Ipca Laboratories - Ranbaxy alliance receive US FDA marketing approval for Hydrochlorothiazide Tablets

Ipca Laboratories Ltd has announced that the Company had earlier announced strategic alliance with Ranbaxy Pharmaceuticals Inc, (Ranbaxy) based in Jacksonville, Florida (USA), a wholly owned subsidiary of Ranbaxy Laboratories Ltd. (RLL), India's largest pharmaceutical Company.

Under the strategic alliance, Ohm Laboratories, Inc. (Ohm), wholly owned subsidiary of RLL has now received approval from U.S. Food and Drugs Administration to manufacture and market Hydrochlorothiazide Tablets USP 12.5mg, 25mg and 50mg in the US market. Total annual market sales for Hydrochlorothiazide tablets in U.S. were US $ 30.8 million (IMS-MAT:March 2007). This is the fourth such product approval received under the alliance from U.S. FDA.

Initially, Ohm will manufacture and Ranbaxy will market this formulation in the US healthcare system using the Company's DMF approved Active Pharmaceutical Ingredient (API) - Hydrochlorothiazide. In future, the Company will manufacture this formulation utilizing its facilities in India. The Company is setting up a new formulations manufacturing facility meeting U.S. regulatory requirements at SEZ Indore. The Company is already holding DMFs of Hydrochlorothiazide in various countries.

Ranbaxy will commercialise this product in the U.S. market utilizing its established marketing expertise and distribution network.

Source : Equity Bulls

Keywords