India, Sept. 28 -- 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 sa...