FDA Puts One More Indian Drugmaker on Import Ban List

The FDA has banned all imports from Emcure Pharmaceuticals’ Hinjewadi, Maharashtra, India, facility due to current good manufacturing practice violations, making it the latest in a growing list of Indian firms facing agency action.

Emcure is the 26th Indian drugmaker — and its Hinjewadi facility is the 42nd facility — to be put on import alert since September 2009, creating a major black eye for India’s pharma industry and its reputation as a global supplier of generic drugs.

The alert, announced last week, affects nine drugs — oral tablets and injectables — including generic versions of Novartis’ osteoporosis drug Zometa (zoledronic acid), Merck’s HIV drug Sustiva (efavirenz), Arbor Pharmaceuticals’ chemotherapy drug Gliadel (carmustine) and Gilead Science’s Vistide (cidofovir), used to treat eye infections in AIDS patients. Also included are the antipsychotic haloperidol, the antibiotic amikacin and the antinausea and vomiting drugs ondansetron, prochlorperazine and metoclopramide.

Emcure has eight other manufacturing plants in India and one in the U.S. None of those sites are affected by the import alert.

Prior to the import alert on Emcure, the most recent ban involved Ipca’s SEZ Indore, Pithampur, and Piparia, Silvassa, plants in March.

Emcure did not respond to a request for comment by press time. To view the updated list of import alerts, go to www.fdanews.com/07-15-15-ImportAlert.pdf. — Kellen Owings