The import alert says that drugs manufactured at the facility operated by the company's Indian subsidiary Apotex Pharmachem India Pvt Ltd (APIPL), will be detained without physical examination as the drugs do not conform to good manufacturing practice standards. The alert excludes Riluzole, a drug used to treat a type of neuromuscular degenerative disorder.
APIPL's plant in Bangalore manufactures active pharmaceutical ingredients (APIs) has a total installed capacity of 31,000 litres, according to the website. The facility has two production blocks.
The facility had received two Form 483s in 2013 after USFDA inspections concluded on June 22 and July 12, 2013, according to data from the regulator. A R&D facility located in the same complex, was also inspected in November 2012, however it did not raise any red flags.