New Delhi: Glenmark Pharmaceuticals on Thursday said its subsidiary Glenmark Generics Inc has received final approval from the US health regulator for Verapamil tablets, which are used for treating hypertension.
“Today’s approval completes Glenmark’s marketing portfolio for the Verapamil extended-release product line,” Glenmark said in a statement.
The US Food and Drug Administration (USFDA) approval is for Verapamil extended release tablets in the strengths of 120 mg and 180 mg. The company had earlier received approval on the 240 mg dosage in September 2009, Glenmark said.
Verapamil extended-release tablets are generics of Isoptin SR tablets of Ranbaxy.
“Verapamil extended release tablets are indicated in the management of essential hypertension and for the 12 month period ending March 2011 achieved sales of $52 million, according to IMS Health,” it added.
The company has 72 generic products authorised for distribution in the US market and has over 35 ANDA’s filed with the USFDA which are pending approval.
Shares of Glenmark were trading at Rs338.40 in afternoon trade on the Bombay Stock Exchange (BSE), up 2.58% from its previous close.