Morepen Laboratories Ltd submitted its first Abbreviated New Drug Application (ANDA) to the US Food and Drug Administration on September 25, 2026, for Sitagliptin Tablets USP in three dosage strengths, 25 mg, 50 mg, and 100 mg. The filing marks the Indian pharmaceutical company’s entry into finished dosage regulatory submissions for the US market.
Sitagliptin is a Type 2 diabetes treatment belonging to the DPP-4 inhibitor class. Its branded version, Januvia, marketed by Merck, recorded global sales of approximately $1.604 billion in 2025. The relevant US phosphate salt patent is set to expire in November 2026, with paediatric exclusivity running through May 2027, though certain manufacturers hold earlier-entry arrangements.
Morepen estimates a 24 to 36-month timeline from submission to potential approval and commercial supply, subject to FDA review, facility inspection, and patent clearance. The ANDA number assigned is 221758. The company clarified that submission does not constitute FDA acceptance or product approval.
The Sitagliptin program involved formulation development, analytical method validation, impurity control, stability studies, bioequivalence strategy, and coordination with contract research organisations, capabilities the company says strengthen its contract development and manufacturing organisation (CDMO) offering.
Managing Director Sanjay Suri described the submission as a capability-building milestone, stating it brings together the scientific, manufacturing, and regulatory skills needed to take an API through to a US regulatory filing.
Morepen trades on NSE at ₹122.00, up 1.35 per cent on Monday, with a market capitalisation of approximately ₹6,683 crore. The stock has gained nearly 196 per cent year-to-date and trades at a trailing P/E of 46.94.
Published on September 28, 2026
