Morepen Laboratories Limited has submitted its first Abbreviated New Drug Application (ANDA) to the US Food and Drug Administration (FDA) for Sitagliptin Tablets USP in 25 mg, 50 mg and 100 mg strengths. The filing marks an expansion of Morepen’s established active pharmaceutical ingredient (API) and contract development and manufacturing organisation (CDMO) capabilities into finished dosage development and regulatory submissions for the U.S. market.
The Sitagliptin programme combines formulation development and scale-up with analytical method development and validation, impurity control, stability studies and the manufacture of regulatory batches under Good Manufacturing Practice (GMP) systems. The programme also includes bioequivalence strategy, coordination with contract research organisations and consolidation of development and study data into the regulatory dossier.
Sanjay Suri, Managing Director, Morepen Laboratories Limited, said: “Capability building is central to Morepen’s next phase of growth. Our first ANDA submission brings together the scientific, manufacturing and regulatory skills needed to take an API through finished dosage development to a US filing.” Mr Suri added: “Alongside our planned Innovation Hub and investments in advanced chemistry and technology, this milestone strengthens our ability to undertake specialized CDMO assignments and build long-term development partnerships.”
Morepen said the capabilities developed through the Sitagliptin programme can support future customer programmes involving API development, finished dosage formulation, technology transfer, co-development and licensing. The company also intends to use these capabilities for product and dossier development for regulated markets in Europe and Asia, subject to individual market requirements.
The company plans to build on its finished dosage and regulatory capabilities through customer development programmes and specialised CDMO assignments. It also intends to explore differentiated formulations, including potential U.S. 505(b)(2) development programmes, subject to product-specific studies and regulatory requirements.
Sitagliptin is an oral treatment for adults with Type 2 diabetes and belongs to the dipeptidyl peptidase-4 (DPP-4) inhibitor class. The innovator product, Januvia, recorded worldwide sales of approximately US$1.604 billion in 2025. Morepen said the relevant US phosphate salt patent is scheduled to expire in November 2026, with associated paediatric exclusivity extending to May 2027. The company noted that certain manufacturers have separate arrangements permitting earlier market entry.
Morepen currently estimates 24–36 months from submission to progress towards approval and commercial supply, subject to FDA review, completion of applicable formulation facility inspection requirements and relevant patent and exclusivity requirements. The ANDA submission adds a regulatory development capability to Morepen’s existing API and manufacturing operations. The company is seeking to expand its role in pharmaceutical development by integrating scientific, manufacturing and regulatory capabilities under its CDMO activities.
Morepen Laboratories Limited (NSE: MOREPENLAB; BSE: 500288) is an Indian pharmaceutical company with expertise in active pharmaceutical ingredients and a growing focus on contract development and manufacturing. The company is expanding its scientific, manufacturing and regulatory capabilities to support integrated development programmes and partnerships with pharmaceutical customers.
