Morepen Laboratories has filed its first Abbreviated New Drug Application with the US Food and Drug Administration, the company announced on Sept 28. The filing covers Sitagliptin Tablets USP in 25 mg, 50 mg and 100 mg strengths.

Sitagliptin is a diabetes medicine in the DPP-4 inhibitor class. Managing Director Sanjay Suri said the filing is central to Morepen's next phase of growth, bringing together the scientific, manufacturing and regulatory skills needed to take an API through finished-dosage development to a US filing.

The programme spanned formulation development and scale-up, analytical method development and validation, impurity control, stability studies, GMP manufacture of regulatory batches, bioequivalence strategy and CRO coordination. The company says these capabilities strengthen its integrated CDMO offering across API development, finished-dosage formulation and regulatory submission.

Morepen expects the platform to support customer programmes, technology transfer, co-development and licensing in regulated markets across Europe and Asia. The announcement was made through a company-sourced NewsVoir release, so the company's next regulatory milestones will confirm how quickly the filing progresses.