CNN Central News & Network-ITDC India Epress/ITDC News Bhopal: Morepen Laboratories Limited has submitted its first Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) for Sitagliptin Tablets USP, marking an important step in the company’s expansion into finished dosage development and integrated contract development and manufacturing organisation (CDMO) capabilities.
The application covers Sitagliptin Tablets in 25 mg, 50 mg and 100 mg strengths. The submission represents Morepen’s move beyond its established Active Pharmaceutical Ingredient (API) capabilities toward an integrated model covering formulation development, manufacturing and regulatory submissions for finished pharmaceutical products.
The Sitagliptin programme includes formulation development and scale-up, analytical method development and validation, impurity control, stability studies and the manufacture of regulatory batches under Good Manufacturing Practice (GMP) systems. The programme also incorporates a bioequivalence strategy, coordination with contract research organisations and integration of development and study data into the regulatory dossier.
Morepen has an established presence in the global pharmaceutical sector, with capabilities spanning APIs, finished formulations and healthcare products. The company says it exports to more than 80 countries and operates facilities with certifications from regulatory authorities including the U.S. FDA, WHO GMP and EU GMP.
The ANDA submission is subject to the U.S. FDA’s regulatory review process and does not itself constitute approval or commercial marketing authorization. The development is expected to strengthen Morepen’s capabilities in formulation development and regulatory filing while supporting its broader strategy of expanding integrated CDMO services.
Hashtags: #BusinessEconomy #Bhopal #Desksource #Morepen #Files #First #DeskSource #Anda #Sitagliptin #Tablets
