USA – FDA issues import alert on Indian drugmaker

Just a few months after India-based drugmaker Shilpa Medicare found itself in the FDA’s crosshairs, the company now faces a ban on the vast majority of its products in the U.S.

The FDA slapped an import alert on Shilpa Medicare’s formulation plant in Telangana, India, according to a notice posted Thursday. The product ban comes on the heels of an FDA warning letter that cited the Indian drugmaker for multiple manufacturing violations. 

The FDA spared three Shilpa drugs in its alert: injectable azacitidine—used to treat myelodysplastic syndrome—plus cyclophosphamide capsules and erlotinib tablets, all of which are chemotherapies for cancer. Those drugs just so happen to account for the bulk of Shilpa’s sales, too, Express Pharma reports. Meanwhile, injectable azacitidine has also found its way onto the FDA’s drug shortage…