NextPharma claims that its Belgian site, Braine-l’Alleud, has extensive know how in aseptic production and packaging including the manufacture of cytotoxic products (lyophilization and solutions) gained over more than 15 years and a growing capability in biologics.
The current accreditation comes as a result of a new product launch requiring a pre approval inspection of the cytotoxic manufacturing area and builds on the previous accreditation which dates back to September 2007 for the manufacture of existing products.
NextPharma CEO Bill Wedlake said that they are delighted that the Japanese regulatory authorities have formally visited and approved Braine facilities.
“This is a very pleasing result and follows the FDA’s formal confirmation of regulatory approval of our sterile cytotoxic manufacturing operations,” Wedlake said.
NextPharma develops, manufactures, packages, and distributes a broad range of products and formulations for its customers including solids, liquids and semi-solid dosage forms, antibiotics, hormones and controlled release medicines.