Morepen Laboratories has submitted its first Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (USFDA) 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 the company’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.
The company is targeting 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. Over time, the company aims to explore differentiated formulations, including potential U.S. 505(b)(2) development programs, subject to product-specific studies and regulatory requirements.
Morepen Laboratories is engaged in the manufacturing and sale of APis/ Bulk Drugs, Home Diagnostics, Formulations and OTC products.
