Capsugel France Facility Receives FDA Approval

L'étape de fabrication du Naproxcinod a été validée par la FDA, notamment le concept propriétaire de Capsugel qui sert au Naproxcinod (Capsugel's Licaps® Drug Delivery System). Une info sans conséquence sur l'issue du dossier, il va de soi que la validation d'un aspect du dossier n'implique pas la validation du dossier lui-même, d'autant que les réserves portent sur l'efficacité et la sécurité du composé, et non de son système de fabrication.
On pourrait aussi plus prosaïquement remarquer que si cela impliquait une validation du naproxcinod, ce ne serait sûrement pas à Capsugel de le communiquer sur son site avant un communiqué de NicOx :)

The FDA has classified Capsugel's Ploërmel, France facility, which provides clinical trial and commercial pharmaceutical product manufacturing services to customers around the world, as acceptable to produce a pharmaceutical product for distribution in the United States.

June 14, 2010 - Ploërmel, France: Capsugel, the world's leading hard capsule manufacturer and an innovator in drug delivery systems, announced the U.S. Food and Drug Administration (FDA) classified its facility in Ploërmel, France as acceptable to manufacture naproxcinod, following a New Drug Application filing by a Capsugel customer. The FDA's Pre-Approval and Good Manufacturing Practices inspection of Capsugel's facility included an inspection of Capsugel's Licaps® Drug Delivery System for liquid filled naproxcinod capsules.

"We have built a unique value proposition that offers a complete solution for our partners, from concept to market", said Carl Mourisse, Vice-President and General Manager Capsugel Europe, Middle East, Africa & South Asia. "This achievement is a tangible result of our solid commitment to providing the highest level of quality and regulatory compliance services to our biopharmaceutical customers wherever they are in the world."

Ploërmel, France is Capsugel's first FDA approved facility serving customers around the world in the areas of clinical trial and commercial pharmaceutical products manufacturing.

About Capsugel
Capsugel, a division of Pfizer Inc. with over 2,800 colleagues in thirteen locations around the world, is a global leader in innovative dosage forms and solutions for the healthcare industry. Offering a comprehensive array of products and services, from hard gelatin, softgel, and vegetarian capsules, to innovative R&D equipment and liquid formulations as part of its Licaps® Drug Delivery System, Capsugel is at the forefront of drug delivery innovation providing support to customers from formulation to final production.

Alyssa Augustine, Director of Communications for Capsugel, 908-901-6584, alyssa.augustine@pfizer.com.

Source : Capsugel

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