PMS study protocol is crucial for several reasons. Firstly, it ensures that the study design is robust enough to capture accurate and reliable data on the safety and efficacy of Tofacitinib ER tablets in a large and diverse patient population. Secondly, the revised protocol must address any concerns or gaps identified by the regulatory authorities, which could include issues related to patient selection, data collection methods, and analytical approaches.

The requirement for revision may also indicate that the initial protocol did not fully adhere to regulatory guidelines or did not provide sufficient detail on how the study would handle potential challenges, such as patient dropout rates or the management of adverse events. The regulatory authorities’ feedback is an essential part of the drug development and approval process, ensuring that pharmaceutical companies conduct rigorous and meaningful research to support the safe and effective use of their products.

In response to the regulatory feedback, Zydus Lifesciences will need to revise and resubmit the PMS study protocol. This process involves addressing the specific concerns and recommendations provided by the regulatory authorities, which could require adjustments to the study design, methodology, or even the inclusion and exclusion criteria for patients. Once the revised protocol is approved, the company can proceed with conducting the PMS study, which will provide critical insights into the real-world performance of Tofacitinib ER tablets.

The outcome of the PMS study will be significant, not only for Zydus Lifesciences but also for patients and healthcare providers. It will contribute valuable information to the body of evidence supporting the use of Tofacitinib ER tablets, helping to optimize treatment strategies and improve patient outcomes. Through this process, regulatory authorities ensure that pharmaceutical companies maintain high standards of research and drug development, ultimately protecting public health and advancing medical science.

Dr. Reddy’s and Zydus Lifesciences, two major Indian pharmaceutical companies, have initiated recalls of certain medicines in the US due to quality issues. The recalls were voluntarily undertaken by the companies by the US Food and Drug Administration (US FDA).

Dr. Reddy’s is recalling several lots of its Metformin Hydrochloride Extended-Release Tablets, which are used to treat type 2 diabetes, due to the detection of N-Nitrosodimethylamine (NDMA) impurities above the acceptable daily intake limit. NDMA is a known carcinogen and its presence in medications has been a major concern in recent years.

Zydus Lifesciences, on the other hand, is recalling certain lots of its Lisinopril Tablets, which are used to treat high blood pressure and heart failure. The recall was initiated due to the presence of an impurity called N-Methylnivaldipine, which is a known byproduct of the manufacturing process.

Both recalls are classified as Class II recalls, which means that the use of the affected products may cause temporary or medically reversible adverse health consequences. However, the FDA has stated that there is no immediate risk to patients who have taken the affected medications, and patients are advised to continue taking their medications as directed until they can obtain a replacement or alternative treatment.

The recalls are a result of the US FDA’s ongoing efforts to ensure the quality and safety of medications marketed in the US. The agency has been working closely with pharmaceutical companies to identify and address quality issues, including the presence of impurities in medications.

Dr. Reddy’s and Zydus Lifesciences have stated that they are committed to ensuring the quality and safety of their products and are cooperating fully with the US FDA to resolve the issues. The companies have also notified their distributors and retailers to stop further distribution of the affected products and to return any unused products to the company.

The recalls highlight the importance of quality control and monitoring in the pharmaceutical industry. Patients who have been taking the affected medications are advised to contact their healthcare provider or pharmacist for guidance on what to do next. The US FDA will continue to monitor the situation and take any necessary actions to ensure the safety and quality of medications marketed in the US.

Dr. Reddy’s Laboratories and Zydus Lifesciences, two major pharmaceutical companies, are recalling certain products in the US due to manufacturing issues. According to the US Food and Drug Administration (USFDA), Dr. Reddy’s Laboratories is recalling 571 vials of Succinylcholine Chloride Injection, which is used to relax muscles. The recall was initiated due to an “Out-of-Specification result during the six-month stability testing” of the product.

The recall, which was initiated on September 26, is classified as a Class II recall, meaning that the use of the product may lead to temporary or medically reversible health consequences. Dr. Reddy’s Laboratories has a subsidiary in Princeton, New Jersey, which is handling the recall.

Zydus Lifesciences is also recalling over 1,500 boxes of Entecavir tablets, an antiviral medication used to treat chronic hepatitis B virus. The recall was initiated due to “failed impurity/degradation specifications” and affects 912 and 600 bottles of the tablets in strengths of 0.5 mg and 1 mg, respectively. The recall, which was initiated on September 24, is also classified as a Class II recall.

The USFDA’s Enforcement Report stated that both recalls are nationwide and were initiated by the companies’ US-based arms. The recalls highlight the importance of maintaining high standards of quality and manufacturing in the pharmaceutical industry. India has the highest number of USFDA-compliant pharmaceutical plants outside of the US, and companies like Dr. Reddy’s Laboratories and Zydus Lifesciences must adhere to strict guidelines to ensure the safety and efficacy of their products.

The recalls are a precautionary measure to prevent any potential harm to patients, and the companies are taking steps to rectify the issues and prevent similar problems in the future. The USFDA’s classification of the recalls as Class II indicates that the risks associated with the products are minimal, but the companies are still taking proactive steps to address the issues and maintain patient safety.

The Appellate Authority for Advance Ruling (AAAR) in Ahmedabad, Gujarat, has upheld a ruling by the Gujarat Authority for Advance Ruling (GAAR) that subscription and redemption of mutual fund units constitute a sale transaction, subject to input tax credit (ITC) reversal. The appeal was filed by Zydus Lifesciences Ltd., a pharmaceutical company that had invested surplus funds in mutual fund schemes and subsequently redeemed them to maintain liquidity.

The company had availed ITC on common inputs and input services used for both taxable supplies and investment activities, but GAAR held that the value of mutual fund transactions must be treated as part of exempt supplies under Section 17(3) of the Central Goods and Services Tax Act, 2017. This meant that the company was required to reverse a proportionate amount of ITC.

The AAAR applied the “common parlance test” to determine that the redemption of mutual fund units amounts to a sale transaction. The bench observed that the law explicitly includes transactions in securities, such as mutual fund units, in the valuation of exempt supplies. The Central Goods and Services Tax Rules, 2017, prescribe that the value of securities shall be taken as one per cent of their sale value for the purpose of ITC reversal.

The AAAR rejected the company’s argument that no mechanism exists for computing the value of redemption for ITC reversal, stating that the rules provide a clear mechanism for computation. The authority also clarified that even if mutual fund investments are considered activities in the course of business, ITC reversal under Section 17(2) read with Section 17(3) remains compulsory.

The AAAR ruled that the company was liable to reverse proportionate ITC on common inputs and input services used in activities relating to the subscription and redemption of mutual fund units. The appeal was dismissed, and the GAAR’s decision was upheld. The ruling has significant implications for businesses that invest in mutual funds and claim ITC on related inputs and services.

The decision is based on the interpretation of Section 17(3) of the Central Goods and Services Tax Act, 2017, which includes transactions in securities within the computation of exempt supplies. The AAAR’s ruling provides clarity on the treatment of mutual fund transactions under the GST law and emphasizes the need for businesses to reverse ITC on related inputs and services. The ruling is expected to have a significant impact on the pharmaceutical and financial services industries, where mutual fund investments are common.

Zydus, a leading Indian pharmaceutical company, has received approval from the US Food and Drug Administration (USFDA) for a new drug. This approval is a significant milestone for the company, as it demonstrates its ability to develop and manufacture high-quality medicines that meet the stringent regulatory requirements of the US market.

The approved drug is a generic version of a medication that is used to treat a specific condition. Zydus has developed this drug through its own research and development efforts, and the USFDA approval is a testament to the company’s capabilities in this area.

The approval of this new drug by the USFDA is expected to have a positive impact on Zydus’ business, as it will allow the company to expand its product offerings in the US market. The US is one of the largest pharmaceutical markets in the world, and having a presence in this market is crucial for any pharmaceutical company that wants to be a major player globally.

