Morepan to file nine drug applications

Mumbai: Domestic pharma major Morepen Labs is planning to file its nine abbreviated new drug applications 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.

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. Morpen will hold a 51-per cent stake in the SPV while Drugmax will hold the remaining 49-per cent stake.

He said his company would file all the ANDAs, which are at various stages of development at present, by 2009. Currently, Morepens 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).

Suri said once the joint venture agreement is signed between the companies, the new entity will be the marketing arm for the US generic operations, and Morepen will undertake the manufacturing of all the products in India as per US FDA guidelines. The SPV will complete all the regulatory approvals and file the abbreviated new drug applications on behalf of Morepen for the entire range of generic drugs, beginning with Loratadine, Morepens blockbuster drug.

Loratadine is the third-largest selling drug in the world. Drugmax will provide the necessary support and know-how for filing for the ANDA, which is required for generic finished dosage form under the US regulatory system. Suri said to cater to the market, Morepen is setting up formulation manufacturing facilities, in accordance with the USFDA guidelines.

It is considered that India offers a low-cost advantage of supplying high-quality generic drug at competitive prices. With a number of generic drugs worth an estimated $83 billion scheduled to go off patent by the year 2005, it provides us immense business opportunity, Suri said. Morepen Labs is moving up the value-chain and this marketing tie-up will act as a bridge between Morepen products and the US market place, further strengthening our bottomline.

He said Morepen Labs has outlined a Rs 50-crore-brand acquisition programme. The company has asked a series of merchant bankers to scout for leading brands, mainly in the cardiovascular and neurology segments in the therapeutic market and some leading brands in gastroentrology and cold-and-cough segments in the over-the-counter market.