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|
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