FDA pre-approval on Bupropion HCl

 

From Feb.1 to 3, 2007, HJV had been audited by the RCI INC of USA on production, QA, QC,equipment, etc. The final meeting shows that the situation mentioned in the DMF is there in the site, and the company can strictly follow the requirements of cGMP on six systems, its production, quality, employee and environment meets the relavant regulations.


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