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Xintai Pharmaceutical Entecavir API GMP Certificate

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  • Time of issue:2015-09-30 01:56
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Xintai Pharmaceutical Entecavir API GMP Certificate

(Summary description)Xintai Pharmaceutical's Entecavir API project, a wholly-owned subsidiary of Borui, passed the cFDA on-site inspection in July 2015 and successfully obtained the China Pharmaceutical GMP Certificate on September 28, 2015.

  • Categories:NEW
  • Author:
  • Origin:
  • Time of issue:2015-09-30 01:56
  • Views:0
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Xintai Pharmaceutical's Entecavir API project, a wholly-owned subsidiary of Borui, passed the cFDA on-site inspection in July 2015 and successfully obtained the China Pharmaceutical GMP Certificate on September 28, 2015.
 
This will be Borui Bio starting from zero, going through the entire process of drug development, registration and production in China, from building a factory, building a pharmaceutical production quality management system, applying for a drug production license, applying for a drug approval document number, and applying for drug GMP certification. Drugs that meet all regulations, rules and technical guidelines and have successfully obtained all administrative permits. Entecavir is the first drug that Borui Bio can legally sell in China. It marked that Borui Bio opened a new page on the journey of drug development and industrialization.

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