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Aseptic Manufacturing Operation: Chinese Company Zhuhai United Laboratories does not comply with EU GMP

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Originally posted on DRUG REGULATORY AFFAIRS INTERNATIONAL:

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see   http://www.gmp-compliance.org/enews_04887_Aseptic-Manufacturing-Operation-Chinese-Company-Zhuhai-United-Laboratories-does-not-comply-with-EU-GMP_9345,S-WKS_n.html

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While the focus of attention has been on Indian manufacturers during the last 2 years now also Chinese manufacturers are in the spot light. On 15 June 2015 the National Agency for Medicines and Medical Devices of Romania entered a GMP Non-Compliance Report for Zhuhai United Laboratories into EudraGMDP. Read more about the GMP deviations observed at Zhuhai United.

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While the focus of attention has been on Indian manufacturers during the last 2 years now also Chinese manufacturers are again in the spot light. Just recently the EU found serious GMP deviations at an API manufacturer (Huzhou Sunflower Pharmaceuticals) and on 15 June 2015 the National Agency for Medicines and Medical Devices of Romania entered a GMP Non-Compliance Report for Zhuhai United Laboratories Co., LTD located at Sanzao Science &Technology Park, National Hi-Tech Zone, Zhuhai, Guangdong, 519040, China into EudraGMDP.

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According to the report issued by the…

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