Detention of Drugs from Sri Krishna Pharma by Health Canada
Health Canada requested the Canadian importers to detain health products which use raw materials from the API manufacturer, Sri Krishna Pharmaceuticals due to quality issues related with the reliability of the laboratory data generated and data integrity issues at its manufacturing unit.
Recently regulatory bodies like USFDA and Italy’s ALFA raised questions regarding the reliability of the laboratory data generated at the manufacturing site of Sri Krishna Pharmaceuticals. Based on this information Health Canada took decision to detain the products as a precautionary measure to reduce the risk.
A senior official at Sri Krishna Pharmaceuticals said that they have already answered the queries raised by the USFDA and Italy’s ALFA on the basis of which Canadian regulators took the action.
The GMP certificate withdrawal has no impact on any of the Sri Krishna’s API manufacturing sites.