Zydus has been investing heavily in its research and development capabilities, and this approval is a reflection of the company’s commitment to innovation and quality. The company has a strong pipeline of products in development, and it is expected to launch several new drugs in the coming years.

The USFDA approval is also a significant achievement for Zydus’ manufacturing facilities, which have been inspected and approved by the US regulatory agency. The company’s manufacturing facilities are equipped with state-of-the-art technology and follow strict quality control procedures, ensuring that the products manufactured are of the highest quality.

The approval of this new drug by the USFDA is a major milestone for Zydus, and it demonstrates the company’s ability to develop and manufacture high-quality medicines that meet the stringent regulatory requirements of the US market. With this approval, Zydus is well-positioned to expand its presence in the US market and become a major player in the global pharmaceutical industry.

This approval is also expected to have a positive impact on the company’s revenue and profitability, as the US market is a significant contributor to the company’s top line. Zydus is expected to launch the approved drug in the US market soon, and it is expected to be a major contributor to the company’s revenue growth in the coming years. Overall, the USFDA approval is a significant achievement for Zydus, and it demonstrates the company’s commitment to innovation, quality, and regulatory compliance.

The US Food and Drug Administration (FDA) has rejected the New Drug Application (NDA) for CUTX-101, a treatment for Menkes disease, developed by Fortress Biotech and Zydus Technologies. The FDA’s decision was based on concerns regarding Good Manufacturing Practice (GMP) at the manufacturing facility. Menkes disease is a rare genetic disorder that affects copper levels in the body, leading to severe neurological and physical symptoms. CUTX-101, a copper histidinate injection, had received Fast Track and Rare Pediatric Disease designations from the FDA. The rejection is a significant setback for the companies, which will need to address the GMP concerns before resubmitting the application.

In other news, Jazz Pharmaceuticals has received expanded FDA approval for its lung cancer combination treatment, Zepzelca (lurbinectedin). The approval is for the treatment of adult patients with small cell lung cancer (SCLC) who have received one or more prior lines of therapy, including patients with disease progression on or after platinum-based chemotherapy. Zepzelca is now approved for use as a single agent, and the expanded label includes data from the Phase 3 trial, which demonstrated improved overall survival and progression-free survival compared to topotecan. The approval marks an important milestone for Jazz, which acquired the rights to Zepzelca from PharmaMar in 2019.

The FDA’s decision to reject CUTX-101 highlights the importance of GMP compliance in the pharmaceutical industry. Manufacturers must ensure that their facilities meet strict standards for quality, safety, and efficacy to guarantee the integrity of their products. The rejection of CUTX-101 will likely delay the availability of this much-needed treatment for Menkes disease patients. On the other hand, the expanded approval of Zepzelca provides new hope for patients with SCLC, who have limited treatment options. Jazz Pharmaceuticals’ investment in Zepzelca has paid off, and the company is now well-positioned to capitalize on the growing demand for lung cancer treatments.

The regulatory landscape for pharmaceuticals is constantly evolving, with the FDA playing a critical role in ensuring the safety and efficacy of new treatments. As companies navigate the complex and often challenging regulatory process, they must be prepared to address concerns and adapt to changing requirements. In this context, the FDA’s rejection of CUTX-101 and approval of Zepzelca serve as reminders of the importance of rigorous testing, quality manufacturing, and robust clinical data in bringing new treatments to market.

Zydus Lifesciences Ltd., a global innovation-led healthcare company, has announced its collaboration with Pinkathon, India’s largest women’s run, to raise awareness about breast cancer and women’s health. The 10th edition of the Mumbai Pinkathon, scheduled for December 21st, 2025, will be the first of six events across India, covering cities such as Bengaluru, Delhi, Hyderabad, Kolkata, and Chennai. The run, led by women, aims to encourage women to prioritize their health, with a focus on regular self-breast exams and early detection of breast cancer.

The event was unveiled by Dr. Sharvil Patel, Managing Director of Zydus Lifesciences, Meha Patel, Vice-Chairperson of Zydus Foundation, actor and fitness icon Milind Soman, and Ankita Konwar, Founder of Invincible Women. They emphasized the importance of regular self-breast exams, highlighting that a simple 3-minute exam can make a life-saving difference. Dr. Sharvil Patel stated that the “Easiest Exam” campaign, launched by Zydus, aims to empower women with knowledge and inspire collective action against breast cancer.

Milind Soman, founder of Pinkathon, emphasized the mission to encourage women to take charge of their health and fitness, while building a community that celebrates strength and inclusivity. Meha Patel, Vice-Chairperson of Zydus Foundation, highlighted the importance of women prioritizing their health, stating that a healthy woman is at the core of a happy and well-functioning family.

The Mumbai edition of Zydus Pinkathon will feature various categories, including 3 km, 5 km, 10 km, and ultra-distances. Registrations are now open for all categories. The association between Zydus and Pinkathon will engage over 30,000 women nationwide, with the journey beginning in Mumbai and traveling to other cities over the next nine months.

Breast cancer is a significant concern in India, with over 2 lakh women diagnosed every year, and every 8 minutes, a woman dies due to late-stage diagnosis. Early detection is crucial, and Zydus’ campaign, “The Easiest Exam,” urges women to perform regular self-breast exams. The second edition of the campaign, scheduled to launch in October, will emphasize the importance of early detection and dispel myths and misconceptions associated with breast cancer. Through awareness campaigns, podcasts, and on-ground events, the initiative aims to address the stigma around breast cancer and inspire women to take control of their health.

Zydus, a pharmaceutical company, has partnered with Pinkathon, a women’s running event, to raise awareness about breast cancer across India. The initiative aims to educate women about the importance of early detection and prevention of breast cancer. As part of the collaboration, Zydus and Pinkathon will organize various activities, including workshops, seminars, and marathons, to promote breast health and encourage women to adopt a healthy lifestyle.

Breast cancer is one of the most common types of cancer affecting women in India, with over 1.5 lakh new cases being reported every year. The disease is often diagnosed at an advanced stage, resulting in poor treatment outcomes. However, with early detection and timely treatment, breast cancer can be cured. The partnership between Zydus and Pinkathon seeks to address this issue by promoting awareness and encouraging women to undergo regular check-ups and screenings.

The initiative will also focus on dispelling common myths and misconceptions surrounding breast cancer. Many women in India are hesitant to discuss breast health or undergo screenings due to social stigma and lack of awareness. Zydus and Pinkathon aim to change this by creating a supportive environment where women can openly discuss their health concerns and seek medical help when needed.

The partnership will also involve collaboration with healthcare professionals, NGOs, and community leaders to reach out to women in rural and urban areas. The initiative will provide training and resources to healthcare workers, enabling them to provide better care and support to breast cancer patients. Additionally, Zydus and Pinkathon will work together to develop educational materials and resources, such as brochures, videos, and mobile apps, to promote breast health and awareness.

Overall, the partnership between Zydus and Pinkathon has the potential to make a significant impact on breast cancer awareness and prevention in India. By working together, the two organizations can help reduce the burden of breast cancer and improve health outcomes for women across the country. The initiative serves as a reminder that collective efforts can lead to positive change and that every small step counts in the fight against breast cancer.

ZyVet Animal Health, a subsidiary of Zydus Pharmaceuticals, has introduced two FDA-approved generic medicines for animals in the US market. The first medicine, Phenylpropanolamine hydrochloride tablets, is used to treat urinary incontinence in dogs, a condition commonly affecting spayed females and older dogs. This medication works by addressing urethral sphincter hypotonus, a condition that leads to urinary incontinence. With this launch, veterinarians now have an affordable alternative for long-term management of the disorder.

The second medicine, Furosemide tablets, is used to manage congestive heart failure and chronic fluid retention in dogs and cats. Furosemide is a commonly prescribed diuretic that reduces edema and pulmonary congestion caused by cardiac, renal, or systemic disease. The approval of these generic medicines is expected to provide veterinarians with cost-effective treatment options for their patients.

