Our FDA Approvals

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.

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.

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

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

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.

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

In Apr. 2016, we helped our contract manufacturer of Ivermectin, NCPC Aino, successfully pass the FDA audit.

In Jun. 2016, Ningxia Tairui Pharmaceutical Co., Ltd successfully passed U.S. FDA inspection for Tylosin Tartrate with our strong support and guidance.

In Jul. 2016, we helped our contract manufacturer of Oxytetracycline, Hebei Jianmin Starch Glucose Co., Ltd, successfully pass the FDA audit with Zero-483.

In Jul. 2016, our contract manufacturer Chongqing Southwest No.2 Pharmaceutical Factory Co., Ltd, successfully pass the U.S. FDA audit with Zero-483.