Date:04/10/2005 URL: http://www.thehindubusinessline.com/2005/10/04/stories/2005100404290300.htm

Back Glenmark's Goa plant gets USFDA nod

Our Bureau

Mumbai , Oct. 3

MUMBAI-based Glenmark Pharmaceuticals Ltd has received regulatory approvals from the US Food and Drug Administration (USFDA) for its solid-dosage plant in Goa.

The Goa facility produces formulations or finished dosage forms of medicine for international regulated markets.

The plant has also received regulatory approvals from two other international bodies — Canada's Therapeutics Products Directorate and South Africa's Medicine Control Council, a company note said.

The Glenmark Chief Executive Office and Managing Director, Mr Glenn Saldanha, said the filing of five abbreviated new drug applications in the US from the Goa facility triggered the USFDA inspection. He hoped to receive regulatory approvals for marketing some of these products shortly. The company has filed applications for seven drugs from the Goa facility to be marketed in the US. It plans to file 13 more this financial year, the note said.