PMDA OK for NextPharma’s Belgian plant
The outsourcing company’s most recent accreditation follows the launch of a new product which required a pre-approval inspection of the cytotoxic manufacturing area, though the company already keeps a successful track record of accreditation.
In 2007, the CRO received a certificate of accreditation as a foreign manufacturer to Japan for sterile production, and earlier this year, NextPharma was approved by the French Ministry of Research to carry out R&D activities for French companies.
Bill Wedlake, CEO of NextPharma Technologies, which specialises in aseptic production and packaging, including the manufacturing of cytotoxic products, said the recent accreditation “is a very pleasing result and follows the FDA’s formal confirmation of regulatory approval of our sterile cytotoxic manufacturing operations.
“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,” he added.
