The US Food and Drug Administration (USFDA) on 2 April 2014 banned imports from Apotex Inc’s manufacturing plant in India because of not meeting the quality standards.
The FDA banned the imports from the plant situated in Bangalore without physical examination because the plant did not meet the FDA’ manufacturing practices. However, FDA allowed the imports of Riluzole, drug which is used to treat amyotrophic lateral sclerosis commonly called Lou Gehrig’s disease.
Recently, FDA sanctioned a series of ban on top Indian drug makers such as Ranbaxy Laboratories Ltd Wockhardt Ltd and Sun Pharmaceutical Industries Ltd to export to the United States on quality concerns.
About Apotex Inc
Apotex Inc. is the largest Canadian owned pharmaceutical company. It was founded in 1974. Apotex Research Private Limited (ARPL), the Indian Research & Development wing of Apotex Inc. was established in the year 2004 in Bangalore.
At present Apotex manufactures about 260 generic drugs and copies the name-brand pharmaceutical products which are sold in Canada and exported to more than 115 countries.
When: 2 April 2014