This content is current only at the time of printing. This document was printed on 9 December 2019. A current copy is located at https://apvma.gov.au/node/20991
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Issues with actives and products manufactured by Hisun
The APVMA has recently become aware of potential issues relating to the manufacture of actives and products by Zhejiang Hisun Pharmaceutical Co, Ltd, at the following 3 locations:
- 46 Waisha Road, Jiaojiang District, Taizhou City, Zhejiang (Waisha Campus)
- 56 Binhai Road, Jiaojiang District , Taizhou City, Zhejiang (Yantou Campus)
- 1 Haizheng Avenue, Jiaojiang District, Taizhou City, Zhejiang (East Factory Campus).
This follows from investigations by the relevant Spanish Authority and US FDA. See US FDA link at www.fda.gov/iceci/enforcementactions/warningletters/2015/ucm480035.htm
The APVMA is in the process of obtaining further information and working with other authorities, before it can finalise its approach. Pending its final approach, the APVMA will be taking the following action:
- For products, which, based on the APVMA’s current records, contain active constituents sourced from any of the sites identified above, the APVMA will write to relevant product holders informing them of the potential issue and recommending that appropriate testing be undertaken to ensure the quality and safety of products. The APVMA will also suggest that alternative sources be considered.
- For pending applications which identify the sites, the APVMA will be contacting applicants to inform them of the issue and possible options.
- The APVMA will not, pending consideration of all relevant information, be approving any new applications which identify the source of actives or products from any one of the 3 listed above.
If you have sourced or are intending to source active constituents or products from any one of the three sites listed above, please contact your case manager. You may wish to consider sourcing active constituents from an alternative site of manufacture instead. Similarly, you may wish to consider an alternative site of manufacture for products.