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Corporate - Regulatory Bodies & Rulings
Zydus Cadila gets USFDA nod

Ahmedabad, Sept. 25

Zydus Cadila has received an approval from the USFDA for hydroxychloroquine sulfate tablets in the strength of 200 mg. The drug falls in the DMARD (Disease Modifying Anti-Rheumatic Drug) segment and is used in the treatment of rheumatoid arthritis. The sales of this drug in the US market in 2006 as per NDC Health were estimated at $30 million, the company said in a release here today. The company will market the drug through its US subsidiary, Zydus Pharmaceuticals (USA) Inc. The group has 27 approvals since the commencement of filing process in fiscal 2003-04. So far, it has filed 65 ANDAs (abbreviated new drug applications) and 55 DMFs (drug master files). —

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