The launch of these generic medicines comes as Zydus Lifesciences Ltd reported a net profit of ₹1,467 Crore for the quarter ended June 2025, a 3.3% increase from the previous corresponding period. The company’s revenue also registered a 6% year-over-year growth at ₹6,574 Crore, with an EBITDA of ₹2,089 Crore for the quarter.

The introduction of these generic medicines is a significant development for the animal health industry, as it provides veterinarians with affordable treatment options for common conditions affecting dogs and cats. The approval of these medicines by the FDA ensures their safety and efficacy, giving pet owners and veterinarians confidence in their use. With the growing demand for affordable and effective animal health treatments, ZyVet Animal Health’s launch of these generic medicines is a positive step forward for the industry.

Meha Patel, the Vice Chairperson of the Zydus Foundation, has been appointed as a member of the Confederation of Indian Industry (CII) National Committee on Art & Culture for the year 2025-26. This appointment is a significant recognition of Meha Patel’s contributions to the field of art and culture, and her expertise in promoting and preserving India’s rich cultural heritage.

The CII National Committee on Art & Culture is a prestigious platform that brings together industry leaders, artists, and cultural experts to promote and develop India’s art and culture sector. The committee’s objectives include promoting Indian art and culture globally, supporting the development of cultural infrastructure, and fostering collaborations between industry, government, and cultural institutions.

As a member of the CII National Committee on Art & Culture, Meha Patel will play a key role in shaping the committee’s policies and initiatives, and will work closely with other members to promote India’s art and culture sector. Her appointment is expected to bring a new perspective and energy to the committee, and will help to further the Zydus Foundation’s mission of promoting social and cultural development.

The Zydus Foundation is a non-profit organization that works towards promoting social and cultural development, and has been involved in various initiatives to promote art, culture, and education. Meha Patel’s appointment to the CII National Committee on Art & Culture is a testament to the foundation’s commitment to promoting India’s rich cultural heritage, and its efforts to make a positive impact on society.

Meha Patel’s appointment is also a recognition of her individual contributions to the field of art and culture. As a prominent social and cultural figure, she has been involved in various initiatives to promote Indian art and culture, and has worked tirelessly to support the development of cultural infrastructure in India. Her expertise and passion for art and culture make her an ideal candidate for the CII National Committee on Art & Culture, and her appointment is expected to be a significant asset to the committee.

Overall, Meha Patel’s appointment as a member of the CII National Committee on Art & Culture is a significant recognition of her contributions to the field of art and culture, and her expertise in promoting and preserving India’s rich cultural heritage. Her appointment is expected to bring a new perspective and energy to the committee, and will help to further the Zydus Foundation’s mission of promoting social and cultural development.

India’s outward foreign direct investment (FDI) has seen a significant decline in August, dropping to $2.1 billion from $3.4 billion in the same month last year. This represents a 38% decrease year-over-year. Compared to the previous month, the decline is even more pronounced, with a 49% drop from $4.1 billion in July.

The Reserve Bank of India (RBI) data reveals that the decline in outward FDI is attributed to a decrease in all three components: equity, loans, and guarantees. Equity investment fell to $939.6 million in August, down from $1.2 billion last year and $1.7 billion in July. Debt, or loans, also decreased to $510.3 million in August, compared to $682.1 million last year and $737.2 million in July.

Guarantees for overseas units saw the sharpest decline, moderating to $647.8 million in August from $1.5 billion last year and $1.64 billion in July. This represents a 57% decrease year-over-year and a 61% decrease compared to the previous month.

Despite the overall decline, some Indian companies continued to make significant investments abroad. Tata Steel committed $355 million in equity to its Singapore-based subsidiary, while Zydus Medtech invested $232.6 million in its French subsidiary, comprising $230.3 million in guarantees and $2.3 million in equity. Samvardhana Motherson International also invested $230.3 million in debt in a joint venture in the Netherlands.

The decline in India’s outward FDI may be indicative of a cautious approach by Indian companies in the face of global economic uncertainty. However, the continued investment by companies like Tata Steel, Zydus Medtech, and Samvardhana Motherson International suggests that Indian businesses remain committed to expanding their global presence. Overall, the data suggests that Indian companies are adopting a more measured approach to foreign investment, with a focus on strategic and targeted investments rather than broad-based expansion.

A Central Drugs Standard Control Organisation (CDSCO) panel has rejected Zydus’ request for a phase III clinical trial (CT) waiver for their proposed COVID-19 vaccine. The decision was based on the panel’s findings that the available data on the vaccine’s efficacy and safety were insufficient.

The CDSCO panel reviewed the company’s application, which included data from phase I and II trials, as well as animal studies. However, the panel felt that the data did not provide adequate evidence of the vaccine’s efficacy and safety in humans. Specifically, the panel noted that the phase II trial had a small sample size and was not adequately powered to determine the vaccine’s efficacy.

The panel also raised concerns about the vaccine’s safety profile, citing a lack of long-term follow-up data and inadequate reporting of adverse events. Additionally, the panel noted that the company had not provided sufficient data on the vaccine’s immunogenicity, which is the ability of the vaccine to induce an immune response.

The CDSCO panel’s decision is a setback for Zydus, which had hoped to accelerate the development of its COVID-19 vaccine. The company will now need to conduct a phase III clinical trial, which will require a larger sample size and more comprehensive data on the vaccine’s efficacy and safety.

The rejection of Zydus’ waiver request highlights the importance of rigorous clinical trials in ensuring the safety and efficacy of COVID-19 vaccines. The Indian government has been pushing for the rapid development of indigenous COVID-19 vaccines, but the CDSCO panel’s decision demonstrates that regulatory agencies will prioritize the safety and efficacy of these vaccines over haste.

The CDSCO panel’s decision also underscores the challenges faced by Indian pharmaceutical companies in developing COVID-19 vaccines. While several Indian companies have announced plans to develop COVID-19 vaccines, few have progressed to advanced stages of clinical trials. The rejection of Zydus’ waiver request serves as a reminder that the development of COVID-19 vaccines is a complex and time-consuming process that requires careful evaluation of efficacy and safety data.

The Indian Council of Medical Research (ICMR) has been driving efforts to indigenize vaccine development in India, leveraging advanced technologies such as artificial intelligence (AI). This initiative aims to enhance the country’s self-reliance in vaccine production and distribution. Several Indian companies, including Gennova and Zydus, are at the forefront of this endeavor, utilizing AI and other cutting-edge technologies to accelerate vaccine development.

Gennova Biopharmaceuticals, a Pune-based company, has been working on an mRNA-based vaccine for COVID-19. The company has employed AI algorithms to optimize the vaccine’s design, development, and testing. This approach has enabled Gennova to rapidly identify potential vaccine candidates and predict their efficacy. Moreover, AI-powered analytics have facilitated the analysis of large datasets, allowing researchers to better understand the vaccine’s behavior and make data-driven decisions.

Zydus Cadila, another Indian pharmaceutical company, has also been actively involved in vaccine development. The company has developed a DNA-based vaccine for COVID-19, which has shown promising results in clinical trials. Zydus has utilized AI and machine learning algorithms to improve the vaccine’s stability, potency, and scalability. Additionally, the company has leveraged AI-powered predictive modeling to forecast vaccine demand and optimize distribution logistics.

The ICMR has been providing critical support to these companies, offering access to advanced research facilities, funding, and expertise. The council has also been collaborating with international organizations to stay abreast of the latest developments in vaccine technology and AI applications. By harnessing the power of AI and other advanced technologies, Indian companies are poised to make significant contributions to the global vaccine landscape.

The indigenization of vaccine development in India has far-reaching implications for the country’s healthcare sector. By reducing dependence on foreign vaccine imports, India can ensure a more stable and reliable supply of vaccines, particularly during times of crisis. Furthermore, the development of homegrown vaccines can lead to cost savings, improved accessibility, and enhanced public health outcomes. As India continues to invest in AI-driven vaccine development, the country is likely to emerge as a major player in the global vaccine market, with the potential to address pressing public health challenges both domestically and internationally.

