Resolution of issues with actives and products manufactured by Hisun at some sites

3 October 2017

The APVMA has reviewed its position on the manufacture of actives and products by Zhejiang Hisun Pharmaceutical Co, Ltd, at the following 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).

The APVMA is contacting product holders and affected applicants to advise that we are proceeding to assess applications which nominate these sites. Holders should continue to ensure the quality and safety of their registered products and approved actives in line with normal quality assurance processes.

The APVMA was made aware of potential issues relating to the manufacture or actives and products at these sites in November 2016.This followed from investigations by the relevant Spanish Authority and US FDA.  The APVMA has been working with other authorities and been able to address these concerns. Accordingly, the APVMA is progressing applications involving these sites and working with affected applicants and holders.

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