Latest News on Zydus Lifesciences
Agenus and Zydus Lifesciences have formed a $141 million partnership to increase availability of Botensilimab and Balstilimab.
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 and Zydus Lifesciences enter into a $141 million partnership to increase global accessibility of Botensilimab and Balstilimab treatments.
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 receives US FDA’s fast track designation for its ALS treatment drug, Unsoflast.
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 Receives US FDA Approval for Generic Version of Absorica, Used to Treat Severe Acne
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.
Unlocking the Emerging Opportunities in India’s Pharmaceutical Industry
The Indian pharmaceutical sector has demonstrated robust growth over the past year, driven by a new trade agreement with the European Union that reduces tariffs on key drug exports. This agreement is expected to enhance India’s position as a global supplier of generic medicines, leading to increased trade volume and job creation. The sector has shown positive momentum in the short term, reflecting a steady rise in investor confidence. Analysts project substantial upside potential for various companies operating in this space.
Several top companies in the sector have been identified as having strong upside potential. Cohance Lifesciences Limited, a technology-driven contract development and manufacturing organization, has a target price of Rs. 1400.00, indicating an upside potential of 33%. Piramal Pharma Limited, a global pharmaceutical company, has a target price of Rs. 271.00, reflecting an upside potential of 32%. Natco Pharma Limited, a vertically integrated pharmaceutical company, has a target price of Rs. 1090.00, indicating an upside potential of 28%.
Other companies with strong upside potential include Aurobindo Pharma Limited, which has a target price of Rs. 1470.00, reflecting an upside potential of 23%, and Blue Jet Healthcare Limited, which has a target price of Rs. 943.00, indicating an upside potential of 19%. Zydus Lifesciences Limited, a global life sciences company, has a target price of Rs. 1040.00, reflecting an upside potential of 18%.
Overall, the outlook for the Indian pharmaceutical sector remains positive, driven by the new trade agreement with the European Union and the growth potential of various companies operating in the space. Analysts recommend a strong buy for Cohance Lifesciences and Piramal Pharma, a buy for Aurobindo Pharma and Blue Jet Healthcare, and a hold for Natco Pharma and Zydus Lifesciences.
The financial performance of these companies has been strong, with many reporting significant year-on-year sales growth. However, some companies have seen a decline in profit after tax (PAT) due to various factors. Despite this, the long-term implications of the trade agreement and the growth potential of the sector are expected to drive growth and innovation in the Indian pharmaceutical industry.
Stock Market Updates for Zydus Lifesciences
Recent Updates
Today’s Earnings Schedule: Q4 Results from Hindalco, Dixon Tech, Zydus Life, and Torrent Pharma Released – Expert Earnings Projections
Several Indian companies are set to announce their fourth-quarter results on Tuesday, including Hindalco Industries Ltd., Dixon Technologies (India) Ltd., Zydus Lifesciences Ltd., and Torrent Pharmaceuticals Ltd. According to consensus analysts’ estimates compiled by Bloomberg, here’s what can be expected from each company:
Hindalco Industries Ltd. is expected to report a 6% increase in consolidated revenue, reaching Rs 59,251 crore. The company’s estimated Earnings Before Interest, Taxes, Depreciation, and Amortization (Ebitda) is Rs 8,048 crore, with a margin of 13.6%. The net profit is forecasted to be Rs 3,555 crore.
Dixon Technologies (India) Ltd. is anticipated to report revenue of Rs 10,748 crore, with an Ebitda of Rs 403 crore and a margin of 3.7%. The company’s net profit is expected to be Rs 217 crore.
Zydus Lifesciences Ltd. is expected to report revenue of Rs 6,434 crore, with an Ebitda of Rs 2,026 crore and a margin of 31.5%. The company’s net profit is forecasted to be Rs 1,370 crore.
Torrent Pharmaceuticals Ltd. is estimated to report revenue of Rs 2,988 crore, with an Ebitda of Rs 981 crore and a margin of 32.8%. The company’s net profit is expected to be Rs 524 crore.
These estimates suggest that all four companies are expected to report significant revenue and profit growth in the fourth quarter. Hindalco’s revenue growth is expected to be driven by a rebound in demand for aluminum and copper products. Dixon Technologies’ revenue growth is expected to be driven by an increase in demand for electronic products. Zydus Lifesciences and Torrent Pharmaceuticals are expected to benefit from a strong performance in the pharmaceutical sector.
Overall, the fourth-quarter results of these companies are expected to provide insights into the performance of various industries, including metals, electronics, and pharmaceuticals. The results will also be closely watched by investors and analysts to gauge the impact of various macroeconomic factors on the companies’ performance.
