Live Events

Granules India Limited has submitted an Abbreviated New Drug Application (ANDA) for Ruxolitinib Extended-Release Tablets with a Paragraph IV certification. The company believes it is eligible for first-to-file status, which could grant 180 days of generic drug exclusivity in the U.S. if confirmed by the FDA. This strategic move aligns with Granules India's objective to enhance its U.S. product portfolio with higher-value generics. The ANDA is subject to FDA review, and the company will provide further updates as required. This filing represents a significant step in their U.S. market strategy, focusing on technically and commercially attractive opportunities.

Aurobindo Pharma Limited announced it has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Perampanel Tablets in various dosages (2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg). These tablets are bioequivalent and therapeutically equivalent to Catalyst Pharmaceuticals' Fycompa® Tablets. The product will be manufactured at Aurobindo's wholly-owned subsidiary, APL Healthcare's Unit-IV, and is slated for launch in Q3FY27. The approved product targets an estimated market size of US$ 67 million. This approval adds to Aurobindo's portfolio, bringing their total USFDA ANDA approvals to 599 (574 final, 25 tentative). Perampanel Tablets are indicated for epilepsy treatment.

Godavari Biorefineries Ltd has announced that the Mexican Patent Office has granted its patent application titled 'Use of Compounds for Treating Viral Infections'. The patent pertains to the use of specific compounds for inhibiting V-ATPase activity, with applications in the manufacture of medicaments for treating viral infections. This grant, effective from September 15, 2026, provides protection for twenty years, expiring on May 10, 2041. The invention was originally filed internationally on May 10, 2021, with priority from an Indian application dated May 11, 2020. This intellectual property strengthens the company's position in the biopharmaceutical sector.

Sun Pharmaceutical Industries Limited announced that its drug LEQSELVI® (deuruxolitinib) demonstrated sustained efficacy and safety over two years in severe alopecia areata (AA) patients. Data presented at the European Academy of Dermatology and Venereology (EADV) Congress 2026 showed a consistent safety profile with generally mild to moderate adverse events, and no deaths, thrombosis, or major cardiovascular events reported at the FDA-approved dose. Long-term efficacy analyses indicated durable scalp hair regrowth, with a high percentage of patients maintaining response. These findings reinforce LEQSELVI®'s potential as a long-term treatment option for severe AA.

Jeevan Scientific Technology Ltd announced the successful closure of its United States Food and Drug Administration (US FDA) inspection for its Bioanalytical Facility in Manikonda, Hyderabad. The inspection, conducted from July 20-24, 2026, concluded with zero observations (no 483s). The company received the Establishment Inspection Report (EIR) on September 30, 2026, confirming the successful conclusion of the inspection under 21 CFR 20.64(d)(3). This positive outcome is a significant regulatory milestone for the company.

Symbiotec Pharmalab Limited has received the Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (U.S. FDA) for its manufacturing facility located in Pithampur, Madhya Pradesh, India. The facility was classified with a Voluntary Action Indicated (VAI) status following the inspection, which took place from August 10 to August 14, 2026. This VAI classification indicates that while some issues may have been noted, they do not currently warrant significant regulatory action, suggesting the facility meets acceptable standards for U.S. FDA compliance. This development is positive for the company's export capabilities and market access to the United States.

Zydus Lifesciences announced the conclusion of a USFDA cGMP inspection at its manufacturing plant in SEZ II, Ahmedabad. The inspection, conducted from September 21st to 28th, 2026, resulted in a single observation. Importantly, there were no data integrity-related observations. The company stated it will work closely with the USFDA to address the observation promptly. This disclosure is made pursuant to SEBI regulations.

Lupin Limited has received tentative approval from the U.S. Food and Drug Administration (FDA) for its New Drug Application for Apixaban Oral Suspension 1.25mg/mL, developed via the 505(b)(2) pathway. This oral liquid formulation is an alternative administration option for adult patients requiring anticoagulation therapy, particularly those who have difficulty swallowing tablets. The active ingredient is apixaban, the same as in Eliquis® by Bristol Myers Squibb. Upon final approval, the product will be manufactured at Lupin's Somerset, New Jersey facility. This development aligns with Lupin's strategy to focus on differentiated medicines addressing patient needs and expanding its therapeutic portfolio.

Morepen Laboratories Limited has submitted its first Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration for Sitagliptin Tablets USP in 25 mg, 50 mg, and 100 mg strengths. This submission marks a significant step in expanding the company's integrated Contract Development and Manufacturing Organization (CDMO) capabilities, moving beyond API to finished dosage development and regulatory filing. The Sitagliptin program encompasses formulation development, scale-up, analytical method validation, stability studies, and GMP manufacturing. This strengthens Morepen's ability to undertake specialized CDMO assignments for regulated markets, including Europe and Asia. The company anticipates a 24-36 month timeline to potential approval and commercial supply, subject to FDA review and other regulatory requirements. Sitagliptin is a treatment for Type 2 diabetes, with its innovator product having recorded substantial sales.

Unichem Laboratories Ltd announced that its Goa formulation facility underwent an inspection by the United States Food and Drug Administration (USFDA) from September 21st to September 26th, 2026. The inspection concluded with five observations, primarily related to procedural enhancements. The company is committed to providing a comprehensive response to the USFDA within the stipulated 15-day period. This development is a routine regulatory process for pharmaceutical facilities operating internationally.