Morepen Laboratories submits first ANDA to USFDA for Sitagliptin Tablets

Morepen Laboratories 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 submission extends the Company's established API and 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 GMP systems. It also incorporates bioequivalence strategy, coordination with contract research organizations and integration of development and study data into the regulatory dossier.

These capabilities strengthen Morepen's ability to support specialized CDMO assignments spanning API development, finished dosage formulation and regulatory submission, broadening the scope and complexity of customer programs it can undertake.

Morepen currently estimates 24-36 months from submission to progress towards approval and commercial supply, subject to FDA review, satisfactory completion of applicable formulation facility inspection requirements and applicable patent and exclusivity requirements.