Sun Pharmaceuticals' drug manufacturing plant in Gujarat, India, received an import alert from the FDA Dec. 7, which could threaten the drugmakers' ability to ship drugs to the U.S.
The regulatory move comes after inspectors detected issues at the plant during a site visit between April 26 and May 9. The import alert implies that all future shipments from the facility could be refused entry to the U.S. until the plant becomes compliant with Current Good Manufacturing Practice standards. Due to shortage concerns, the FDA has excluded 14 drugs from this mandate, including the heart failure drug digoxin and the chemotherapy drug doxorubicin.
"The company continues to cooperate with the U.S. FDA and will undertake all necessary steps to resolve these issues and to ensure that the regulator is completely satisfied with the company’s remedial action," Sun Pharma said in a Dec. 8 filing to the National Stock Exchange of India.
It was not immediately clear what remedial action the FDA asked Sun Pharma to take.
The drugs manufactured at the facility and sold to the U.S. accounted for about 3 percent of the drugmaker's consolidated revenues in the year ended March 31. This total includes the 14 drugs excluded from the import alert.