Morepen Labs Files First US ANDA for Sitagliptin Tablets in 25mg, 50mg, 100mg Strengths
Gurugram: Morepen Laboratories Limited has submitted its first Abbreviated New Drug Application (ANDA) to the US Food and Drug Administration (USFDA) for Sitagliptin Tablets USP in 25 mg, 50 mg and 100 mg strengths, marking the company's expansion from active pharmaceutical ingredients (API) and contract development and manufacturing (CDMO) capabilities into finished dosage development and regulatory filings.
The Sitagliptin programme brings together formulation development and scale-up, analytical method development and validation, impurity control, stability studies and the manufacture of regulatory batches under Good Manufacturing Practice (GMP) systems.
The programme also incorporates bioequivalence strategy, coordination with contract research organisations (CROs), and integration of development and study data into the regulatory dossier.
According to Morepen, these capabilities strengthen its ability to undertake specialised CDMO assignments spanning API development, finished dosage formulation and regulatory submissions, broadening the scope of customer programmes it can support.
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 U.S. 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 programmes, technology transfer, co-development and licensing opportunities. The company said these capabilities can also support product and dossier development for regulated markets across Europe and Asia, tailored to the requirements of individual jurisdictions.
Over time, the company aims to explore differentiated formulations, including potential US 505(b)(2) development programmes, subject to product-specific studies and 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 US$1.604 billion in 2025, according to the company.
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, the company said.
Morepen currently estimates a period of 24–36 months from submission to progress towards approval and commercial supply, subject to USFDA review, satisfactory completion of applicable formulation facility inspection requirements, and applicable patent and exclusivity requirements.
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 global pharmaceutical customers.
