Domestic pharma major Morepen Labs is planning to file its nine abbreviated new drug applications (ANDA) with the US FDA by the year 2003. The company would file its first two ANDAs - Loratadine (anthistatminic drug) and Atorvastain Calcium (anti-cholesterol) - by the end of 2002. Loratadine is the third-largest selling drug in the world.
Currently, Morepen's ANDAs pipeline has Loratadine, Fexofenadine Hydrochloride (antihistaminic), Atrovastain Calcium, Fluvastain Sodium (anti-cholesterol), Zafirlukast (antiasthamatic), Cisapride BP (gastro pro-kinetic), Sultamicillin Tosylate (anti-bacterial), Sultamicillin Base (anti-bacterial) and Sulbactam Sodium (anti-bacterial).
Morepen Labs CMD Sushil Suri said his company will file the ANDAs through its new joint venture subsidiary with the US-based Drugmax Inc. Recently, Morepen Labs had floated a special-purpose vehicle in joint venture with Drugmax to tap the $200-billion US generic market.
Drugmax provides the necessary support and guides how to file for the ANDA, which is required for generic finished dosage form under the US regulatory system. Morepen is setting up formulation manufacturing facilities, in accordance with the USFDA guidelines.