9/11/2012 7:49:44 AM
Late last month, Sun Pharma happily declared that its Caraco unit was finally in compliance with good manufacturing practices after receiving notice from the FDA. This meant that two manufacturing and packaging facilities in Michigan were able to resume limited operations after various inspections and so-called 483 reports had been issued by the agency. Specifically, Caraco can now resume production of just two products – 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 Indian drugmaker, whose unit had been operating under a 2009 consent decree, said in a statement. Regular inspections will, otherwise, continue for an extended period.
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