FDA Adds Canadian Drugmaker Apotex's India Plant to Ban List

Apr 03, 2014


The U.S. FDA banned imports from Canadian drugmaker Apotex Inc.'s manufacturing plant in Bangalore, India for failing to conform with current good manufacturing practices.

Drugs made at the plant, with the exception of Riluzole, a drug used to treat Lou Gehrig's disease, will be detained without physical examination.

Apotex is the largest producer of generic drugs in Canada. The newly operational manufacturing facility in Bangalore handles wet granulation, dry granulation and direct compression products in addition to the film coating of tablets, according to the Apotex website.

Apotex's Toronto and Quebec plants faced previous U.S. import bans from 2009-2011, after FDA inspections revealed GMP violations.

See the FDA Import Alert

Read the Reuters press release