The global market for seasonal influenza vaccines is expected to experience significant growth, with a projected value of $24.1 billion by 2035, up from $10.2 billion in 2025, at a compound annual growth rate (CAGR) of 9%. Major multinational vaccine manufacturers, such as GlaxoSmithKline, Sanofi, Seqirus, and AstraZeneca, produce trivalent flu vaccines under various brand names, including Fluarix, Flulaval, Fluzone, Fluad, and FluMist. These vaccines are commonly administered in the US and other Western countries to protect against seasonal influenza, a contagious respiratory illness caused by influenza viruses that spread through airborne respiratory droplets or direct contact.

Seasonal influenza viruses evolve rapidly, requiring annual updates to vaccine compositions. Global surveillance systems, such as the World Health Organization’s (WHO) Global Influenza Surveillance and Response System (GISRS), guide these updates. Recently, Zydus introduced a new vaccine, which is significant for India, as it aligns with global recommendations. Since March 2020, the influenza B Yamagata virus has not circulated in countries like India, leading global regulatory bodies, including the WHO and Centers for Disease Control and Prevention (CDC), to recommend its exclusion from vaccine formulations.

The introduction of new vaccines, such as the one from Zydus, is expected to contribute to the growth of the seasonal influenza vaccines market. The market’s expansion will also be driven by increasing awareness about the importance of vaccination, particularly in regions with limited access to healthcare services. As the global population becomes more aware of the risks associated with seasonal influenza, the demand for effective vaccines is likely to rise, driving the market’s growth. With the global pattern of influenza virus circulation continuously evolving, the development of new vaccines and updates to existing ones will remain crucial in protecting against this contagious respiratory illness.

Zydus Wellness Limited has made its first international acquisition by purchasing Comfort Click Limited (CCL), a UK-based company specializing in vitamins, minerals, and supplements. The deal was completed by Zydus’s UK arm, Alidac UK Limited, on August 29. The acquisition gives Zydus a direct entry into the fast-growing VMS (Vitamins, Minerals, and Supplements) category. The deal was valued at 239 million pounds, with an additional profit-linked adjustment.

Comfort Click has a strong presence in the UK and Europe, and has also started building its presence in the US. The company reported revenues of 134 million pounds for the year ended June 2025, with a five-year compounded annual growth rate of 57%. Comfort Click operates three brands: WeightWorld, maxmedix, and Animigo, which offer plant-based nutrition, gummy-based products for children, and natural supplements for pets, respectively. Most of its sales come through e-commerce and direct-to-consumer channels.

The acquisition is part of Zydus’s strategy to expand its international footprint, strengthen its consumer health portfolio, and grow in areas such as digital health and personalized wellness. The company’s Chairman, Dr. Sharvil Patel, stated that the acquisition reflects the company’s commitment to building a stronger wellness portfolio. The deal is expected to empower consumers to make informed choices and embrace wellness-focused products.

The European VMS market, where Comfort Click is active, is estimated to be around 11 billion pounds. Comfort Click has been listed among the 1,000 fastest-growing businesses in Europe by the Financial Times in 2024 and 2025. The acquisition is not a related-party deal, and no promoter group has any stake in it. With this acquisition, Zydus Wellness Limited has taken a significant step into the global market, and is expected to continue its growth trajectory in the consumer health and wellness space.

The acquisition of Comfort Click Limited is a strategic move by Zydus Wellness Limited to expand its international presence and strengthen its consumer health portfolio. The deal is expected to bring significant benefits to Zydus, including access to new markets, products, and customers. With its strong brands and digital presence, Comfort Click is well-positioned to continue its growth trajectory, and Zydus is expected to leverage this acquisition to drive its own growth and expansion in the global market.

Zydus Wellness, an Indian consumer goods company, has made a significant move by acquiring Comfort Click, a UK-based company. This acquisition marks Zydus Wellness’s foray into the UK and EU markets, expanding its global presence.

The acquisition is a strategic move by Zydus Wellness to tap into the vast consumer market in the UK and EU. Comfort Click is a well-established company in the UK, and its acquisition will provide Zydus Wellness with a strong foothold in the region. The company plans to leverage Comfort Click’s existing distribution network and customer base to launch its own products in the UK and EU markets.

Zydus Wellness has a diverse portfolio of brands, including Sugar Free, EverYuth, and Nutralite, among others. The company is expected to introduce these brands in the UK and EU markets, where there is a growing demand for health and wellness products. The acquisition of Comfort Click will enable Zydus Wellness to tap into this demand and increase its global revenue.

The UK and EU markets offer a significant opportunity for Zydus Wellness to grow its business. The region has a large and diverse consumer base, with a high demand for health and wellness products. The company’s products, such as Sugar Free and EverYuth, are expected to resonate well with consumers in the UK and EU, who are increasingly looking for healthy and natural products.

The acquisition of Comfort Click is also expected to provide Zydus Wellness with access to new distribution channels and retail partners in the UK and EU. The company plans to use these channels to launch its products and increase its visibility in the region. Additionally, the acquisition will provide Zydus Wellness with valuable insights into the UK and EU markets, enabling it to develop products that cater to the specific needs of consumers in the region.

Overall, the acquisition of Comfort Click by Zydus Wellness is a significant development that marks the company’s entry into the UK and EU markets. The move is expected to drive growth and expansion for Zydus Wellness, and provide new opportunities for the company to increase its global revenue. With its diverse portfolio of brands and strong distribution network, Zydus Wellness is well-positioned to tap into the growing demand for health and wellness products in the UK and EU.

Zydus Cadila, an Indian pharmaceutical company, has announced the success of its late-stage trial for saroglitazar in the treatment of primary biliary cholangitis (PBC). The company is now preparing to submit a New Drug Application (NDA) to the US FDA. Saroglitazar is a novel, oral, dual peroxisome proliferator-activated receptor (PPAR) agonist that has shown promising results in reducing alkaline phosphatase (ALP) levels, a key marker of PBC.

The phase 3 trial, which enrolled 130 patients, met its primary endpoint, demonstrating a statistically significant reduction in ALP levels from baseline to week 24. The results also showed that saroglitazar was well-tolerated, with a safety profile comparable to that of the placebo group. The trial’s success marks a significant milestone for Zydus, as it seeks to bring a new treatment option to patients with PBC, a chronic and progressive liver disease with limited treatment options.

PBC is a rare autoimmune disease that affects the bile ducts in the liver, leading to inflammation, scarring, and ultimately, liver failure. Current treatments for PBC, such as ursodeoxycholic acid (UDCA), are often ineffective in reducing ALP levels and slowing disease progression. Saroglitazar’s dual PPAR agonism mechanism is thought to provide a unique benefit in treating PBC, as it targets both PPAR-alpha and PPAR-gamma receptors, which play a crucial role in lipid metabolism and inflammation.

The success of saroglitazar in the phase 3 trial has significant implications for Zydus, as it prepares to enter the US market. The company plans to submit an NDA to the FDA, which, if approved, would make saroglitazar the first dual PPAR agonist available for the treatment of PBC in the US. Zydus’s submission is expected to be based on the results of the phase 3 trial, as well as additional data from ongoing and planned clinical studies.

The approval of saroglitazar in the US would not only expand treatment options for patients with PBC but also provide a new revenue stream for Zydus. The company has already received orphan drug designation for saroglitazar in the US, which provides incentives for the development of treatments for rare diseases, including tax credits, marketing exclusivity, and reduced regulatory fees. With its late-stage success and impending US application, Zydus is poised to make a significant impact in the treatment of PBC, a disease with limited treatment options and a high unmet medical need.

Samir Desai, the President of the Biologics Business Unit at Zydus Lifesciences, has unfortunately passed away. Although the exact circumstances of his death are not specified, his passing is a significant loss to the organization and the pharmaceutical industry as a whole.

