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Morepen Labs Files First US FDA ANDA for Diabetes Drug
28 Sep
Summary
- Morepen Labs submitted its first ANDA to the US FDA for sitagliptin tablets.
- This filing marks Morepen's entry into integrated finished-dose development.
- Sitagliptin is a DPP-4 inhibitor used for type 2 diabetes treatment.
Morepen Laboratories recently achieved a significant milestone by submitting its first Abbreviated New Drug Application (ANDA) to the US Food and Drug Administration (FDA). The application pertains to sitagliptin tablets in various strengths, a medication crucial for managing type 2 diabetes. This submission represents Morepen's strategic expansion into integrated finished-dose development, encompassing formulation and regulatory filings.
This initiative builds upon Morepen's established expertise in active pharmaceutical ingredients (API) and contract development and manufacturing organisation (CDMO) services. The company's capabilities now extend to formulation development, bioequivalence studies, and regulatory batch manufacturing. The patent for the relevant US sitagliptin phosphate salt is set to expire in November 2026, with an associated paediatric exclusivity ending in May 2027.
Sanjay Suri, managing director of Morepen Laboratories, highlighted that this filing integrates the necessary scientific, manufacturing, and regulatory skills for a US filing. He anticipates a 24-36 month period from submission to potential approval and commercial supply. The company aims to leverage this enhanced capability for specialized CDMO assignments and foster long-term development partnerships.
