Regulatory Services

FDA/EU-GMP inspection in China

Successful Cases

  • Zhejiang Second Pharmaceutical Co., Ltd. adopted the cGMP (on-site inspection) on sulfamethazine without recorded deficiency on Form 483 by FDA on Nov., 2004.
  • Fujian Fukang Pharmaceutical Co., Ltd. was approved by German authority for EU-GMP compliance in 2004 for Gentamycin sulfate and Chlortetracycline hydrochloride.
  • Zhejiang Apeloa Kangyu Pharmaceutical was approved by German authority for EU-GMP compliance in 2004 for Colistin Sulfate.
  • Changzhou Qianhong Biopharma Co., Ltd. was approved by German authority for EU-GMP compliance in 2003 and 2006 for Heparin Sodium.
  • Wuxi Fortune Pharmaceutical Co., Ltd. was approved by German authority for EU-GMP compliance in 2005 for Spiramycin base.
  • Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. was approved by German authority for EU-GMP compliance in 2006 for Acarbose.
  • Zhejiang Lianhe Chemical Technology Co., Ltd. was approved by German authority for EU-GMP compliance in 2007 for Quetiapine Fumarate.
  • Suzhou No.4 Pharmaceutical Factory was approved by German authority for EU-GMP compliance in 2007 for Lincomycin hydrochloride.
  • Sunshine Lake Pharma Co., received EU-GMP certificate issued by German authority for finished solid dosage forms in Sept. 2007.

Our experts have more than 10 years experience of regulatory consulting services in a famous foreign company and have helped Chinese API and dosage form producers successfully pass more than 20 GMP inspections by EDQM, German authorities and US FDA in the past 6 years.

Now the Chinese GMP regulations, which are being updated by SFDA, are almost same as those from European authority. We would like to contribute our efforts to help more producers complying with the more and more strict regulatory requirements.