Health Canada requests quarantine of drugs linked to Polydrug Labs

25 June 2015

Medicines regulator Health Canada has requested that Canadian importers voluntarily quarantine drug products with active pharmaceutical ingredients (APIs) manufactured or tested by Polydrug Laboratories, in Ambarnath, Maharashtra, India, due to data integrity concerns.

Health Canada is taking this interim precautionary measure to help mitigate any potential risk in light of recent findings from trusted regulatory partners that raised concerns about the reliability of data generated at this site. At this time there is no identified risk to health, and Health Canada is not requesting a recall of any products with API from Polydrug Laboratories currently on the Canadian market.

APIs are used to make finished drug products that are sold to consumers. A quarantine will mean that Canadian importers and distributors will stop distributing products in Canada with APIs linked to this site.

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