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Amhwa Biology export qualification of EU API approved


Recently, after the review of the Shandong Provincial Drug Administration, Amhwa Biology officially approved the qualification of the Export of raw material drugs to the EU. As the second API supplier in China to master the extraction of sodium hyaluronate by biological fermentation, this approval marks the official entry of Amhwa Biology ProHA ® sodium hyaluronate API into the EU market.

In 2011, the European Union issued a new directive 2011/62/EU for API, requiring the import of API into EU member states. The manufacturer must obtain a certificate issued by the drug regulatory authority of the exporting country.

Amhwa Biology strictly follows the requirements of Chinese pharmaceutical GMP, GMP of EU, WHO, and ICH Q7 pharmaceutical GMP requirements, and regularly, strictly, and transparently accepts the supervision of the Drug Administration to ensure that ProHA® sodium hyaluronate API meet international quality.

The Shandong Provincial Drug Administration appointed an expert group to conduct a comprehensive and detailed review of the implementation of the new version of GMP in our company. After the preliminary review, on-site inspection, and comprehensive assessment of the expert group, it was confirmed that our company met the GMP requirements of the "Good Practice for Drug Production Quality Management (Revised in 2010)".

The approval of the "Export of EU API Certification Document" will strongly promote Amhwa Biology to further explore the EU and other countries' API market in the future, and Amhwa Biology will continue to provide high-quality products and services for domestic and foreign customers.

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