ChemWerth-Represented Manufacturers'
FDA Inspections & Approvals 2005-2010

Congratulations to All!

During September 8 to 26, ChemWerth, Inc. successfully represented five factories in eight different FDA site inspections. “The most difficult part, other than the inspections, was the coordination of the FDA’s five inspection teams with the associated factory sites’ regulatory teams. This could have been a logistical nightmare. Thankfully, ChemWerth’s Shanghai factory inspection teams, along with the help from our US regulatory staff, is well trained and prepared to handle multiple FDA inspections in such high pressure situations.” Commented Song Lin, Executive VP of ChemWerth. 
           
The FDA inspections covered the following APIs: Granisetron Hydrochloride, Clindamycin Hydrochloride and Clindamycin Phosphate (Chongqing Carelife Pharmaceuticals), Gemcitabine Hydrochloride (Jiangsu Hansen Pharmaceuticals), Ifosfamide and Etoposide (Jiangsu HengRui Pharmaceuticals), Fosphenytoin Sodium (Shanghai Ziyuan Pharmaceuticals) and Vecuronium Bromide (Zhejiang XianJu Pharmaceuticals).
           
There were a few minor 483s issued that ChemWerth responded to 30 days after each inspection. “The API factories represented by ChemWerth have been going through the very lengthy and extremely strict regulatory inspection process to maintain the highest possible FDA quality standards at all times. These are some of the benefits of working with ChemWerth.” Stated Song Lin.

  • Yichang Sanxia Pharmaceutical Co. – July 2009 (pending EIR)
  • Wuhan Grand Pharmaceutical Co. – May 2009
  • Fujian Kerui Pharmaceutical Co. – February 2009 (pending EIR)
  • AmbioPharm, Inc. – November 2008 (No 483 issued)
  • Jiangsu Hengrui Medicine Co. - September, 2008
  • Jiangsu Hansen Pharmaceutical Co. - September, 2008
  • Shanghai Ziyuan Pharmaceutical Co. - September, 2008 (No 483 issued)
  • 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 (No 483 issued)
  • Strem Chemical  Co. USA — October 2007 (No 483 issued)
  • Strem Chemical  Co. USA — July 2007
  • Chongqing Carelife Pharmaceutical Co. Ltd — April 2007
  • North China Pharmaceutical Co. Ltd — March, 2006
  • Qilu Pharmaceutical Co. Ltd (No 483 issued) — November, 2005
  • Huzhou Zhanwang Pharmaceutical Co. Ltd — November, 2005
  • Shanghai Ziyuan Pharmaceutical Co. Ltd (No 483 issues) — October, 2005
  • Strem Chemical Co. USA (No 483 issued) — August, 2005
  • Chongqing Carelife Pharmaceutical Co. Ltd (No 483 issued) — July, 2005
  • Chongqing Daxin Pharmaceutical Co. Ltd (no 483 issued) — July, 2005
  • ChemWerth Shanghai Laboratory (No 483 issued) — July, 2005
  • Yichang Sanxia Pharmaceutical Company Factory — March, 2005
  • Sanmar Speciality Chemicals Ltd Pharmaceuticals (India) (No 483 issued) — 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. 

 

<< Return to ChemWerth News