Health Canada quarantines pharma ingredients from Hyderabad firm

Health Canada quarantines pharma ingredients from Hyderabad firm
Highlights

Canadian importers have agreed to Health Canada\'s request to quarantine health products made with active pharmaceutical ingredients (APIs) from city-based Sri Krishna Pharmaceuticals Ltd., due to data integrity concerns. Health Canada had asked the firms to voluntarily stop shipment of products to Canada,

Reason cited for quarantining active pharmaceutical ingredients (APIs) from the city-based Sri Krishna Pharmaceuticals Ltd from has been data integrity concerns

Canadian importers have agreed to Health Canada's request to quarantine health products made with active pharmaceutical ingredients (APIs) from city-based Sri Krishna Pharmaceuticals Ltd., due to data integrity concerns. Health Canada had asked the firms to voluntarily stop shipment of products to Canada, based on a review of recent manufacturing practices by the US Food and Drug Administration (FDA), which had found falsification and manipulation of data issues at pharmaceutical company IPCA Laboratories, which manufactures more than 350 drug formulations.

The agency is apparently taking this action as an interim precautionary measure to help mitigate any potential risk. The quarantine means that the Canadian importers and distributors have agreed to stop distributing APIs or finished dosage form products containing active ingredients from the city firm. At this time there is no identified risk to health, and Health Canada has not requesting a recall of any of the products, either.

The agency has also compiled an initial list of products affected by the quarantine. The list will be updated as new information becomes available. Any medically necessary products would undergo appropriate testing to address any potential safety concerns.

“Health Canada will also continue to work with international partners and Canadian importers to gather and assess information regarding the situation and take action as necessary to help protect its native citizens,” reports Pharmabiz. It requested Canadians to refrain from making any changes to their medication without consulting with a healthcare professional.

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