NextPharma has successfully completed a PMDA inspection resulting in continued accreditation at its Braine-l’Alleud site, near Brussels in Belgium, a specialist facility for aseptic production and packaging, including the manufacture of cytotoxic products.

The Braine-l’Alleud site had received accreditation by the Japanese regulatory authorities based on previous submissions. This most recent accreditation follows a new product launch requiring a preapproval inspection of the cytotoxic manufacturing area.

Bill Wedlake, chief executive officer, NextPharma Technologies, commented: “We are delighted that the Japanese regulatory authorities have formally visited and approved our Braine facilities. This is a very pleasing result and follows the FDA’s formal confirmation of regulatory approval of our sterile cytotoxic manufacturing operations. This very positive outcome would not have been possible without the considerable efforts of the site team and quality specialists to whom we are very grateful. This is another major step forward for NextPharma in its objective to be the leading provider of world class, quality pharmaceutical product development and contract manufacturing services to the global pharmaceutical and biotechnology markets.”