Health Canada, which has been accused of not providing the public with enough info about quality concerns over the drugs sold there, says it will increase the number of plant inspections it will do and put more information online.
The FDA accepted Apotex's application to copy an Amgen blockbuster, giving the Canadian drugmaker a chance to cash in on the coming biosimilar boom in the U.S.
An Apotex plant in Brantford, Ontario, was cited in a November inspection for equipment that was not properly cleaned and was found to be contaminated, according to a report in The Star. The plant was also cited for not having password-protected computers that could prevent employees from altering or deleting testing data.
Canadian generics maker Apotex is recalling tens of thousands of bottles of a blood pressure medication manufactured at a plant in India which the FDA banned after discovering it had been faking test data for years.
More than three dozen drugs and APIs that were originally banned by health regulators in Canada will be allowed into the country because they are medically necessary.
Days after Health Canada said it would talk to the FDA about Apotex, the regulator has banned the import of finished dosage forms and APIs from two of the drugmaker's plants in India.
The three-way spat between Health Canada, local media and Apotex is rumbling on. Late last week Health Canada won an equivocal thumbs-up from the media for its move to quarantine products from one of Apotex's Indian plants, only for the generic drugmaker to hit back with a press release to "set the record straight."
Apotex, the Canadian generics maker that has had years of regulatory run-ins with the FDA, is recalling thousands of bottles of generic Paxil. This time regulators can't point fingers at Apotex. The drugs were manufactured by GlaxoSmithKline and are part of a larger recall for which the FDA spanked GSK.
It's tough luck for Canada's Apotex in its international slug fest with the FDA. An arbitration panel has tossed its claim that the FDA violated the North American Free Trade Act when it banned products from its plants in Toronto and Quebec from 2009 to 2011.
In April, the FDA banned a plant in Bangalore, India, owned by Canadian generics maker Apotex. An FDA warning letter posted today explains why.