The US Food and Drug Administration (USFDA) has announced a recall of over 17,000 units of antifungal shampoo, Ciclopirox Shampoo, due to manufacturing issues. The recall was initiated by Taro Pharmaceutical Industries, the US arm of Sun Pharma, on December 9. The shampoo is used to treat seborrheic dermatitis, a condition that causes dry, flaky, and itchy skin. The recall was classified as a Class II recall, which means that the product’s use may lead to temporary or medically reversible health consequences, but the likelihood of serious adverse health outcomes is minimal.

The recall was due to “failed impurity/degradation specifications,” according to the USFDA. Taro Pharmaceutical Industries is a private company and a wholly-owned subsidiary of Sun Pharma, which acquired the Israel-based company in a deal valued at $347.73 million last year. Sun Pharma has been the majority shareholder of Taro since 2010. Taro primarily focuses on dermatology and produces a wide range of prescription and over-the-counter products.

The recall is a setback for Sun Pharma, which is a leading exporter to the US market. In the second quarter of FY26, the company reported revenue of Rs 14,478 crore, with a net profit of Rs 3,118 crore, a 2.56% increase year-on-year. However, formulation sales in the US declined 4.1% to $496 million. The recall highlights the importance of quality control and regulatory compliance in the pharmaceutical industry.

The USFDA’s Enforcement Report noted that the recall was nationwide and affected 17,664 units of the Ciclopirox Shampoo. The company has taken prompt action to address the issue, and the recall is expected to minimize any potential harm to consumers. The incident serves as a reminder of the need for pharmaceutical companies to maintain high standards of quality and manufacturing practices to ensure the safety and efficacy of their products.

The Delhi High Court has ruled that a lawsuit filed by Sun Pharmaceutical Industries against a company selling a product called “PEPFIX-NEOVITAL” is maintainable. The court’s decision was based on the fact that the defendant company has an online presence, which suggests that it is doing business in the Delhi territory.

The lawsuit was filed by Sun Pharma, which claimed that the defendant company was infringing on its trademark by selling a product with a similar name. The defendant company had argued that the court did not have jurisdiction to hear the case, as it was not doing business in Delhi.

However, the court rejected this argument, citing the fact that the defendant company has a website and is selling its products online. The court noted that the website is accessible to customers in Delhi, and that the defendant company is therefore doing business in the territory.

The court’s decision is significant, as it highlights the importance of online presence in determining jurisdiction in intellectual property cases. The ruling suggests that companies with an online presence can be considered to be doing business in a particular territory, even if they do not have a physical presence there.

The case is also notable for its implications for trademark law in India. The court’s decision suggests that companies must be careful to ensure that their online activities do not infringe on the trademarks of other companies. The ruling also highlights the need for companies to be aware of their online presence and to take steps to protect their intellectual property rights in the digital sphere.

In its ruling, the court noted that the defendant company’s website is accessible to customers in Delhi, and that the company is therefore subject to the jurisdiction of the Delhi High Court. The court also noted that the defendant company’s online activities are sufficient to establish a “commercial connection” with the territory, which is a requirement for establishing jurisdiction.

Overall, the Delhi High Court’s ruling in the PEPFIX-NEOVITAL case is an important development in the field of intellectual property law in India. The decision highlights the importance of online presence in determining jurisdiction and the need for companies to be aware of their online activities and to take steps to protect their intellectual property rights.

Sun Pharmaceutical Industries Ltd. has received approval from the US Food and Drug Administration (USFDA) for an updated label for its medication UNLOXCYT (tretinoin), which is used to treat a rare skin condition called Cutaneous Squamous Cell Carcinoma (CSCC) in patients with advanced renal cell carcinoma (RCC). The updated label includes long-term efficacy data, demonstrating the treatment’s effectiveness in preventing the progression of CSCC.

UNLOXCYT is a topical formulation of tretinoin, a retinoid that has been shown to inhibit the growth of cancer cells. The medication is specifically designed to treat CSCC, a type of skin cancer that can occur in patients with advanced RCC. The condition is often aggressive and can lead to significant morbidity and mortality if left untreated.

The updated label includes data from a long-term study that evaluated the efficacy of UNLOXCYT in preventing the progression of CSCC in patients with advanced RCC. The study demonstrated that treatment with UNLOXCYT significantly reduced the risk of CSCC progression compared to placebo. The data also showed that UNLOXCYT was well-tolerated, with a safety profile consistent with previous studies.

The approval of the updated label is a significant milestone for Sun Pharma, as it provides healthcare providers with additional confidence in the long-term efficacy of UNLOXCYT in treating CSCC. The company believes that the updated label will help to increase awareness and adoption of the medication among healthcare providers and patients.

