ChemWerth-Represented Manufacturers'
FDA Inspections & Approvals 2005-2011

CW regulatory works with Chinese factories to secure five new FDA approvals
the second half of 2010.

The FDA has been raising the bar in China when it comes to FDA approval. Gone are the days of zero point 483s. The FDA is building up its forces in China in order to raise the standards of all drug products coming into the US. ChemWerth applauds this effort and is looking forward to increased diligence by the FDA.

ChemWerth has invested millions of dollars and thousands of man hours into their partner factories in order to assure CW’s partner factories are at the highest level of compliance 24 hours a day. ChemWerth’s goal is to continue to be the industry leader in China for quality material and regulatory compliance for the regulated markets.

In a time where many companies focus on the cost rather than the quality of supply out of China, isn’t it reassuring that there is still a company where quality is still and will always be the most important factor?

 

ChemWerth: FIRST TO QUALITY. FAST TO  MARKET.

New FDA Inspections:

  • Jiangsu Hansoh Pharmaceutical Co. – October 2010
  • Huzhou Zhanwang Pharmaceutical Co. – September 2010
  • Sichuan Credit ChemWerth Pharmaceutical Co. – August 2010
  • Chongqing Pharmaceutical Research Institute Co. – August 2010
  • Jinan Jinda Pharmaceutical & Chemical Co. – July 2010
  • Jiangxi Guoyao Pharmaceutical Co. – September 2009
  • Yichang Sanxia Pharmaceutical Co. – July 2009
  • Wuhan Grand Pharmaceutical Co. – May 2009
  • Fujian Kerui Pharmaceutical Co. – February 2009
  • AmbioPharm, Inc. – November 2008
  • Jiangsu Hengrui Medicine Co. - September, 2008
  • Jiangsu Hansen Pharmaceutical Co. - September, 2008
  • Shanghai Ziyuan Pharmaceutical Co. - September, 2008
  • Zhejiang Xianju Pharmaceutical Co. - September, 2008
  • Chongqing Carelife Pharmaceutical Co. Ltd (New Facility) — September, 2008
  • SAI Adventium Pharma, Ltd. – March 2008
  • ChemCon GmbH (Germany) — December 2007
  • Shandong Qilu Pharmaceutical Co. Ltd — October 2007
  • Strem Chemical Co. USA — October 2007
  • Strem Chemical Co. USA — July 2007
  • Chongqing Carelife Pharmaceutical Co. Ltd — April 2007
  • North China Pharmaceutical Co. Ltd — March, 2006
  • Qilu Pharmaceutical Co. Ltd — November, 2005
  • Huzhou Zhanwang Pharmaceutical Co. Ltd — November, 2005
  • Shanghai Ziyuan Pharmaceutical Co. Ltd— October, 2005
  • Strem Chemical Co. USA— August, 2005
  • Chongqing Carelife Pharmaceutical Co. Ltd— July, 2005
  • Chongqing Daxin Pharmaceutical Co. Ltd— July, 2005
  • ChemWerth Shanghai Laboratory— July, 2005
  • Yichang Sanxia Pharmaceutical Company Factory — March, 2005
  • Sanmar Speciality Chemicals Ltd Pharmaceuticals (India)— January 2005

ChemWerth is a full service product development company that can get you difficult to find APIs. ChemWerth is responsible for the development of the product, certifying that no process patents are violated, providing APIs that meet the ICH guidelines and FDA guidelines for purity and impurities. ChemWerth has a regulatory history of getting our products FDA approved 7-12 months earlier than our competition.

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