Morepen Laboratories has submitted its first Abbreviated New Drug Application (ANDA) to the US Food and Drug Administration for Sitagliptin Tablets USP in 25 mg, 50 mg and 100 mg strengths. The submission extends the company’s established API and CDMO expertise into integrated finished dosage development and regulatory filing.
The Sitagliptin program brings together formulation development and scale-up, analytical method development and validation, impurity control, stability studies and manufacture of regulatory batches under GMP systems. It also incorporates bioequivalence strategy, coordination with contract research organizations and integration of development and study data into the regulatory dossier.
These capabilities strengthen Morepen’s ability to support specialized CDMO assignments spanning API development, finished dosage formulation and regulatory submission, broadening the scope and complexity of customer programs it can undertake.
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,”
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 programs, technology transfer, co-development and licensing opportunities. These capabilities can also support product and dossier development for regulated markets across Europe and Asia, tailored to each jurisdiction’s requirements.
Over time, the Company aims to explore differentiated formulations, including potential US 505(b)(2) development programs, subject to product-specific studies and regulatory requirements.
Sitagliptin is an established oral treatment for adults with Type 2 diabetes, belonging to the DPP 4 inhibitor class, commonly known as gliptins. Its innovator product, Januvia, recorded worldwide sales of approximately US$1.604 billion in 2025. The relevant US phosphate salt patent is scheduled to expire in November 2026, with associated paediatric exclusivity extending to May 2027; certain manufacturers have separate arrangements permitting earlier entry.
Morepen currently estimates 24–36 months from submission to progress towards approval and commercial supply, subject to FDA review, satisfactory completion of applicable formulation facility inspection requirements and applicable patent and exclusivity requirements.