Gujarat’s Vyara Civil Hospital shift to PPP model Spells Agony for Tribals and Patients
In 2020, the NITI Aayog recommended that state governments hand over the management of public hospitals to private players. However, the Gujarat government had already taken this step in 2009, when it privatized the Bhuj Civil Hospital, which was rebuilt after the 2001 earthquake at a cost of Rs 100 crore from the Prime Minister’s Relief Fund. The hospital was handed over to the Adani Foundation on a 99-year lease under a Public-Private Partnership (PPP) model. The hospital was renamed the G.K. General Hospital and integrated with the Gujarat Adani Institute of Medical Sciences (GAIMS), which offers undergraduate and postgraduate courses in medicine.
Since then, the Gujarat government has privatized two more hospitals, the Dahod Civil Hospital, which was handed over to the Zydus Group in 2017, and the Vyara Civil Hospital, which was initially supposed to be handed over to the Torrent Group but was met with protests and has now been taken over by the UNM Foundation, a non-profit arm of the Torrent Group. The privatization of these hospitals has been mired in controversies, with allegations of exorbitant fees being charged to patients, poor treatment, and high infant and child mortality rates.
For instance, between January and May 2018, over 110 newborn babies died at the G.K. General Hospital, and in 2019, the hospital was accused of charging high fees for outpatient department (OPD) treatments, which were previously free. The hospital has also been criticized for the high fees charged for undergraduate and postgraduate courses, with the fee for a five-year MBBS program ranging from Rs 29-43 lakh for government and NRI quota seats, and Rs 80.5 lakh for management quota seats.
Similarly, the Zydus Medical College and Hospital charges Rs 6.85 lakh per year for 132 government quota PG seats, Rs 15 lakh a year for management quota seats, and Rs 19.5 lakh each for the 23 NRI seats. In contrast, the annual fee for a three-year PG program in government-run medical colleges in Gujarat is Rs 25,000, and for a five-year undergraduate program, Rs 15,000.
The companies involved in the privatization of these hospitals have also been accused of having close ties with the BJP government, with the Torrent Group purchasing electoral bonds worth Rs 184 crore between 2019 and 2024, and the Zydus Group giving bonds totaling Rs 29 crore to the BJP between 2022 and 2023. The privatization of these hospitals has raised concerns about the impact on public healthcare in Gujarat, particularly in rural areas where access to healthcare is already limited. The controversy surrounding the privatization of these hospitals highlights the need for greater transparency and accountability in the management of public healthcare facilities.
USFDA approves Zydus Lifesciences’ generic version of a cholesterol-lowering medication.
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 to Acquire Majority Stake in Amplitude Surgical SA via Purchase Agreement with PAI Partners and Other Shareholders – Business Wire
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.
Renowned institutions such as Kokilaben Hospital, Zydus Medtech, MSDE-Microsoft, IIT Mandi, and ART Fertility are key players.
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.
Indian pharmaceutical companies Sun Pharma, Zydus, and Glenmark have issued recalls of their products in the US due to manufacturing concerns.
Three major Indian pharmaceutical companies, Sun Pharma, Zydus, and Glenmark, have issued recalls of their products in the United States due to manufacturing issues. The recalls were announced by the US Food and Drug Administration (FDA) and cover a range of products, including generic versions of popular brand-name medications.
Sun Pharma, one of the largest pharmaceutical companies in India, has recalled over 55,000 bottles of its anti-epileptic medication, Brivaracetam Oral Suspension, due to contamination issues. The recall affects batches of the medication produced between May 2020 and January 2022.
Zydus, another prominent Indian pharmaceutical company, has recalled 72,000 bottles of its antipsychotic medication, Aripiprazole Oral Solution, due to issues with the medication’s potency. The recall affects batches of the medication produced between June 2020 and June 2021.
Glenmark, a smaller pharmaceutical company, has recalled 28,000 bottles of its antibiotic medication, Cephalexin Capsules, due to issues with the medication’s stability. The recall affects batches of the medication produced between July 2020 and November 2020.
The recalls were issued after the FDA received reports of contamination, potency issues, and stability problems with the affected products. The agency has instructed the companies to notify healthcare providers and patients taking the affected medications and to stop distributing the products until further notice.
While the recalls are ongoing, patients who are taking these medications should speak with their healthcare providers to discuss alternative treatment options and arrangements. The FDA will continue to monitor the situation and take further action as necessary to ensure the safety and effectiveness of the affected medications.
The recalls serve as a reminder of the importance of ensuring the quality and integrity of pharmaceutical products. The FDA’s action highlights the need for pharmaceutical companies to prioritize manufacturing quality and to take swift action to address any issues that may arise.
Zydus Lifesciences pursues majority stake in Amplitude Surgical in a €256.8m ($277.4m) deal.
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.
US Announces Plans to Impose Tariffs on Pharma Imports: Impact on India’s $8.7 Billion Market
The US government, under President Donald Trump, has announced plans to impose new tariffs on pharmaceutical imports, which could significantly impact India, the top supplier of generic drugs to the US. The move aims to push pharmaceutical manufacturing back to the US, but analysts warn that it could have far-reaching consequences for both countries. India’s pharmaceutical sector, which generates a significant portion of its revenue from the US market, could face major setbacks. Indian companies such as Dr Reddy’s, Aurobindo Pharma, Sun Pharma, Zydus Lifesciences, and Gland Pharma, which rely on the US market for a substantial part of their revenue, may be particularly affected.
