Navigation Links
WuXi PharmaTech Receives GLP Certificate from SFDA for Suzhou Toxicology Facility
Date:8/16/2012

SHANGHAI, Aug. 16, 2012 /PRNewswire-Asia/ -- WuXi PharmaTech (NYSE: WX) today announced that its toxicology facility in Suzhou had received a Certificate of Good Laboratory Practice (GLP) from the State Food and Drug Administration (SFDA) of the People's Republic of China after successfully passing two GLP inspections conducted by the SFDA.  Good Laboratory Practice is a quality system concerned with the organizational processes and conditions under which health safety studies are planned, performed, monitored, recorded, archived, and reported.  The receipt of this GLP certificate is an important acknowledgement by the SFDA about the capability of the Suzhou facility to carry out non-clinical laboratory studies with respect to the requirements of the Chinese Food and Drug Act and SFDA GLP Regulations.

Award of the certificate resulted from a four-day inspection conducted by a team of five inspectors from the SFDA in March 2012.  In addition to an extensive facility assessment, the inspection included an audit of 16 studies in areas that included reproductive toxicology (Segment I and II), carcinogenicity, safety pharmacology, dermal irritation, skin phototoxicity, vascular irritation, and immunology.  The facility inspection evaluated key operational sites, including the vivarium rooms, pharmacy, central archive, and laboratories relating to analytical chemistry, bioanalytical services, toxicokinetics, clinical pathology, histopathology, and immunology.  This successful inspection now expands WuXi's capability to conduct all non-clinical laboratory studies regulated by SFDA.  The facility successfully passed an earlier inspection and received a Certificate of Good Laboratory Practice in 2010. 

In May 2012, WuXi announced that it had received a statement of Good Laboratory Practice from Belgium Scientific Institute of Public Health for the Suzhou toxicology facility.

"WuXi's receipt of this certificate is further acknowledgment that we offer our clients non-clinical laboratory studies that meet national and international GLP quality standards," said Edward Hu, Chief Operating Officer and Chief Financial Officer of WuXi PharmaTech.  "This award is additional confirmation of WuXi capability in offering our pharmaceutical and biotech clients a comprehensive, fully integrated platform of pharmaceutical R&D services."

About WuXi PharmaTech

WuXi PharmaTech is a leading pharmaceutical, biotechnology, and medical device R&D outsourcing company, with operations in China and the United States.  As a research-driven and customer-focused company, WuXi PharmaTech provides a broad and integrated portfolio of laboratory and manufacturing services throughout the drug and medical device R&D process.  WuXi PharmaTech's services are designed to assist its global partners in shortening the cycle and lowering the cost of drug and medical device R&D.  WuXi PharmaTech's operating subsidiaries are known as WuXi AppTec.  For more information, please visit http://www.wuxiapptec.com or contact:

Aaron Shi (for the media)
Tel:   +86-21-5046-4362
Email: Aaron_Shi@wuxiapptec.com

Ronald Aldridge (for investors)
Tel:   +1-201-585-2048
Email: Ron_Aldridge@wuxiapptec.com


'/>"/>
SOURCE WuXi PharmaTech (Cayman) Inc.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. WuXi PharmaTech Announces Second-Quarter 2012 Results
2. Pharmatech Oncology Receives Phase 2 SBIR Funding for Just-In-Time Enrollment Model
3. WuXi PharmaTech Announces First-Quarter 2012 Results
4. Industry Leading Pharmaceutical News Website in-Pharmatechnologist.com Refocused and Relaunched
5. WuXi PharmaTech Files 2011 Annual Report on Form 20-F
6. Perrigo Receives FDA Approval And Commences Launch Of Clobetasol Propionate Shampoo, 0.05%
7. GeNO LLC Receives FDA Marketing Clearance For Its Inhaled Nitric Oxide Drug Delivery Device
8. First Warning Systems Receives Investment by Members of the Reno Angels and Local Investors
9. iMD Companies Inc. receives shares of Positive Solutions
10. Genelex Receives First Patent on Business Methods for Pharmacogenetics
11. AcelRx Pharmaceuticals Receives Two Additional U.S. Patents for Small-Volume Oral Transmucosal Dosage Forms
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/2/2016)... December 2, 2016 According ... Diagnostics/IVD Market by Product (Instruments, Reagents, Software), Technology ... Oncology, Cardiology, Nephrology, Infectious Diseases) - Forecast to ... valued at USD 60.22 Billion in 2016. This ... of 5.5% during the forecast period (2016-2021) to ...
(Date:12/2/2016)...  The Addiction Treatment Advisory Group (ATAG), created ... Pharmacy (AMCP), has released detailed findings on how ... addiction crisis, including through improved access to naloxone ... newly released paper, "The Role of Managed Care ... issues around gaps and barriers to addiction treatment ...
(Date:12/2/2016)... , Dec. 2, 2016 Boston Scientific ... definitive agreement to acquire certain manufacturing assets and capabilities ... (TSX: NVC) advanced biological tissue business, as well as ... of $75 million in cash. The Neovasc advanced biological ... including the Boston Scientific Lotus™ Valve System. * ...
Breaking Medicine Technology:
(Date:12/5/2016)... York (PRWEB) , ... December 05, 2016 , ... ... the ability of physical therapist assistants, under direct supervision of a licensed physical ... obtains physical therapy receives a consultation and treatment plan from a licensed physical ...
(Date:12/5/2016)... , ... December 05, 2016 , ... As renowned, board-certified ... the dangers and downsides of patients who do not do their research and undergo ... cosmetic dermatology is in the midst of a renaissance and every other month a ...
(Date:12/5/2016)... ... 2016 , ... Z-Medica, LLC, a leading developer and marketer ... College of Surgeons (ACS) to provide basic bleeding control instructor training to surgeons. ... is a pilot program that fulfills the intent of the White House’s “Stop ...
(Date:12/4/2016)... ... 03, 2016 , ... The Lymphoma Research Foundation (LRF) – ... serving the lymphoma community through a comprehensive series of education programs, outreach initiatives ... New York City, with long-time partners The Paul Foundation, on November 10, 2016. ...
(Date:12/4/2016)... ... December 03, 2016 , ... ... wins "Best Surgical Body Shaping" at the 2016 Anti-Aging & Beauty ... France. , The Aesthetic & Anti-Aging Medicine European Congress (AMEC) brings ...
Breaking Medicine News(10 mins):