Glenmark Generics Ltd (GGL), a subsidiary of Glenmark Pharmaceuticals Ltd. has received ANDA approval from the US FDA for trandolapril tablets USP 1 mg, 2 mg and 4 mg and will immediately commence marketing and distribution of these products in the US market.
Trandolapril is an ACE (Angiotensin Converting Enzyme) inhibitor used to treat high blood pressure and is 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 US $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 per cent, Mometasone Ointment USP 0.1 per cent and metformin tablets USP 500 mg, 850 mg, 1000 mg brings GGL's current portfolio to 33 generic products authorized for distribution in the US market. The company currently has over 35 ANDA's filed with the US FDA pending approval.