Sun Pharma’s subsidiary resolves USFDA warning letter

19 Sep 2011 Evaluate

Sun Pharmaceutical Industries’ subsidiary - Caraco has received an approval for its manufacturing facility by the U.S Food and Drug Administration (USFDA). The regulator on June 2011 had re-inspected the company’s manufacturing facility located at Cranbury, New Jersey, for which the site has received an acceptable regulatory status. Therefore, the issue noted in the August 25, 2010, warning letter are considered to be resolved. Caraco, wholly owned by Sun Pharma, continues to work with consultants to resolve the issue raised by the USFDA at its Detroit plant.

Recently, the company’s subsidiary had been granted approval from USFDA for its Abbreviated New Drug Application (ANDA) for generic version of Plavix, clopidogrel tablets USP.

Sun Pharmaceutical Industries manufactures and markets a large basket of pharmaceutical formulations as branded generics as well as generics in India, US and several other markets across the world.

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