Navigation Links
Debiopharm Receives cGMP Certification for Quality Control of its Drug Products
Date:9/11/2007

LAUSANNE, Switzerland, September 11 /PRNewswire/ -- Debiopharm Group (Debiopharm), a global independent biopharmaceutical development specialist in oncology and serious medical conditions, today announced that it received current Good Manufacturing Practices (cGMP) certification from Swissmedic for the chemical, physical and biochemical quality control work conducted at its laboratory in Gland, Switzerland. At the same time, certification of the Lausanne site was extended for the manufacture of medicinal products, including the packaging of investigational medicinal products. This achievement gives Debiopharm the alternative to handle its analytical development, formulation and quality control activities in-house when necessary.

"This certification is very important for the optimal development of our products," said Kamel Besseghir, CEO of Debiopharm. "Our laboratory in Gland is the internal quality reference for our outsourced activities in CMC (chemistry, manufacturing and control). We now have more flexibility and reactivity in CMC development, analysis and supply of drug products for clinical studies, one of our major strengths."

Debiopharm also has a cGMP development and production facility in Martigny, Switzerland, which has been inspected by the United States Food and Drug Administration (FDA) and Swissmedic. The company can produce pilot batches of cGMP drug products for feasibility studies, clinical trial supplies and commercial scale manufacturing.

About Debiopharm Group

Debiopharm Group is a global biopharmaceutical development specialist that in-licenses promising biologics and small molecule drug candidates. Debiopharm develops its products for global registration and maximum commercial potential for out-licensing to pharmaceutical partners for sales and marketing. Debiopharm independently funds the worldwide development of all of its products while providing expertise in pre-clinical and clinical trials, manufacturing, drug delivery and formulation, and regulatory affairs.

Founded in 1979 and headquartered in Lausanne, Switzerland, Debiopharm has developed three products with global combined sales in excess of $2.6 billion in 2006.

For more information on Debiopharm Group, please visit: http://www.debiopharm.com.


'/>"/>
SOURCE The Debiopharm Group
Copyright©2007 PR Newswire.
All rights reserved

Related biology technology :

1. Medical College receives $377K to study brain disease
2. Lucigen receives $750K grant to boost biofuel yields
3. Medical College receives $1.4M cancer grant
4. Wisconsin biotech firm receives $107K NIH grant
5. InvivoSciences receives NIH grant for heart technology
6. Medical College receives $11 million grant to study high blood pressure
7. Madison business receives $115,000 of new state biofuels funding
8. Superior receives funds for technical training
9. UWM receives state funding for plastics research
10. GEs Centricity EHR receives federal certification
11. WHIE receives state eHealth Initiative contract
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... ... 2016 , ... While the majority of commercial spectrophotometers and fluorometers use the ... models are higher end machines that use the more unconventional z-dimension of 20mm. ... the bottom of the cuvette holder. , FireflySci has developed several Agilent flow ...
(Date:6/23/2016)... , June 23, 2016 /PRNewswire/ - FACIT has ... Ontario biotechnology company, Propellon Therapeutics Inc. ... and commercialization of a portfolio of first-in-class WDR5 ... targets such as WDR5 represent an exciting class ... in precision medicine for cancer patients. Substantial advances ...
(Date:6/23/2016)... 2016  The Biodesign Challenge (BDC), a university competition ... harness living systems and biotechnology, announced its winning teams ... New York City . The ... projects at MoMA,s Celeste Bartos Theater during the daylong ... senior curator of architecture and design, and Suzanne ...
(Date:6/23/2016)... 2016 Apellis Pharmaceuticals, Inc. today announced ... of its complement C3 inhibitor, APL-2. The trials ... dose studies designed to assess the safety, tolerability, ... in healthy adult volunteers. Forty subjects ... single dose (ranging from 45 to 1,440mg) or ...
Breaking Biology Technology:
(Date:5/16/2016)... --  EyeLock LLC , a market leader of iris-based ... IoT Center of Excellence in Austin, Texas ... embedded iris biometric applications. EyeLock,s iris authentication ... with unmatched biometric accuracy, making it the most proven ... platform uses video technology to deliver a fast and ...
(Date:4/28/2016)... First quarter 2016:   , Revenues amounted to ... of 2015 The gross margin was 49% (27) ... operating margin was 40% (-13) Earnings per share rose ... was SEK 249.9 M (21.2) , Outlook   ... The operating margin for 2016 is estimated to exceed ...
(Date:4/15/2016)... 15, 2016 Research and ... Biometrics Market 2016-2020,"  report to their offering.  , ... , ,The global gait biometrics market is expected ... the period 2016-2020. Gait analysis generates ... be used to compute factors that are not ...
Breaking Biology News(10 mins):