- Morepen Laboratories Limited has submitted its first Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration for Sitagliptin Tablets USP in 25 mg, 50 mg and 100 mg strengths.
- The program expands Morepen’s API and CDMO capabilities into finished dosage development, regulatory filing, analytical development, GMP manufacturing and related regulatory activities.
Morepen Laboratories Limited has submitted its first Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) 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 combines formulation development and scale-up, analytical method development and validation, impurity control, stability studies and manufacture of regulatory batches under GMP systems. It also includes a bioequivalence strategy, coordination with contract research organizations and integration of development and study data into the regulatory dossier.
According to Morepen, these capabilities strengthen its ability to undertake specialized CDMO assignments spanning API development, finished dosage formulation and regulatory submission. The company said this broadens the scope and complexity of customer programs it can support.
“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,” said Sanjay Suri, Managing Director of Morepen Laboratories Limited.
Morepen said it plans to build on this foundation through customer development programs, technology transfer, co-development and licensing opportunities. The company also said these capabilities can support product and dossier development for regulated markets across Europe and Asia, tailored to individual jurisdictional requirements. Over time, it aims to explore differentiated formulations, including potential U.S. 505(b)(2) development programs, subject to product-specific studies and regulatory requirements. The company currently estimates 24–36 months from submission to progress toward approval and commercial supply, subject to FDA review and satisfactory completion of applicable requirements.
