Glenmark Pharmaceuticals has received US FDA approval for its Ankhleshwar plant that manufactures Active Pharmaceutical Ingredients (APIs). The facility was inspected in May 2004 for two of its DMFs, Amiodarone and Cilastazol, which were filed in the second half of FY 2004.
The company has already filed four DMFs from the facility till date including the two approved products. Going forward, the company expects to file another 8-10 DMFs from the Ankhleshwar facility in this financial year. Supplies of the two APIs to clients in the US are expected to commence later this year, a company release said.
The Ankhleshwar facility was acquired in 2001 from Glaxo SmithKline (GSK) and has since then been upgraded to meet the strict US FDA standards. Glenn Saldanha, managing director and CEO of Glenmark said, "These approvals will help us build on and sustain the growth delivered by the API business in the first quarter of this year by tapping the more profitable regulated markets."
The company has already announced a tie-up with three players in North America - Apotex, Eon Labs and KV Pharmaceuticals for the supply of API.