cGMPs

FDA Bans Imports from India's Emcure

Source: Economic Times of India

Jul 15, 2015

The U.S. FDA has banned imports from Emcure's Hinjewadi manufacturing plant in the western India after an inspection revealed the drugmaker was not meeting manufacturing quality standards.

Emcure, one of India's top 20 drug makers, manufactures antibiotics as well as drugs used in cardiology and gynecology. Emcure has partnered with global drugmakers such Pfizer, Roche, Novartis and Sanofi.

The FDA recall alert noted GMP violations in the manufacture of all but 9 drugs, which were excluded from the "detention without physical examination" mandate.

Read the FDA import alert

Read the ET release