Hubei Biocause Phamaceutical Co., Ltd.
#122Yangwan Road,Jingmen, Hubei, China
Tel.:++86 (0)27 65651730 / 85628285
Fax.:++86 (0)27 65652329
Email:export@biocause.com,export@biocause.net
Quality Assurance & Regulatory Affairs
With well established quality assurance system & regulatory team, we have passed US FDA inspections, EU GMP inspection all on first attempts, covering 3 API facilities and multi-APIs for our kilo production site as well as hundreds tons commercial site.
- 2014 FDA inspection approval Covering 7 APIs (Wuhan Biocause Development)
- 2013 FDA re-inspection, no 483 (Hubei Granules-Biocause)
- 2011 EU GMP inspection approval covering 2 APIs, two facilities (Hubei Granules-Biocause & Hubei Biocause Heilen )
- 2010 FDA inspection approval covering 4 APIs (Wuhan Biocause Development)
- 2009 FDA inspection approval, no 483 (Hubei Granules-Biocause)
- 2004 FDA inspection approval covering 2 APIs, no 483 (Wuhan Biocause Development)
- Awarded as “the Best Supplier in Pacific Region” by GSK Tianjin 4 times in2002, 2005, 2011 &2012
- Promptly preparing DMFs and registering worldwide
- Process Validation
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Analytical Method Validation for impurity profile, assay, and residual solvents
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