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MUMBAI, India — The Food and Drug Administration has determined that generic drug maker Caraco is in compliance with relevant paragraphs of the consent decree and may resume operations at its manufacturing facility and packaging sites in Detriot and Wixom, Mich., Caraco's parent company Sun Pharmaceutical Industries said.
During their inspection, the FDA reviewed the certification reports for heart failure treatment Carvedilol USP, as well as antibiotic Paramomycin USP, and determined Caraco may resume production of only these two drugs.
"Manufacturing of other products from these sites, including those pending approval with [the FDA], will be subject to similar rigorous approval procedure," Sun Pharma said. "As a result, the increase in production at these sites and resultant revenue contribution is expected to be gradual."