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:4/28/2017)... ... April 28, 2017 , ... Led by industry ... science products comes to New Orleans, Philadelphia and San Diego in 2017. The ... America and discuss local cultural nuances for working with the regulators. , This ...
(Date:4/28/2017)... Westlake Village, CA (PRWEB) , ... April 28, 2017 , ... ... diagnostics, today announced the launch of a new neoadjuvant breast cancer monitoring (NEAT) study ... include at least 10 centers and over 150 patients to be monitored over two ...
(Date:4/28/2017)... IL (PRWEB) , ... April 28, 2017 , ... While ... worked hard to restructure the company and provide a new outlook for the future. ... has decided to implement new management with the retirement of Mr. Siegel as CEO. ...
(Date:4/28/2017)... Kansas City, KS. (PRWEB) , ... April 28, ... ... functional service contract research organization (CRO) has validated a 0.2 ng/mL lower limit ... Previously having validated a 0.5 ng/mL LLOQ assay, the ultra-low trace nicotine assay ...
Breaking Biology Technology:
(Date:4/24/2017)... -- Janice Kephart , former 9/11 Commission ... LLP (IdSP) , today issues the following statement: ... 6, 2017 Executive Order: Protecting the Nation ... instilled with greater confidence, enabling the reactivation of ... are suspended by until at least July 2017). ...
(Date:4/19/2017)... 19, 2017 The global military ... is marked by the presence of several large global ... by five major players - 3M Cogent, NEC Corporation, ... for nearly 61% of the global military biometric market ... the global military biometrics market boast global presence, which ...
(Date:4/18/2017)... Inc., a global expert in SoC-based imaging and computing solutions, has ... features the company,s hybrid codec technology. A demonstration utilizing TeraFaces ® ... be showcased during the upcoming Medtec Japan at Tokyo Big Sight ... Las Vegas Convention Center April 24-27. ... Click here for an image of the ...
Breaking Biology News(10 mins):