Morepen Laboratories Ltd has submitted its first Abbreviated New Drug Application (ANDA) to the US Food and Drug Administration (US FDA) for Sitagliptin Tablets USP in strengths of 25 mg, 50 mg and 100 mg.

The filing marks an expansion of the company’s existing API and CDMO capabilities into finished dosage development and regulatory submissions.

The Sitagliptin programme covers formulation development and scale-up, analytical method development and validation, impurity control, stability studies and manufacturing of regulatory batches under GMP systems. It also includes bioequivalence strategy, coordination with contract research organisations and integration of development data into the regulatory dossier.

Morepen said the expanded capabilities will enable it to undertake more specialised CDMO assignments spanning API development, finished dosage formulation and regulatory submissions, while broadening the scope of customer development programmes.

Managing Director Sanjay Suri said the company’s first ANDA submission brings together its scientific, manufacturing and regulatory capabilities to take an API through finished dosage development to a US filing.

Sitagliptin is an established oral treatment for Type 2 diabetes and belongs to the DPP-4 inhibitor class of medicines. Morepen currently estimates 24–36 months from submission towards approval and commercial supply, subject to US FDA review, applicable facility inspections and patent and exclusivity requirements.

The company plans to build on the milestone through customer development programmes, technology transfers, co-development and licensing opportunities, while also exploring differentiated formulations and potential US 505(b)(2) development programmes.