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Ipca Labs secures FDA nod to market Hydroxychloroquine Sulfate in the US


Published :
Tue, 19 Jun 2007 15:26
By : Agencies
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MUMBAI (Thomson Financial) - Ipca Laboratories Ltd said it has secured US Food and Drug Administration approval to market its disease modifying anti-rheumatic drug, Hydroxychloroquine Sulfate, in the US.

Ipca Labs said it will market tablets of 200 mg strength, which will initially be commercialised by Ranbaxy Laboratories Ltd's unit Ranbaxy Pharmaceuticals Inc.

Ranbaxy will initially manufacture and market the formulation in the US, using Ipca's drug master file approved active pharmaceutical ingredient (API) - Hydroxychloroquine Sulfate, the company said in a release to the Bombay Stock Exchange.

Ipca plans to manufacture this formulation in India, for which it is setting up a new facility that conforms to US regulatory standards in Indore, India.

ami.shah@thomson.com

ami/ssa/jag

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