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news.FDA has Classified Capsugel’s France facility Ploermel as acceptable to manufacture Naproxcinod, following a new drug application filing by a Capsugel customer. Capsugel, a division of Pfizer, is a hard capsule manufacturer and an innovator in drug delivery systems.
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Capsugel claimed that its France facility Ploermel provides clinical trial and commercial pharmaceutical product manufacturing services to customers around the world.
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.
Carl Mourisse, vice president and general manager of Europe, Middle East, Africa & South Asia for Capsugel, said: “We have built a unique value proposition that offers a complete solution for our partners, from concept to market.
“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.”