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GEN News Highlights : Sep 11, 2007

Debiopharm Receives cGMP Certification for QC of Drug Products

Swiss decision covers Gland laboratory.

Debiopharm achieved cGMP certification from Swissmedic for the chemical, physical, and biochemical quality control work conducted at its laboratory in Gland, Switzerland. Debiopharm now has the alternative to handle its analytical development, formulation, and quality control activities in-house when necessary, according to Kamel Besseghir, CEO.

Debiopharm also has a cGMP development and production facility in Martigny, Switzerland, which has been inspected by the FDA and Swissmedic. The company reports that it can produce pilot batches of cGMP drug products for feasibility studies, clinical trial supplies, and commercial-scale manufacturing.