FDA Adds Apotex to India-Based Import Ban List

The FDA has banned Canadian generics maker Apotex from importing drugs to the U.S. made at its Bangalore, India, site, pending quality upgrades.

Drugs manufactured at the Apotex Pharmachem India plant will be detained without physical examination, the Apr. 1 import alert says. It excludes the API riluzole, an ingredient used in drugs to treat Lou Gehrig’s disease.

Apotex produces more than 70 approved APIs and has others in varying development stages.
Elie Betito, director of government affairs, said that the company is treating the import ban with “utmost importance” and actively working to resolve the FDA’s concerns.

Apotex sued the FDA in 2012 for a similar ban on products manufactured at two Ontario sites, saying the action had “decimated” its U.S. business. The company accused the agency of treating U.S. drugmakers in similar circumstances more favorably.

Apotex is the latest drugmaker to have its India plants barred from importing drugs to the U.S. due to poor GMP inspections Last month, the FDA issued import alerts on Sun Pharmaceuticals and Marck Biosciences.

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