BioSpace.com

Biotech and Pharmaceutical
News & Jobs
Search the Site
 
   
Biotechnology and Pharmaceutical Channel Medical Device and Diagnostics Channel Clinical Research Channel BioSpace Collaborative    Job Seekers:  Register | Login          Employers:  Register | Login  

NEWSLETTERS
Free Newsletters
Archive
My Subscriptions

NEWS
News by Subject
News by Disease
News by Date
PLoS
Search News
Post Your News
JoVE

CAREER NETWORK
Job Seeker Login
Most Recent Jobs
Browse Biotech Jobs
Search Jobs
Post Resume
Career Fairs
Career Resources
For Employers

HOTBEDS
Regional News
US & Canada
  Biotech Bay
  Biotech Beach
  Genetown
  Pharm Country
  BioCapital
  BioMidwest
  Bio NC
  BioForest
  Southern Pharm
  BioCanada East
  US Device
Europe
Asia

DIVERSITY

INVESTOR
Market Summary
News
IPOs

PROFILES
Company Profiles

START UPS
Companies
Events

INTELLIGENCE
Research Store

INDUSTRY EVENTS
Biotech Events
Post an Event
RESOURCES
Real Estate
Business Opportunities

 News | News By Subject | News by Disease News By Date | Search News
eNewsletter Signup
Miles
Km80.5

   

Novasep's Pharmaceutical Production Excellence in Europe and the Bahamas Recognized by Two Successful FDA Inspections in 2011


7/27/2011 9:37:48 AM

Pompey, France, July 27, 2011 – Novasep, a leading supplier of manufacturing solutions to the life sciences industries, announces today that it has completed two successful US Food and Drug Administration (FDA) inspections for Novasep Synthesis in 2011. All five Novasep Synthesis sites passed FDA inspections in the last three years, the most recent ones at its Freeport (the Bahamas) facility in March 2011 and at its Chasse sur Rhône (Lyon, France) facility in May 2011 prompting no remarks.

Between 2007 and 2009 an average of only 11 percent of API producers – 107 out of 920 FDA registered products – were inspected in China, and approximately 33 percent in other regions, including India and Europe (source US Government Accountability Office). In contrast, with 100 per cent of the Novasep production sites inspected successfully in the last three years, Novasep resides in the top tier of CMOs, providing a high degree of quality assurance and security of supply to its customers.

“Our ability to continuously meet and exceed the FDA (and the EMA, its European equivalent) requirements is as important as our technology leadership in purification and synthesis. We will maintain our production track record and our continued commitment to quality,” said Patrick Glaser, president of Novasep Synthesis, the synthetic molecule contract manufacturing division of Novasep. “Our unique scope of synthesis and purification technologies and know-how enables us to efficiently produce the increasingly complex molecules of today and tomorrow at the highest level of purity, and Novasep is the only company that combines this expertise with such an excellent quality and regulatory track record.”

Novasep currently produces approximately 40 commercial APIs and multiple cGMP intermediates. Also, it provides purification and synthesis process development and scale-up services for approx 50 new APIs in development every year, produced in Europe and the Bahamas with the highest level of efficiency and compliance.

About Novasep

Novasep develops, markets and operates innovative technologies providing life science industries with safe and cost-effective production of active molecules. The global manufacturing solutions offered by Novasep include process development services; purification equipment and systems; contract manufacturing services; and complex active molecules. The applications of Novasep's offering cover the pharmaceutical, biopharmaceutical, food, functional ingredients and bio-industries markets. http://www.novasep.com

Mark Tidmarsh

ANDREW LLOYD & ASSOCIATES

http://www.ala.com

mark@ala.com

Brighton Business Centre 95 Ditchling Road Brighton BN1 4ST ENGLAND

Tel: +44 1273 675100

Fax: +44 1273 675400

55 rue Boissonade 75014 Paris FRANCE

Tel: +33 1 56 54 07 00

Fax: +33 1 56 54 07 01

INTERNATIONAL TECHNOLOGY MARKETS, STRATEGY & COMMUNICATION



Read at BioSpace.com

   

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES