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Sun Pharma arm Caraco gets US FDA nod to resume operations

Sun Pharmaceutical Industries on Tuesday said its subsidiary Caraco has received clearance from US Food and Drugs Administration to resume operations at its manufacturing facility and packaging sites at Detroit and Wixom, in Michigan, United States and start production of two drugs.

August 28, 2012 / 07:24 PM IST
 
 
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Sun Pharmaceutical Industries on Tuesday said its subsidiary Caraco has received clearance from US Food and Drugs Administration to resume operations at its manufacturing facility and packaging sites at Detroit and Wixom, in Michigan, United States and start production of two drugs.


Caraco Pharma had been rapped earlier over quality violations. The FDA had issued a warning letter in 2008 and seized drugs manufactured at the Detroit facility in 2009.


"Subsequent to inspections earlier this year and corrective action on 483's, US FDA has determined Caraco to be in compliance with relevant paragraphs of Consent Decree," Sun Pharma said.


Form 483 is used by the FDA to document issues discovered during plant inspections.


However, Caraco can currently resume production of only Carvedilol USP and Paramomycin USP. During the inspection, US FDA reviewed the certification reports for production of the two drugs and subsequently reviewed corrective actions on 483's, it said.


Manufacturing of other products from these sites will be subject to similar rigorous approval procedure, and so increase in production and resultant revenue contribution will be gradual, Sun Pharma said.


Caraco is also required to work with an external auditor conducting regular inspections over an extended period, with reference to other requirements of the consent decree, it added.


Sun Pharma shares were up 1.7% at Rs 681.40 on NSE in late trading on Tuesday.

Also Read: With investor rejecting deal, Sun Taro battle may drag on

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