First Chinese company receives EXCiPACT certification

Boai NKY Pharmaceuticals is recognised as manufacturing pharmaceutical excipients according to the EXCiPACT GMP standard

The first EXCiPACT Certificate in China has been awarded to Boai NKY Pharmaceuticals by Bureau Veritas Hong Kong, the latest addition to the EXCiPACT's internationally recognised certification bodies.

The certificate demonstrates that the Chinese company's site in Jiaozuo, Henan Province, China manufactures pharmaceutical excipients according to the EXCiPACT Good Manufacturing Practice (GMP) Certification Standard.

This is the 23rd site to be certified globally to date. The others are in Canada, Belgium, Germany, France, India, The Netherlands, Saudi Arabia, Spain and the UK.

EU and US pharmaceutical regulations now require drug manufacturers to conduct either their own or commission third party physical audits of all their starting material suppliers to demonstrate GMP and/or GDP compliance thus increasing the audit burden.

Using GMP and GDP standards designed for excipients, the EXCiPACT Certification Scheme is already helping excipient users and suppliers to reduce their audit burden, save costs and assure quality.

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