Surrey, UK, 27th September 2010 - NextPharma, the leading European provider of product development, contract manufacturing and cold chain and logistics outsourcing services to the pharmaceutical and biotech industry, is pleased to announce that it has successfully completed a PMDA inspection resulting in continued accreditation at its Braine-l’Alleud site, near Brussels in Belgium, a specialist facility with extensive know how in aseptic production and packaging including the manufacture of cytotoxic products.
The Braine-l’Alleud site had already received accreditation by the Japanese regulatory authorities based on previous submissions. This most recent 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.
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”.
NextPharma’s 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 fifteen years and a growing capability in biologics.
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. It has an established leadership position in the high technology area of injectables manufacturing (lyophilized and liquid fill), with particular expertise in product development and manufacture of oncology medicines.
Contact:
Bill Wedlake Chief Executive Officer NextPharma Technologies Holding Limited Tel +44 (0) 1483 479 121 www.nextpharma.com
About NextPharma
NextPharma Technologies, headquartered in the UK and founded in 2000, is a world class outsourcing partner to the pharmaceutical and biotechnology industry.
We offer a full range of services from early phase product development, through clinical trial packaging (Phases I through III) to high volume commercial manufacturing. We are a world leader in lyophilization, sterile fill finish and pellet technologies and in specialist product manufacturing including cytotoxics, hormones, penicillins, cephalosporins and controlled drugs. Our sterile development and production offers a full range of drug delivery technologies including pre-filled syringes, vials and ampoules. Additionally we have significant expertise in paediatric drug formulation, development and manufacture. NextPharma offers ‘one-stop’ logistics solutions tailored to meet the needs of the global pharmaceutical industry under the rigid standards of cGSP/GDP regulations.
We operate globally with seven product development centres, seven manufacturing plants and six temperature controlled storage and distribution sites across Europe and North America, supplying customers in North America, Europe and Japan.
We have 1,200 employees dedicated to serving over 200 customers world wide and a customer base, which includes many of the world’s leading pharmaceutical, specialty pharma and biotech companies.
We have a proven track record in almost all pharmaceutical technologies and product forms and in addition to the specialist areas above have capabilities in solids, semi-solids, liquids, sprays and dry dosage form technologies.
All of our sites are either FDA inspected, in the process of upgrade for inspection or targeted for upgrade for inspection.
About the PMDA
Established in April 2004 the PMDA (Pharmaceuticals and Medical Devices Agency) is a Japanese regulatory agency, working together with the Ministry of Health, Labour and Welfare. Its obligation is to protect the public health by assuring safety, efficacy and quality of pharmaceuticals and medical devices. It conducts scientific reviews of marketing authorization applications of pharmaceuticals and medical devices and monitors their post-marketing safety. It is also responsible for providing relief compensation for sufferers from adverse drug reaction and infections by pharmaceuticals or biological products.
