Tag:

Apotex

Latest Headlines

Latest Headlines

Apotex recalling blood pressure med made at banned plant in India

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.  

Canada cuts Apotex a break on some banned drugs

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.

Health Canada places import ban on Apotex and IPCA Laboratories

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.

Apotex tries to 'set the record straight' after Health Canada quarantine request

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 recalls Paxil tainted at GSK plant

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.

NAFTA says FDA was in its rights to ban Apotex plants

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.

FDA's ban on Apotex India plant stems from faked test data

In April, the FDA banned a plant in Bangalore, India, owned by Canadian generics maker Apotex. An FDA warning letter posted today explains why.

FDA says Apotex India plant has faked data for years

In April, the FDA banned a plant in Bangalore, India, owned by Canadian generic drugmaker Apotex. A warning letter sent last week and posted today by the FDA says that among other issues, it found that the company had deleted data of failed test results and then reported that the batches had passed.

Canadian drugmaker's Indian plant joins FDA import ban parade

The FDA has banned a handful of plants from some of India's biggest drugmakers in the last year, actions that have led to grumbling that the regulator is picking on Indian-owned operations. But now a plant in India owned by a Canadian firm has gotten the same treatment, an import alert that blocks products from being shipped to the U.S.

Apotex plant in India tagged with import ban

The FDA has again issued an import alert against a plant owned by Canadian generic drugmaker Apotex, this one in India. The last time the agency took that kind of action, Apotex took the matter to international authorities in a North American Free Trade Agreement complaint.