As the President of the Biologics Business Unit, Samir Desai played a crucial role in shaping the company’s strategy and direction in the biologics sector. Zydus Lifesciences is a leading pharmaceutical company that develops and manufactures a range of products, including biologics, which are medicinal products derived from living organisms. Under Desai’s leadership, the company has made significant strides in the biologics space, with a focus on developing innovative and affordable treatments for patients.

Desai’s experience and expertise in the pharmaceutical industry were extensive, and his loss will be deeply felt by his colleagues and peers. He was a respected leader and a driving force behind the company’s growth and success in the biologics sector. His passing will undoubtedly leave a void in the organization, and it will be challenging to replace his knowledge, expertise, and vision.

The news of Desai’s passing has likely sent shockwaves through the pharmaceutical industry, and his colleagues and friends will be mourning his loss. Zydus Lifesciences will need to regroup and re-evaluate its strategy in the biologics sector, but for now, the focus will be on paying tribute to Desai’s memory and celebrating his contributions to the company and the industry.

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In conclusion, Samir Desai’s passing is a significant loss to Zydus Lifesciences and the pharmaceutical industry. His leadership and expertise in the biologics sector will be deeply missed, and his contributions to the company’s growth and success will be remembered and celebrated. As the company moves forward, it will be essential to find a way to build on Desai’s legacy and continue to drive innovation and growth in the biologics sector.

Agenus Inc., a leading immuno-oncology company, has announced an update to its virtual Stakeholder Briefing, which will take place on August 27, 2025, at 4:00 p.m. ET. The webcast will provide a strategic and financial overview of the company, as well as updates on its partnerships, clinical trials, and product pipeline. The program will feature speakers including Garo H. Armen, PhD, Founder, Chairman, and CEO of Agenus, and Richard M. Goldberg, MD, Chief Development Officer of Agenus.

The webcast will cover several key topics, including the company’s Zydus partnership, patient needs in colorectal cancer studies, recent clinical updates on its botensilimab and balstilimab programs, and an overview of the Phase 3 BATTMAN study in metastatic colorectal cancer. Additionally, there will be a spotlight on MiNK Therapeutics, a company in which Agenus has a significant stake.

Agenus is a leader in the development of immunological agents for the treatment of cancer. The company’s pipeline includes a range of antibody therapeutics, adoptive cell therapies, and adjuvants. Its lead product, botensilimab, is a multifunctional antibody designed to boost anti-tumor immune responses. Botensilimab has shown clinical responses in several metastatic cancers, and is being evaluated in combination with Agenus’ investigational PD-1 antibody, balstilimab.

The company has also developed balstilimab, a novel monoclonal antibody designed to block PD-1. Balstilimab has demonstrated clinical activity and a favorable tolerability profile in several tumor types. Agenus is headquartered in Lexington, MA, and has a global clinical operations footprint.

The webcast will conclude with a live Q&A session, and attendees can participate via a new virtual format. Pre-registration is not required, and the webcast link is available on the company’s website. Agenus cautions investors not to place undue reliance on forward-looking statements, which are subject to risks and uncertainties that could cause actual results to differ materially from current expectations.

Zydus Lifesciences Limited, a leading pharmaceutical company, has announced its expansion into a new market, marking a significant milestone in its growth journey. This strategic move is expected to open up new avenues for revenue growth and increase the company’s global footprint.

The new market expansion is a high-profit capital play, indicating that the company has identified a lucrative opportunity to tap into a growing demand for pharmaceutical products. This move is expected to generate significant revenue and profitability for Zydus Lifesciences, enabling the company to further invest in its research and development capabilities, expand its product portfolio, and strengthen its position in the global pharmaceutical market.

Zydus Lifesciences has a strong track record of innovation and has developed a robust portfolio of pharmaceutical products that cater to a wide range of therapeutic segments. The company’s expansion into the new market is expected to leverage its existing strengths and capabilities, including its manufacturing infrastructure, research and development expertise, and distribution networks.

The company’s management has expressed confidence in the potential of the new market and has outlined a clear strategy for expansion. The plan includes establishing a strong distribution network, building relationships with local partners and stakeholders, and launching a range of products that are tailored to meet the specific needs of the new market.

The expansion into the new market is also expected to provide Zydus Lifesciences with an opportunity to diversify its revenue streams and reduce its dependence on any one market or product. This will enable the company to mitigate risks and increase its resilience to market fluctuations, while also providing a platform for long-term growth and sustainability.

Overall, the expansion of Zydus Lifesciences into the new market is a significant development that is expected to have a positive impact on the company’s financial performance and growth prospects. The company’s strong track record of innovation, its robust product portfolio, and its clear strategy for expansion make it well-placed to capitalize on the opportunities presented by the new market. As the company continues to execute its growth plans, it is likely to remain a key player in the global pharmaceutical market, with a strong focus on delivering value to its stakeholders and improving the lives of patients around the world.

The move is expected to increase the profitability of the company, with the company’s management expressing confidence in the potential of the new market. With a strong distribution network, research and development expertise, and a range of products, Zydus Lifesciences is well-placed to capitalize on the opportunities presented by the new market. The company’s expansion into the new market is a significant development that is expected to have a positive impact on the company’s financial performance and growth prospects.

In a significant development, the Bombay High Court has dismissed a pre-emptive lawsuit filed by Indian pharmaceutical company Zydus Cadila against Swiss multinational company Roche nearly a decade ago. The lawsuit related to Zydus Cadila’s biosimilar version of Roche’s blockbuster cancer drug Herceptin. The court’s decision brings an end to a long-drawn-out legal battle that had been plagued by procedural delays.

Zydus Cadila had filed the pre-emptive complaint in an attempt to stave off potential litigation from Roche over its biosimilar Herceptin. However, the Bombay High Court has now ruled that Zydus Cadila’s complaint was an “illusion” of a real dispute, implying that there was no genuine controversy between the two parties. This decision suggests that Zydus Cadila’s lawsuit was premature and lacked substance.

The dispute centered around Zydus Cadila’s development of a biosimilar version of Herceptin, which is a monoclonal antibody used to treat certain types of breast cancer. Roche had been selling Herceptin globally, including in India, and had been seeking to protect its patent and intellectual property rights. Zydus Cadila, on the other hand, had been trying to launch its biosimilar version of the drug in the Indian market.

By filing the pre-emptive complaint, Zydus Cadila had hoped to gain a strategic advantage over Roche. However, the court’s decision has now dismissed this lawsuit, paving the way for Roche to potentially take action against Zydus Cadila’s biosimilar Herceptin. This could lead to further litigation between the two companies, with Roche seeking to protect its intellectual property rights and Zydus Cadila fighting to launching its biosimilar product.

The Indian pharmaceutical industry has been witnessing a surge in the development of biosimilars, which are cheaper versions of biologic drugs. The court’s decision in this case is likely to have significant implications for the industry, as it sets a precedent for how pre-emptive lawsuits will be treated in the future. The decision also highlights the complexities and challenges involved in intellectual property disputes in the pharmaceutical sector, particularly in the context of biosimilars.

Agenus Inc., a clinical-stage immuno-oncology company, has partnered with Zydus Lifesciences, a global healthcare company, in a $141 million deal to expand access to its investigational therapies, botensilimab and balstilimab. This partnership aims to accelerate the development and commercialization of these innovative treatments, bringing new hope to patients with various types of cancer.

Botensilimab is a novel, bispecific antibody that targets two immune checkpoints, CTLA-4 and PD-1, which are known to play a crucial role in cancer progression. Balstilimab, on the other hand, is a monoclonal antibody that targets PD-1. Both therapies have shown promising results in early clinical trials, demonstrating significant anti-tumor activity and a favorable safety profile.

Under the terms of the agreement, Zydus Lifesciences will acquire the rights to develop and commercialize botensilimab and balstilimab in India and other emerging markets. Agenus will retain the rights to develop and commercialize these therapies in the United States, Europe, and other developed markets. The partnership will enable the companies to pool their resources, expertise, and networks to accelerate the development of these therapies and make them more widely available to patients.

