Morepen Laboratories 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 submission extends the company’s established Active Pharmaceutical Ingredients (API) and Contract Development and Manufacturing Organisation (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 Good Manufacturing Practice (GMP) systems. It also incorporates bioequivalence strategy, coordination with Contract Research Organisations (CROs) and integration of development and study data into the regulatory dossier.

These capabilities strengthen Morepen’s ability to support specialised 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, 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.

“Alongside our planned Innovation Hub and investments in advanced chemistry and technology, this milestone strengthens our ability to undertake specialised CDMO assignments and build long-term development partnerships,” Suri further added.

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.