Health Canada's announcement about Zhejiang Huahai Pharmaceuticals
Details on non-compliance notice for active pharmaceutical ingredients (APIs) manufacturer Zhejiang Huahai Pharmaceuticals.
Oct 03, 2018
Following Health Canada's notice suspending imports of drugs containing active pharmaceutical ingredients (APIs) from manufacturer Zhejiang Huahai Pharmaceuticals, Sandoz Canada wishes to inform that safety tests conducted to date on this supplier's APIs have not revealed any issues related to our products.
As specified by Health Canada, the non-compliant rating awarded to Huahai relates to requirements for Good Manufacturing Practices (GMPs) and does not necessarily indicate a safety concern for the APIs produced at the targeted manufacturing site and the products containing them.
Sandoz Canada is actively working to assess the stock availability for products containing APIs from Huahai with a top priority of facilitating continuous supply of its products. It is important to note that according to Health Canada, no products containing APIs from the concerned Huahai site have been identified as medically necessary.
Sandoz Canada is committed to ensuring that its marketed products meet the highest standards of quality and that access to its medicines for patients is maintained. Sandoz is closely working with Health Canada on this issue and will update this page with any new information available.