The USFDA approval is also a testament to Sun Pharma’s commitment to developing innovative treatments for rare and debilitating diseases. The company has a strong portfolio of specialty and generic products, and is dedicated to improving the lives of patients around the world.

In a statement, a spokesperson for Sun Pharma said, “We are pleased to receive USFDA approval for the updated UNLOXCYT label, which includes long-term efficacy data demonstrating the treatment’s effectiveness in preventing the progression of CSCC. This approval is a significant milestone for our company, and we believe it will help to increase awareness and adoption of UNLOXCYT among healthcare providers and patients.” The updated label is expected to be available in the US market shortly.

Sun Pharmaceutical Industries, one of India’s largest pharmaceutical companies, has won a significant excise refund battle. The Customs, Excise, and Service Tax Appellate Tribunal (CESTAT) ruled in favor of Sun Pharma, dismissing a revenue demand of Rs 828 crore (approximately $112 million USD) as “legally unsustainable.” The tribunal’s decision is a major victory for the company, which had been embroiled in a long-standing dispute with the excise authorities.

At the heart of the dispute was the issue of excise duty refund claims filed by Sun Pharma for the period between 2007 and 2012. The company had claimed a refund of excise duty paid on certain products, which were later exempted from excise duty. However, the excise authorities had rejected the claims, citing various grounds, including alleged suppression of facts and misdeclaration of goods.

The CESTAT, however, found that the revenue demand raised by the excise authorities was not sustainable in law. The tribunal observed that the excise authorities had failed to follow the principles of natural justice and had not provided adequate opportunities to Sun Pharma to respond to the allegations. Furthermore, the CESTAT noted that the excise authorities had not demonstrated any suppression of facts or misdeclaration of goods by Sun Pharma.

The ruling is significant not only for Sun Pharma but also for the entire pharmaceutical industry. The decision sets a precedent for other companies that may be facing similar disputes with the excise authorities. It also highlights the importance of following the principles of natural justice and ensuring that companies are given adequate opportunities to respond to allegations.

The Rs 828 crore refund claim is a substantial amount, and the ruling is expected to provide a significant boost to Sun Pharma’s financials. The company can now claim a refund of the excise duty paid, which will help to improve its cash flows and profitability. The decision also demonstrates the effectiveness of the judicial system in resolving disputes between companies and the government.

In conclusion, the CESTAT’s ruling in favor of Sun Pharma is a major victory for the company and a significant development for the pharmaceutical industry. The decision highlights the importance of following the principles of natural justice and ensuring that companies are given adequate opportunities to respond to allegations. With the Rs 828 crore refund claim now cleared, Sun Pharma can focus on its business operations and growth plans, without the burden of a long-standing dispute with the excise authorities.

Sun Pharmaceutical Industries Ltd. has reported a significant shift in its business mix, with innovative medicines outpacing generic drug sales in the United States during the second quarter of fiscal year 2026. The company’s innovative medicines, including Ilumya, Cequa, and Odomzo, drove strong demand and growth. The recent launch of Leqselvi, a newly approved alopecia treatment, has further accelerated this growth. Leqselvi was acquired through Sun Pharma’s $576 million purchase of Concert Pharma and has been well received in the US market.

The company’s global innovative drug revenue reached $333 million in Q2FY26, up 16.4% year-over-year, accounting for 20.2% of total consolidated revenue. For the first half of FY26, innovative drug sales totaled $644 million, growing 16.6% year-over-year. Sun Pharma’s CEO, Richard Ascroft, noted that sales of innovative medicines will continue to rise as the company prepares to launch its cancer immunotherapy, Unloxcyt.

The company’s executive chairman, Dilip Shanghvi, reaffirmed the company’s focus on expanding its R&D pipeline and is awaiting updated FDA labeling approval for Unloxcyt ahead of its planned US launch in the second half of FY26. This shift towards innovative and specialty medicines is expected to strengthen the company’s margins and enhance market differentiation, securing long-term growth in the US and global pharmaceutical markets.

Sun Pharma’s strategic move towards innovative medicines is a significant development, as it positions the company for sustained growth and profitability. The company’s investment in R&D and its pipeline of new products, including Unloxcyt, are expected to drive future growth. With the pharmaceutical industry increasingly shifting towards innovative and specialty medicines, Sun Pharma’s strategy is well-aligned with industry trends. Overall, the company’s Q2FY26 results indicate a positive outlook for its innovative medicines business, and investors will be watching the company’s progress closely in the coming quarters.