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Sun Pharma In The News

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Sun Pharma's Caraco gets FDA nod to resume drug production

 

MUMBAI headquartered Sun Pharmaceuticals' subsidiary company Caraco Pharmaceuticals has got partial clearance from US food and drugs administration (FDA) to re­sume operations at its manufacturing facility and packaging sites at Detroit and Wixom, in Michigan, US and produce the two drugs. Manufacturing was stopped at the facility due to quality concerns.
 
Accordingly, Caraco can immediately resume production of only Carvedilol USP and Paramomycin USP.
 
"Manufacturing of other products from these sites, including those pending approval with the USFDA, will be subject to similar rigorous approval procedure. As a result, the increase in production at these sites and resultant revenue contribution is expected to be gradual", the company said in a statement. During its inspection, USFDA reviewed certification reports for production of Carvedilol USP as well as Paramomycin USP and subsequently reviewed corrective actions. USFDA has determined Caraco to be in compliance with relevant paragraphs of the Consent Decree.
 
In 2009, USFDA had banned Caraco's manufacturing operations at its Detroit plant for alleged violation of good manufacturing practice (GMP) norms.