Sun Pharmaceutical's US subsidiary Caraco has been approved to resume manufacturing operations by the US Food and Drug Administration following inspections.
Caraco had previously been warned by the FDA over equality violations at a manufacturing facility and packaging sites in Detroit and Wixom, Michigan, US, culminating in the agency seizing drugs in 2009. Caraco entered into a Consent Decree with the FDA in the aftermath of the seizure, under which the company agreed to take specific actions.
The decree read that Caraco would cease the manufacture of drugs until the company received written notification from independent experts and the US regulatory authorities, deeming the company to be compliant with regulations.
Inspections had taken place earlier this year, with Caraco taking corrective action to resolve the complaints raised. As a result, Caraco has announced that is now in compliance with "relevant paragraphs of the Consent Decree".
In order to ensure that standards remain adequate the company will now work alongside an external auditor, with regular inspections being conducted for an extended period of time.
The FDA has now green-lit the production of cardiovascular drug Carvedilol and antibiotic Paramomycin at the site, with the company confirming that; "Manufacturing of other products from these sites, including those pending approval with the USFDA, will be subject to similar rigorous approval procedure."