Morepen Labs Submits First US ANDA for Sitagliptin Tablets

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.