The submission extends Morepen’s established expertise in active pharmaceutical ingredients (APIs) and contract development and manufacturing organisation (CDMO) services into finished dosage formulation, bioequivalence and regulatory dossier preparation.
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. It also includes bioequivalence strategy, coordination with contract research organisations and the integration of development and study data into the regulatory dossier.
These capabilities are expected to strengthen Morepen’s ability to undertake specialised CDMO assignments covering API development, finished dosage formulation and regulatory submissions. The expanded scope could enable the company to handle more complex customer programmes and support integrated pharmaceutical development requirements.
Mr. Sanjay Suri, Managing Director of 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 U.S. filing,”
Mr. Suri further 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 intends to build on this foundation through customer development programmes, technology transfer, co-development and licensing opportunities. The company also plans to leverage these capabilities for product and dossier development in regulated markets across Europe and Asia, with each programme tailored to the requirements of the respective jurisdiction.
Over time, Morepen aims to explore differentiated formulations, including potential U.S. 505(b)(2) development programmes. These initiatives would remain subject to product-specific studies and applicable regulatory requirements.
Sitagliptin is an established oral treatment for adults with Type 2 diabetes and belongs to the DPP-4 inhibitor class, commonly known as gliptins. Its innovator product, Januvia, recorded worldwide sales of approximately USD 1.604 billion in 2025, according to Merck’s 2025 Annual Report. This figure represents historical sales of the innovator product, rather than the total generic market or a forecast of potential revenue for Morepen.
The relevant U.S. sitagliptin phosphate salt patent is scheduled to expire on 24th November 2026, with associated paediatric exclusivity extending to 24th May 2027. However, settlement arrangements permit certain manufacturers to enter the market earlier.
According to the company, ANDA No. 221758 was submitted on 25th September 2026. The submission does not constitute FDA acceptance for substantive review, product approval or authorisation for commercial supply in the United States.
Morepen currently estimates a period of 24–36 months from submission to progress towards approval and commercial supply. This timeline remains subject to FDA review, satisfactory completion of applicable formulation facility inspection requirements, and compliance with relevant patent and exclusivity requirements.
The company’s expansion into integrated finished dosage development builds on its existing API expertise while adding formulation, bioequivalence and regulatory filing capabilities. Potential opportunities across regulated markets and future 505(b)(2) programmes will depend on the supporting data, jurisdiction-specific submissions and approvals required for each product.
Morepen Laboratories Limited (NSE: MOREPENLAB; BSE: 500288) is an Indian pharmaceutical company with established 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 long-term partnerships with global pharmaceutical customers.
The company’s forward-looking statements cover development plans, proposed capabilities, potential partnerships, regulatory timelines and commercialisation. These statements reflect current expectations and are subject to risks and uncertainties, including regulatory outcomes, facility inspections, development results, intellectual property requirements and market conditions. Actual outcomes may differ materially, and the company undertakes no obligation to update these statements except as required by applicable law.
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