Glenmark Generics Ltd (GGL) a subsidiary of Glenmark Pharmaceuticals Ltd (Glenmark), has received ANDA approval from the United States Food and Drug Administration (U.S. FDA) for Trandolapril tablets USP 1 mg, 2 mg and 4 mg and will immediately commence marketing and distribution of these products in the U.S. market.
Trandolapril is an ACE (Angiotensin Converting Enzyme) inhibitor used to treat high blood pressure and a the generic equivalent of Mavik tablets marketed by Abbott Laboratories.
The total sales for Trandolapril tablets in the twelve month period ending March 2008 were in excess of USD 23 million, as per IMS Health. This recent approval coupled with the three ANDA approvals received from the US FDA in May 2008 for Mometasone Cream USP 0.1%, Mometasone Ointment USP 0.1% and Metformin Tablets USP 500 mg, 850 mg, 1000 mg brings GGL's current portfolio to 33 generic products authorized for distribution in the U.S. market. The Company currently has over 35 ANDA'S filed with the U.S. FDA pending approval.
|