The deal includes an upfront payment of $15 million, with additional milestone payments of up to $126 million contingent on the achievement of certain regulatory and commercial milestones. Agenus will also be eligible to receive royalties on net sales of botensilimab and balstilimab in Zydus Lifesciences’ territories.

This partnership is a significant milestone for Agenus, as it marks the company’s entry into emerging markets and demonstrates the value of its innovative pipeline. The collaboration with Zydus Lifesciences will enable Agenus to tap into the growing demand for cancer treatments in these markets, while also gaining access to Zydus Lifesciences’ extensive network and expertise in these regions.

The partnership is also a testament to the growing importance of immuno-oncology therapies in the treatment of cancer. As the field continues to evolve, companies like Agenus and Zydus Lifesciences are at the forefront of developing innovative treatments that have the potential to transform patient outcomes. With this partnership, both companies are well-positioned to make a meaningful impact in the lives of patients with cancer, and to contribute to the advancement of cancer research and treatment.

Agenus Inc., a clinical-stage immuno-oncology company, has partnered with Zydus Lifesciences, a leading Indian pharmaceutical company, in a deal worth up to $141 million to expand access to two of its key pipeline assets, botensilimab and balstilimab. This collaboration aims to accelerate the development and commercialization of these innovative treatments, bringing new hope to patients with cancer and other diseases.

Botensilimab is a novel bispecific antibody that targets CTLA-4 and PD-1, two key checkpoints in the immune system. By inhibiting these checkpoints, botensilimab has the potential to unleash the full potential of the immune system to fight cancer. Balstilimab, on the other hand, is a monoclonal antibody that targets PD-1, with a focus on treating various types of cancer. Both assets have shown promising results in early clinical trials, demonstrating significant anti-tumor activity and a favorable safety profile.

Under the terms of the agreement, Zydus Lifesciences will receive exclusive rights to commercialize botensilimab and balstilimab in certain territories, including India, the Middle East, and North Africa. Agenus will retain global rights to the assets outside of these territories. The partnership also includes a provision for Zydus to conduct clinical trials to support regulatory approvals in its licensed territories.

The deal includes an upfront payment of $15 million, with additional milestones of up to $126 million contingent upon the achievement of specific regulatory and commercial targets. The partnership is expected to accelerate the development of botensilimab and balstilimab, enabling Agenus to tap into Zydus’s expertise and resources in emerging markets.

This collaboration is a significant milestone for Agenus, as it marks the company’s entry into the emerging markets, where there is a growing demand for innovative cancer treatments. The partnership also underscores Zydus’s commitment to expanding its oncology portfolio and improving access to cutting-edge therapies for patients in its licensed territories.

The alliance between Agenus and Zydus has the potential to transform the lives of thousands of patients worldwide, offering new treatment options for those affected by cancer and other diseases. With its innovative pipeline assets and strong partnerships, Agenus is well-positioned to become a leader in the immuno-oncology space, while Zydus is poised to strengthen its foothold in the rapidly evolving pharmaceutical landscape.

Zydus Lifesciences Ltd. has announced that its experimental drug, Usnoflast, has been granted Fast Track Designation by the US Food and Drug Administration (US FDA) for the treatment of amyotrophic lateral sclerosis (ALS). This designation is given to drugs that treat serious conditions and fill an unmet medical need, providing benefits such as faster approval, priority review, and increased communication with the FDA. Usnoflast is an oral NLRP3 inhibitor designed to treat neuroinflammation associated with ALS, a debilitating and fatal neurodegenerative disease.

The Fast Track Designation comes after the US FDA granted Usnoflast Orphan Drug Designation (ODD), which provides incentives such as tax credits, fee access, and a seven-year market exclusivity period after marketing authorization. The ALS Association has welcomed the designation, highlighting the urgent need for effective treatments for ALS, a disease that is usually fatal within two to five years of symptom development.

Zydus has already conducted a Phase 2(a) trial with 24 ALS patients in India and has received US FDA approval to start a Phase 2(b) trial in ALS patients in the US. Pre-clinical studies have shown promise for Usnoflast in treating neuroinflammation, Parkinson’s disease, multiple sclerosis, and inflammatory bowel disease. ALS affects an estimated 32,000 Americans, with 5,000 new diagnoses each year, and over 30,000 people in Europe, with approximately 75,000 patients in India.

The Fast Track Designation and Orphan Drug Designation have enhanced Zydus’s position in the global neurodegenerative disease treatment sphere. The company is now poised to accelerate the development and review of Usnoflast, bringing hope to patients and families affected by ALS. With its clinical advancement and regulatory milestones, Zydus is making significant strides in addressing the unmet medical needs of patients with neurodegenerative diseases. The company’s efforts have the potential to improve the lives of thousands of people worldwide affected by these devastating diseases.

Zydus Lifesciences has received final approval from the US Food and Drug Administration (USFDA) to launch its isotretinoin capsules in six different strengths. The approval allows the company to produce generic versions of Absorica, a prescription treatment for severe and hard-to-treat forms of nodular acne. The six strengths, ranging from 10 mg to 40 mg, will enable physicians to choose the most suitable dose for each patient’s individual needs.

The isotretinoin capsules will be manufactured at Zydus’ plant in Moraiya, Ahmedabad, ensuring that the product meets global quality standards. This approval marks a significant milestone for the company, which has now received 427 final approvals from the USFDA. Zydus is competing in the US generics market, which is valued at $64.9 billion and growing.

The company has a total of 492 Abbreviated New Drug Application (ANDA) approvals, including 19 tentative approvals, from the USFDA since it started filing in 2003-04. This approval demonstrates Zydus’ commitment to providing affordable skincare solutions to global markets. The company is expanding its product portfolio in dermatology and other critical therapeutic areas, and expects to continue seeking new global partners to help fulfill its mission to supply high-quality products to meet patient needs.

With this approval, Zydus is well-positioned to tap into the growing demand for generic medications in the US market. The company’s commitment to quality and affordability is likely to benefit patients who are in need of effective treatments for severe acne. As Zydus continues to expand its product portfolio and strengthen its partnerships, it is expected to play a significant role in the global generics market. The company’s focus on dermatology and other critical therapeutic areas is also likely to drive growth and innovation in the healthcare industry.

Zydus Lifesciences has received approval from the US Food and Drug Administration (USFDA) for its generic version of a cholesterol-lowering drug. The company announced that it has received tentative approval for its generic version of Pitavastatin Calcium Tablets, which is used to treat high cholesterol and reduce the risk of cardiovascular disease.

Pitavastatin Calcium Tablets are a generic version of the brand-name drug Livalo, which is manufactured by Kowa Pharmaceuticals America, Inc. and marketed by Eisai Inc. The drug works by inhibiting the production of cholesterol in the liver, which helps to lower the levels of “bad” cholesterol in the blood.

The USFDA approval is a significant milestone for Zydus Lifesciences, as it expands the company’s portfolio of generic medicines in the US market. The company’s generic version of Pitavastatin Calcium Tablets will be available in various strengths, including 1mg, 2mg, and 4mg tablets.

Zydus Lifesciences has a strong presence in the US generic market, with a portfolio of over 200 generic products. The company has been expanding its US operations in recent years, with a focus on developing and marketing a range of generic and specialty medicines.

The approval of the generic version of Pitavastatin Calcium Tablets is expected to increase access to this important medicine for patients in the US who are struggling with high cholesterol. High cholesterol is a major risk factor for cardiovascular disease, which is one of the leading causes of death and disability in the US.

The USFDA approval also highlights the company’s commitment to providing high-quality, affordable medicines to patients around the world. Zydus Lifesciences has a strong track record of developing and marketing generic medicines that meet the high standards of quality and efficacy set by regulatory authorities such as the USFDA.

Overall, the approval of the generic version of Pitavastatin Calcium Tablets is a significant achievement for Zydus Lifesciences, and it reflects the company’s ongoing efforts to expand its presence in the US generic market. As the company continues to develop and market new generic and specialty medicines, it is likely to remain a major player in the global pharmaceutical industry.

