Glenmark receives FDA approval for Moexipril Hydrochloride tablets

Glenmark Pharmaceuticals said today that its American subsidiary has received the US Food and Drug Administration's (FDA) final approval for Moexipril Hydrochloride tablets, which is used in the treatment of hypertension.

The FDA has granted final approval for the tablets to the company's group firm Glenmark Generics Inc, the company said in a statement to the National Stock Exchange.
The tablets are generic versions of Schwarz Pharma's Uniretic and, according to Glenmark, the product is currently available and will start shipping immediately.

Moexipril Hydrochloride belongs to a class of drugs called ACE inhibitors. The product in combination with Glenmark's diuretic hydrochlorothiazide is indicated in the treatment of hypertension. According to IMS Health, total US sales of the combination during the 12 month period ending December 2009 were $8 million.

Today's approval follows close on the heels of Glenmark's announcement of final ANDA approval for Ropinirole Hydrochloride tablets, the generic version of GSK's Requip tablets. The company has recently launched Ropinirole Hydrochloride tablets in the US market.

Glenmark is currently authorised to distribute 51 products in the US. It has nearly 98 ANDAs filed or marketed in the US and continues to gain strength from its internal pipeline projects as also through partnerships to augment the breadth of its portfolio.