Concerns over manufacturing processes at Emcure facility prompts Food and Drug Administration to block drug shipments
The US Food and Drug Administration (FDA) has prohibited India’s Emcure Pharmaceuticals from importing drugs manufactured at its Maharashtra-based facility into the US owing to concerns over its manufacturing practices. The FDA import ban applies to human and animal drugs and antibiotics, and only a few of Emcure’s medicines are exempt. Heritage Pharmaceuticals, the US commercial arm of Emcure, refused comment.
The FDA said that Emcure won’t be able to resume shipping its products to the US until it has addressed the issues of concern, and demonstrated a return to compliance with the agency’s good manufacturing practices. Emcure operates nine manufacturing plants, including eight in India and one in the US, five of which are approved by the FDA, according to the company.
Emcure has had other run-ins with the FDA. Previously, FDA inspectors observed problems with Emcure’s practices at one of its sites in India that could have potentially impacted product sterility. Emcure’s site in Pune was also involved in a recall initiated by Israeli drug-maker Teva Pharmaceuticals last year involving methyldopa pills. Other Indian pharma firms have had run-ins with the FDA too, and last year Ranbaxy was banned from importing drugs into the US from a number of its plants.