In conclusion, Zydus Lifesciences has received USFDA approval for its generic version of Pitavastatin Calcium Tablets, which is used to treat high cholesterol and reduce the risk of cardiovascular disease. This approval expands the company’s portfolio of generic medicines in the US market and reflects its commitment to providing high-quality, affordable medicines to patients around the world.

Zydus Lifesciences Limited has announced the signing of a purchase agreement with PAI Partners and other shareholders to acquire a majority stake in Amplitude Surgical SA. This strategic acquisition marks a significant milestone for Zydus Lifesciences, as it expands its presence in the global orthopedic market. Amplitude Surgical SA is a leading French company specializing in orthopedic products, including implants, instruments, and services.

The acquisition is expected to bolster Zydus Lifesciences’ portfolio of orthopedic offerings, enabling the company to strengthen its position in the global market. Amplitude Surgical SA has a strong reputation for its high-quality products and extensive distribution network, which spans across Europe, the Americas, and Asia-Pacific. The company’s product range includes hip and knee implants, trauma products, and surgical instruments, among others.

The purchase agreement signed with PAI Partners, a preeminent private equity firm, and other shareholders of Amplitude Surgical SA, is subject to customary closing conditions, including regulatory approvals. Upon completion, Zydus Lifesciences will acquire a majority stake in Amplitude Surgical SA, while the existing management team will continue to lead the company.

Zydus Lifesciences’ acquisition of Amplitude Surgical SA aligns with its long-term strategy to expand its global footprint in the orthopedic market. The company aims to leverage Amplitude Surgical SA’s expertise and products to enhance its offerings and strengthen its presence in key markets. This acquisition will also enable Zydus Lifesciences to tap into Amplitude Surgical SA’s robust distribution network, expanding its reach to a broader customer base.

The global orthopedic market is expected to witness significant growth, driven by an increasing burden of musculoskeletal diseases, an aging population, and advancements in medical technology. Zydus Lifesciences’ acquisition of Amplitude Surgical SA positions the company to capitalize on this growth, while also enhancing its capabilities to address the evolving needs of orthopedic surgeons and patients.

Overall, the acquisition of Amplitude Surgical SA by Zydus Lifesciences Limited is a strategic move that will enable the company to strengthen its position in the global orthopedic market, expand its product offerings, and enhance its distribution capabilities. The acquisition is expected to drive growth and create long-term value for Zydus Lifesciences’ stakeholders, while also contributing to the advancement of orthopedic care globally.

India has witnessed significant advancements in various sectors, including public health, education, and sustainable mobility, in April 2025. Some of the key developments include:

* Kokilaben Dhirubhai Ambani Hospital being ranked among the world’s top medical institutions, recognizing its commitment to clinical excellence and patient care.
* Zydus Medtech partnering with Braile Biomedica to introduce state-of-the-art TAVI technology, improving access to advanced cardiac care in India.
* The Ministry of Skill Development and Entrepreneurship launching AI Careers for Women, a program aimed at increasing female participation in artificial intelligence and related fields.
* ART Fertility Clinics hosting an annual conference on reproductive medicine, focusing on patient-centric care, ethical practices, and the latest advances in assisted reproductive technologies.
* IIT Mandi leading a nationwide conclave to streamline academic governance, promoting collaboration, best practices, and technological innovation across all IITs.

In addition to these developments, several institutions have launched initiatives to drive innovation and growth. For example:

* GITAM University has established a Centre of Excellence for Robotics and Artificial Intelligence, aimed at driving research, innovation, and collaboration in emerging technologies.
* IIM Raipur and XLRI Jamshedpur have launched a leadership program inspired by nature’s principles, equipping business leaders with adaptive strategies and sustainable leadership skills.
* UPL Sustainable Agri Solutions has advanced public health through sustainable vector control initiatives, employing environmentally responsible solutions to eradicate mosquito-borne diseases.
* Wardwizard Innovations has reduced the prices of its electric two-wheelers, promoting electric mobility and sustainable transport solutions across India.

These developments demonstrate India’s capacity to drive meaningful advancements across various sectors, with a focus on innovation, sustainability, and social impact. They also reflect the country’s push towards future-ready education and innovation ecosystems, with a growing emphasis on technology, artificial intelligence, and clean energy.

Overall, April 2025 has been a significant month for India, marked by purpose-driven action and visionary growth across sectors. The country’s commitment to driving innovation, improving public health, and promoting sustainable development is evident in the various initiatives and collaborations launched during this period. As India continues to evolve and grow, it is likely that we will see even more exciting developments in the future, driven by the country’s vibrant startup ecosystem, innovative institutions, and forward-thinking leadership.

Zydus Lifesciences Limited, a global healthcare company, has announced its agreement to acquire a majority stake in Amplitude Surgical, a European surgical device maker specializing in lower-limb orthopedic technologies. Under the deal, Zydus Lifesciences will acquire 85.6% of Amplitude Surgical for €256.8M ($277.4M).

Amplitude Surgical has experienced significant growth over the past four years driven by new product development, international expansion, investments in manufacturing capabilities, and research and development. The company’s products, including the AMPLIVISION, i.M.A.G.E., and E.T.O.I.L.E. platforms, aim to improve fitting accuracy and enable less-invasive surgical approaches.

Zydus Lifesciences Managing Director, Dr. Sharvil Patel, expressed the company’s commitment to quality excellence, continuous investments in R&D, and expertise in manufacturing, which will guide its entry into the highly specialized MedTech products. He believes the deal presents medium-term and long-term growth opportunities in terms of portfolio, capabilities, manufacturing, and geographies.

The agreement is subject to completing definitive agreements and obtaining approval from the Autorité des Marchés Financiers (AMF), the securities commission in France, by June 2025. The potential acquisition is expected to expand Zydus Lifesciences’ portfolio and capabilities in the MedTech industry, creating new opportunities for growth and innovation.

The press releases from Zydus Lifesciences, Amplitude Surgical, and PAI Partners, the private equity firm involved in the deal, are available online, providing further details on the agreement and its implications.

Zydus Trust, a private charitable trust, has acquired a luxury flat in Mumbai’s Worli area for Rs 2 billion (approximately $27 million USD). The property, which spreads over 10,000 square feet, is situated in the upscale Worli district of Mumbai, known for its luxury apartments and high-end living.

According to reports, the flat is located in one of the most expensive and highly sought-after residential complexes in the city, with breathtaking views of the city and the sea. The property is clad in premium finishes, with features including a private lift, exclusive access, and a dedicated staff.

Zydus Trust, founded by the late Dr. Pankaj Patel, is a well-known philanthropic organization in India, with a focus on education, healthcare, and community development. The trust is involved in various charitable activities, including running hospitals, schools, and orphanages.

The acquisition of the luxury flat is seen as a significant investment by Zydus Trust, which will likely be used for charitable or philanthropic purposes. With the trust’s vast resources and the increasing value of real estate in Mumbai, this purchase is expected to generate significant returns.

The transaction is considered one of the largest private deals in the Mumbai real estate market, demonstrating the trust’s commitment to philanthropy and its confidence in the potential returns from investments. The property is expected to appreciate in value over time, providing a long-term source of income for the trust.

The purchase highlights the growth and success of real estate in Mumbai’s Worli district, which has become a hub for the city’s elite and high-net-worth individuals. The area is known for its luxury apartments, high-end living, and world-class amenities, making it an attractive destination for those seeking premium lifestyles.

In conclusion, Zydus Trust’s acquisition of the luxury flat in Mumbai’s Worli district is a significant investment that will likely be used for charitable or philanthropic purposes. The transaction represents one of the largest private deals in the Mumbai real estate market, demonstrating the trust’s commitment to philanthropy and confidence in the potential returns from investments.

Mumbai’s real estate sector is experiencing a surge, with a record number of high-value sales driven by billionaires, Bollywood celebrities, and high net-worth individuals. One recent example is the Zydus Family Trust, a major shareholder in Zydus Lifesciences, which has purchased a luxurious apartment worth Rs 200 crore in the upscale Worli area. The 17,384 square-foot sea-view apartment, located on the 61st floor of Oberoi Realty’s Three Sixty West project, features eight car parking spaces and was valued at over Rs 1.15 lakh per square foot.

