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."
Health Canada began the chain of events by asking Apotex to quarantine products manufactured at its finished dosage form plant in Bangalore, India, which was placed on FDA import alert on Sept. 22. The Canadian regulator said Apotex "will stop distribution of products in its possession" while the quarantine is in force, giving authorities time to talk to the FDA about why it imposed the import alert and decide what actions to take.
Within two days of the Health Canada statement, Apotex had published its own release titled "Setting the Record Straight: Products are Safe and Effective." In the release, Apotex said it tests every lot of finished products it ships to Canada and as such is confident its drugs are safe and effective. The generic manufacturer also pointed to the compliant rating Health Canada awarded the plant in February as evidence of the quality of its products.
The plant in question is located next to the Bangalore API facility that received a damning FDA warning letter in June. FDA placed an import alert on the API facility in April and applied the same restriction on the neighboring finished dosage facility last week.