- Apotex Pharmachem India Pvt Ltd (APIPL)
- Apotex Research Private Limited (ARPL)
- IPCA Laboratories
Health Canada has compiled an initial list of products affected by the Import ban.
CLICK HERE TO VIEW COMPLETE LIST OF PRODUCTS AFFECTED BY IMPORT BAN
The list will be updated periodically.
Certain medically necessary products may be excluded from the action on the condition they are tested by an independent third party before being released for use or sale. Independent testing against specifications will provide confidence that these products meet Canadian quality standards, and will allow consumers to have continued access to medically necessary and safe products.
When data integrity issues were first identified at each of these sites by the U.S. Food and Drug Administration (FDA), Health Canada took action to protect the health and safety of Canadians. There is currently a voluntary quarantine on products from ARPL and IPCA. Products from APIPL have been undergoing additional testing, as required by Health Canada before being allowed on the Canadian market.
Health Canada continues to gather information about the situation at these three sites from trusted regulatory partners, including the FDA. Based on recent information, the Department has significant concerns with the manner in which data are collected and reported, raising serious doubts about the quality and safety of finished products and APIs produced at these sites. Until Health Canada can be satisfied that the production processes used at these three sites meet internationally recognized good manufacturing practices (GMP), it is taking this additional precautionary step to keep these products off the Canadian market.
For more details CLICK HERE
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