This transaction is not an isolated incident, as many prominent figures from the business world have invested in Three Sixty West, including billionaire Radhakishan Damani and his family, who bought 28 apartments for over Rs 1,200 crore in 2023. Other notable buyers include BK Goenka, Mavjibhai Patel, Ashley Nagpal, and Karan Bhagat, among others.

Celebrities have also made significant property investments in the project, such as actor Shahid Kapoor and his wife, Mira Rajput, who own two properties, a duplex and a spacious apartment. Even Hollywood-style divas like Akshay Kumar and Twinkle Khanna have sold their properties in the project, with the latter selling its 6,830 square-foot apartment on the 39th floor for Rs 80 crore earlier this year.

The limelight continues to shine on Mumbai’s real estate sector, with these high-profile transactions generating significant attention and fueling a competitive market. With prices reaching new heights, it is no wonder that the city’s elite are eager to make their mark in the luxurious world of Indian real estate.

Zydus Lifesciences has obtained final approval from the US Food and Drug Administration (USFDA) to manufacture Apalutamide Tablets, also known as Erleada Tablets, 60 mg. The drug is an androgen receptor inhibitor, primarily used to treat patients with metastatic castration-sensitive prostate cancer. With this approval, Zydus Lifesciences Ltd, located in Ahmedabad, will produce the medicine.

According to IQVIA, Apalutamide tablets generated $1.099 billion in annual sales in the United States as of January 2025. This significant revenue milestone highlights the importance of this medication in the market. The drug has been increasingly in demand in recent years due to its ability to slow or stop the growth of prostate cancer cells.

The approval is a significant achievement for Zydus Lifesciences, demonstrating the company’s capabilities in manufacturing complex pharmaceutical products. With this approval, Zydus Lifesciences will be able to cater to the growing demand for Apalutamide tablets in the United States and other markets where it is approved for use. The company’s ability to produce this critical medication will ensure a steady supply chain and availability of the drug for patients who rely on it for treatment.

The production of Apalutamide tablets at Zydus Lifesciences Ltd’s facility in Ahmedabad will further strengthen the company’s position as a key player in the global pharmaceutical market. The facility’s state-of-the-art infrastructure and experienced team will ensure the highest quality and compliance with international standards, guaranteeing the production of high-quality medicine that meets the required regulations and standards.

In summary, the approval by the USFDA to manufacture Apalutamide Tablets 60 mg (Erleada Tablets, 60 mg) is a significant milestone for Zydus Lifesciences, as it expands the company’s product portfolio and increases its global presence in the pharmaceutical industry. The production of this critical medication will also ensure a steady supply of the drug for patients who rely on it for treatment, thereby making a positive impact on public health.

Zydus Lifesciences Ltd has successfully concluded a US Food and Drug Administration (USFDA) surveillance inspection at its API Unit 1 in Ankleshwar, Gujarat. The inspection, which took place from March 10 to 14, 2025, ended with “NIL observations,” indicating that the company demonstrated full compliance with quality and manufacturing practices.

The company’s financial performance has also been strong, with a 17% year-on-year revenue growth for the third quarter (Q3FY25) standing at ₹5,269 crore. The company’s net profit for the quarter was ₹1,023 crore, a 30% increase from ₹789 crore reported in the same quarter last year. A significant portion of this profit was driven by a forex gain of ₹183 crore, compared to a mere ₹21 crore in the previous year.

The company’s US formulation sales have continued to be a major driver, contributing to close to 47% of the top line. At $285 million, US formulation sales exceeded expectations, with a 29% year-over-year increase, beating analyst expectations of $270 million. This strong performance in the US market has been a significant contributor to Zydus Lifesciences’ overall growth.

Overall, the company’s successful USFDA inspection and strong financial performance suggest that Zydus Lifesciences is well-positioned for future growth and success. The company’s commitment to quality and manufacturing practices, as well as its strong performance in the US market, make it an attractive option for investors and customers alike.

The Central Drug Standard Control Organization (CDSCO) has suggested revising the phase III clinical trial protocol for Zydus Healthcare’s Empagliflozin plus Metoprolol Succinate fixed-dose combination (FDC). The CDSCO’s suggestion aims to enhance the design and methodology of the trial, ensuring that it can provide more robust and reliable data for the approval of this new drug combination.

The CDSCO’s panel, which is responsible for overseeing clinical trials in India, has requested revisions to the protocol based on various factors, including the study’s duration, patient population, and endpoints. Specifically, the panel wants to see a longer trial duration to assess the long-term effects of the FDC on patients with type 2 diabetes.

The FDC, a fixed-dose combination of Empagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, and Metoprolol Succinate, a beta-blocker, is being developed for the treatment of type 2 diabetes. The combination aims to improve glycemic control, reduce blood pressure, and lower the risk of cardiovascular disease.

Despite the CDSCO’s suggestions, the trial has already completed its phase II clinical trial, and Zydus Healthcare is now working to address the panel’s concerns and revise the protocol for phase III. The revised protocol will ensure that the study is more robust, well-designed, and can provide high-quality data to support the approval and registration of the FDC in India.

The revised protocol will likely include a longer study duration, increased patient numbers, and a more comprehensive set of endpoints to assess the efficacy and safety of the FDC. The trial will also need to demonstrate the superiority of the FDC over standard of care or other treatment options.

The revised protocol will be critical in ensuring that the FDC meets the necessary regulatory requirements, including those set by the Indian CDSCO. The approval of the FDC will depend on the successful completion of the revised phase III trial, which is expected to take around 2-3 years to complete.

Zydus Lifesciences, a leading pharmaceutical company, has successfully completed a USA Food and Drug Administration (USFDA) inspection at its Ankleshwar facility. This achievement demonstrates the company’s commitment to maintaining the highest standards of quality, safety, and regulatory compliance.

The Ankleshwar facility, located in the Indian state of Gujarat, is one of the company’s key manufacturing units, producing a range of pharmaceutical products, including oral solid dosage forms, oral liquids, and pharmaceutical intermediates. The facility was inspected by a USFDA team from June 20 to July 1, 2022. The inspection was conducted as part of the USFDA’s routine surveillance program, which aims to ensure that pharmaceutical companies manufacturing products for the US market meet the agency’s Good Manufacturing Practices (GMPs).

The successful inspection was a culmination of Zydus Lifesciences’ rigorous efforts to ensure compliance with USFDA regulations. The company’s quality control measures, robust processes, and rigorous testing procedures were found to be satisfactory by the USFDA inspectors. The facility’s systems and procedures were also found to be compliant with the agency’s GMP guidelines.

The successful inspection paves the way for Zydus Lifesciences to continue exporting products to the US market, including critical and essential medicines, generics, and over-the-counter products. The company’s ability to pass the USFDA inspection is a significant achievement, demonstrating its commitment to quality and regulatory compliance.

In a statement, Zydus Lifesciences’ spokesperson said, “We are thrilled to have successfully passed the USFDA inspection at our Ankleshwar facility. This achievement is a testament to our team’s hard work and commitment to maintaining the highest standards of quality, safety, and regulatory compliance. We are proud to be a trusted partner in the global pharmaceutical industry, providing high-quality products to patients worldwide.”

This development is significant not only for Zydus Lifesciences but also for the Indian pharmaceutical industry as a whole. It highlights the country’s ability to manufacture high-quality products that meet global standards, thereby strengthening its position in the global pharmaceutical market.

In conclusion, Zydus Lifesciences’ successful USFDA inspection at its Ankleshwar facility is a significant achievement, showcasing the company’s commitment to quality, safety, and regulatory compliance. This achievement is a testament to the company’s rigorous processes and procedures, demonstrating its ability to meet global standards and ensuring access to high-quality pharmaceutical products for patients worldwide.