Aug 24, 2009

Ranbaxy Laboratories receives final approval from USFDA

Ranbaxy Laboratories (RLL) has announced that the company has received approval from the U.S. Food and Drug Administration to manufacture and market Glycopyrrolate Tablets USP, 1 mg and 2 mg. The office of Generic Drugs, U.S. Food and Drug Administration has determined the Ranbaxy formulations to be bioequivalent and have the same therapeutic effect as that of the reference listed drug Robinul 1 mg and Robinul Forte Tablets, 2 mg, respectively, of Sciele Pharma, Inc. The total annual market sales for Glyeopyrrolate Tablets were $26 million. Glycopyrrolate Tablets are indicated for use as adjunctive therapy in the treatment of peptic ulcer.

Ranbaxy Pharmaceuticals (RPI), based in Jacksonville, Florida, USA, is a wholly owned subsidiary of Ranbaxy Laboratories (RLL), India`s largest pharmaceutical company. RPI is engaged in the sale and distribution of generic and branded prescription products in the U.S. healthcare system.

No comments:

.