Indian pharmaceutical company Sun Pharmaceutical’s US-based subsidiary Caraco is set to resume operations at its manufacturing facility and packaging sites in Detriot and Wixom, Michigan after receiving approval from American health regulator.
Subsequent to inspections earlier in 2012 and corrective action, the US Food and Drug Administration (USFDA) has determined Caraco to be in compliance with relevant paragraphs of the consent decree.
During its inspection, the regulator reviewed the certification reports for production of Carvedilol USP as well as Paramomycin USP and stated that Caraco may resume production of only these two products.
According to Sun Pharmaceutical, manufacturing of other products from the sites, including those pending approval with the regulator will be subject to similar approval procedure.
Sun Pharmaceutical manufactures and markets pharmaceutical formulations as branded generics as well as generics in India, US and several other markets across the world.