Quality Assurance

Our FDA inspected and approved third party laboratories safe guard our production to meet the world’s highest standards for quality control.

 

Regulatory Support

To achieve FDA/COS approval seems a complicated and difficult mission. We offer a QA and regulatory package including DMF/VMF/EDMF filing, source qualification, cGMP auditing, CAPA, and quality engineering management. We are proud to have obtained a number of successful FDA approvals of our contract API manufacturers since 2005.

In Sep. 2009, we helped through our contract manufacturer of Lincomycin HCl, NCPC Huanluan, in successfully passing the FDA re-audit with Zero 483.

In Oct. 2012, our on-site QA and regulatory support had helped CSPC Zhongrun to successfully pass the U.S. FDA inspection for Penicillin G Potassium.

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In Nov. 2013, Hebei Jianmin Starch Glucose co., ltd, the biggest producer of OTC serial products in the world, successfully passed U.S. FDA inspection with our strong support and guidance.

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In Aug. 2014, our contract manufacturer Ningxia Tairui successfully passed U.S. FDA inspection for Tylosin Tartrate with our strong support and guidance.

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In Jun. 2015,  Inner Mongolia Changsheng Pharmaceutical Co., Ltd successfully passed U.S. FDA inspection for Penicillin with our strong support and guidance.

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In Nov. 2-6, 2015, our contract manufacturer Livzon New North River Pharmaceutical Co.,Ltd (LIVZON NNR) successfully passed U.S. FDA inspection with 0483 for Mexidectin with our strong support and guidance.

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In Dec. 14-18, 2015, we helped through our contract manufacturer of Lincomycin HCl, NCPC Huanluan, in successfully passing the FDA re-audit with Zero 483.

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Logistic Service

Our logistics department manage shipments to more than 30 world-wide destinations weekly. Our conveniently located warehouse in the US assures timely delivery to your facility.

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