FDA Approvals

Inspections PassedChemWerth-Represented Manufacturers’
FDA Inspections & Approvals

With more than 90 successful inspections over the past 10 years and a 30+ year relationship with the FDA, ChemWerth’s track record of regulatory and compliance excellence is unmatched.

Starting with careful factory selection, we develop a hands-on approach with our partner manufacturers; performing routine audits, quality checks, compliance reviews and feedback that ensures high quality pharmaceutical grade API is consistently manufactured.

Our factories meet ICH Guidelines, are WHO compliant, cGMP qualified and USFDA approved making sure your Finished Dosage is compliant, effective and meets regulatory criteria in markets worldwide.


Our History of Compliance

2015

  • Enaltec Labs – November
  • SAI site I – November (Zero 483s)
  • North China Pharmaceutical Huasheng – September
  • Sichuan Credit-ChemWerth Pharmaceutical Co. – July (Zero 483s)
  • Jiangxi Guoyao Pharmaceutical – May
  • Fujian Kerui Pharmaceutical Company – May
  • Shandong Qilu King-Phar Pharmaceutical – April (Zero 483s)
  • Chengdu Shengnuo BioPharm Co. – April (Zero 483s)
  • Tianjin Pacific Pharmaceutical Co. – April (Zero 483s)
  • Chongqing Daxin Pharmaceutical Co. – January
  • Enoray – January

2014

  • Tianjin Weijie Pharmaceutical Co. – September
  • Zhejiang Ruibang Laboratories – June
  • Xian Libang Pharmaceutical Co. – May
  • Lianyungang Runzhong Pharmaceutical Co. – March (Zero 483s)

2013

  • NCPC – November
  • CPRI – October
  • Qilu General – September (Zero 483s)
  • Huzhou Zhanwang Pharmaceutical Co. – September
  • Enaltec Labs – August (Zero 483s)
  • Chongqing Daxin Pharmaceutical Co. – April (Zero 483s)
  • Jinan Jinda Pharmaceutical Chemistry Co. – March
2012

  • Jiangsu Hengrui Medicine Co. – August (Zero 483s)
  • Sichuan Credit-ChemWerth Pharmaceutical Co. – June (Zero 483s)
  • Chongqing Shenghuaxi Pharmaceutical Co. – June (Zero 483s)
  • Chengdu Shengnuo BioPharm Co. – May (Zero 483s)
  • Jiangsu Hansoh Pharmaceutical Co. – March

2011

  • Jiangxi Guoyao Pharmaceutical Co. – December (Zero 483s)
  • Strem Chemical Co. USA — December
  • Tianjin Pacific Pharmaceutical Co. – September (Zero 483s)
  • Shandong Qilu King-Phar Pharmaceutical Co. – August
  • ChemCon GmbH — July (Zero 483s)
  • Yichang Sanxia Pharmaceutical Co. – June (Zero 483s)
  • ChemWerth Pharmaceutical Technology Co. – June (Zero 483s)
  • Tianjin Weijie Pharmaceutical Co. – April (Zero 483s)
  • Fujian Kerui Pharmaceutical Co. – April
  • Xian Libang Pharmaceutical Co. – January