The tariffs, expected to be “major,” could lead to increased costs for US consumers and insurers, and potentially cause inflation and drug shortages. The US heavily relies on low-cost Indian generics to maintain affordability in healthcare, and a tariff regime could disrupt this arrangement. Indian drugmakers already operate on tight margins, and tariffs would force them to raise prices, making their products less competitive in the US market.
As the US government continues to develop its trade policy, Indian pharma exports may face an uncertain future, further adding pressure to the industry grappling with FDA compliance challenges. The US-India trade relationship is already under strain, and the tariff move could exacerbate tensions between the two nations. Analysts warn that both countries will bear the brunt of this move, which could set back India’s competitiveness in the global pharmaceutical market.
Citi cites low risk of US tariffs on Indian pharma, favoring Torrent Pharma and Divi’s.
Citibank has analyzed the potential impact of US tariffs on Indian pharmaceutical companies and has assigned a low probability to such an event. The brokerage firm simulated a 10% tariff scenario and found that companies with a high exposure to US generics, such as Zydus, Dr. Reddy’s Laboratories, and Aurobindo Pharma, could face a 9-12% reduction in earnings before interest, taxes, depreciation, and amortization (EBITDA). However, if part of the tariffs is passed on to buyers, the impact could be reduced to 5-6%.
On the other hand, companies with lower exposure to US generics, such as Torrent Pharma, Sun Pharma, and Divi’s Laboratories, would be less affected, with an estimated 1-3% hit to EBITDA. Citi’s preferred picks in the Indian pharmaceutical sector, these companies have diversified portfolios and are less reliant on the US generics market.
The report also notes that if tariffs are imposed, they may not be fully passed on to US buyers due to various factors, including competition, industry fragmentation, and the influence of buying consortiums focused on lowering prices. Citi believes that the probability of tariffs on Indian generics is low, citing the limited manufacturing of generics in the US, the high dependence on Indian generics, and the risk of drug shortages if Indian suppliers exit the market.
The brokerage firm concludes that while the imposition of tariffs is a low-probability event, the potential impact on Indian pharmaceutical companies varies significantly based on their exposure to the US generics market. Overall, the report suggests that investors should focus on companies with diversified portfolios and lower reliance on the US generics market, such as Torrent Pharma, Sun Pharma, and Divi’s Laboratories.
Mumbai-based Zydus Trust makes a luxury flat purchase in Worli for Rs 2 billion.
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.
Indian billionaire Zydus Family Trust acquires luxurious Mumbai apartment worth 200 million rupees, with exclusive details to follow.
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 secures FDA approval in the US for its 60mg Apalutamide Tablets
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’ Gujarat unit gains US FDA clearance following successful inspection
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.
CDSCO’s panel recommends revising the phase III clinical trial protocol for Zydus Healthcare’s co-formulated Empagliflozin and Metoprolol Succinate
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’ Ankleshwar unit secures successful US FDA inspection, adhering to stringent quality standards.
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.
Zydus’ once-daily candidacy Illexcor emfaces a new opportunity to combat Sickle Cell Disease.
Zydus, an Indian pharmaceutical company, has made a significant move in the competitive field of sickle cell disease treatment by acquiring a stake in US-based Illexa, a company developing a once-daily oral treatment for the disease. This acquisition provides Zydus with a foothold in the market, allowing it to piggyback on the promising preclinical results of Illexa’s therapy.
Sickle cell disease is a debilitating genetic disorder that affects millions of people worldwide, with limited treatment options. Global pharmaceutical majors like Novartis, Pfizer, and Novo Nordisk have all attempted to develop treatments for the disease, but with mixed results. Novartis’ Crizalbinemab, for example, showed promise in clinical trials but was ultimately failed to meet its primary endpoint. Pfizer’s P.vo lead candidate did not meet its primary endpoint in a late-stage trial, while Novo Nordisk’s candidate Liso-cel did not demonstrate consistent results across multiple trials.
Illexa’s once-daily oral treatment, on the other hand, has shown promising preclinical results, which could potentially change the treatment landscape for sickle cell disease. Zydus’ acquisition of a stake in Illexa provides the company with a strategic entry point into this high-demand market, allowing it to leverage Illexa’s research and development expertise to potentially bring a new treatment option to market.
The acquisition also reflects Zydus’ growing presence in the global pharmaceutical industry. With a presence in over 40 countries, Zydus has been expanding its presence in the global market through strategic acquisitions and partnerships. The Illexa deal is the latest in a series of moves by the company to diversify its portfolio and increase its global presence.
In summary, Zydus’ acquisition of Illexa provides the company with a foothold in the lucrative sickle cell disease treatment market, backed by promising preclinical results. This strategic move reflects Zydus’ commitment to expanding its presence in the global pharmaceutical industry, and its ability to identify and capitalize on opportunities in high-demand therapeutic areas.