Quality Profile

Xinhua has proudly maintained an impeccable record of producing superior quality products during our more than 60 years existence. Listed below are examples of our many accomplishments.
ISO 9001 certified
Conduct regular audits for continuously monitoring and updating the quality management systems
ISO 10012 certified
6 APIs have been granted acceptance by US FDA as of Dec.31, 2009..
All related cGMP requirements are integrated into the ISO 9001 system for the production of all pharmaceutical products.
The company has an unblemished record of quality production. Since the implementation of the medicine market sampling regulation in 1985 by the Chinese government, samples have been taken from 2787 production lots representative of 604 different products have received 100% approval.
The quality of all products manufactured use the latest international pharmacopeias as the baseline for acceptance and also confirm to the standard/ special requirements of our clients.
9 API have been granted the Certificate of Suitability (COS) by the European Department for the Quality of Medicine as of Dec.31, 2009.
All the finished dosage products have been SFDA GMP certified.

All the API Products have been SFDA GMP certified