Latest Headlines

Latest Headlines

Apotex recalls cevimeline hydrochloride drugs made in India as FDA notes stability issues

Within weeks of getting a conditional nod to resume shipments from two of the company's manufacturing units in India, Canada's largest generics maker has recalled 117,644 bottles of cevimeline hydrochloride capsules in the U.S. that were made by the company's Indian arm, Apotex Research, the Business Standard newspaper reports.

Canada allows Apotex Indian plants to regain access to its markets

After the FDA banned a couple of Apotex's plants in India last year, Canadian Health Minister Rona Ambrose had Canadian regulators follow suit. Health Canada has now decided enough improvements have been made by Apotex to let the facilities off the hook, with provisos. The FDA's sanctions, however, remain solidly in place.

Apotex sees Health Canada lift ban on two India plants

Canadian generics maker Apotex has seen Health Canada conditionally lift a ban against two of the company's manufacturing units in India after noting corrective work in progress has passed a threshold, the Toronto Star reports.

Apotex recalling generic Zyprexa because the antipsychotic may be too weak

Canadian generics maker Apotex is recalling more than 35,000 bottles of generic Zyprexa, an antipsychotic, that were manufactured at a plant in Toronto that was recently nicked by the FDA for a number of issues.

Health Canada pledges more plant inspections and more transparency

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.

Apotex targets Amgen's blockbuster with latest biosimilar app

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.

FDA raises issues with another Apotex plant

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.

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.