NextPharma Technologies Completes Expansion Of Its Waltrop Semi-Solids Hormones Facility In Germany
NextPharma, the leading European provider of product development, contract manufacturing and cold chain and logistics outsourcing services to the pharmaceutical and biotechnology industries, is pleased to announce that it has completed the expansion of its semi-solid hormones facility in Waltrop Germany.
The expansion extends Waltrop's capabilities through the addition of solid and semi-solid production to its dedicated hormone facility (operational since August 2005) with state of the art contained production areas, separate personnel and material lockers and separate air conditioning systems. The production unit manufactures three classes of hormonal substances: sexual hormones, corticosteroids and thyroid gland hormones.
The new hormone semi-solids area comprises of a surface area of 240 m², one bulk production room, three packaging rooms and a cleaning area. It also houses a new Becomix RW 1200 CD processing mixer with a 1,200 litre production vessel. The area's packaging capabilities include suppositories, pessaries, ointments, creams and gels in aluminium tubes and canisters, and stick packs.
Dr. Hermann Osterwald, Managing Director, NextPharma Technologies, Contract Manufacturing Services commented: "Following on from the success of our hormone solids area which was completed in 2005, we are delighted to have expanded our capabilities to include hormone semi-solids manufacturing and to be in a position to offer existing and new customers the benefits of this new facility. This addition to our capabilities is another important step towards NextPharma's objective to be the leading provider of contract manufacturing services to the global pharmaceutical and biotechnology markets".
NextPharma Waltrop is FDA inspected and has extensive know how in development, contract manufacturing, packaging, quality control and logistics of hormonal products as well as conventional dosage forms (liquids and semi-solids). Waltrop has established an excellent reputation as a hormone specialist and also has expertise in manufacturing and packaging oral contraceptives. Additionally, Waltrop has established itself as a specialist for pump sprays for topical liquids in conventional dosage form production and can provide film coating of pellets as a ‘back-up' to NextPharma Bielefeld.
Waltrop Product Development Services can provide formulation and analytical development for a complete range of oral and topical products with conventional and hormonal Active Pharmaceutical Ingredients (APIs) and New Chemical Entity (NCE) to Phase II clinical trials with scale-up capability to Phase III and commercial scale on the same site, in accordance with the highest regulatory requirements.
NextPharma Waltrop Logistics operates from two distribution zones of 1,500 m².Its services and capabilities include being a center of excellence for controlled temperature storage and distribution services, independent of wholesalers, pick-by-light system and scan technology, storage of controlled substances, storage 15-25°C, 2-8°C and at -20°C and temperature controlled storage and manufacturing authorisation.
NextPharma develops, manufactures, packages, and distributes a broad range of products and formulations for its customers from tablets and capsules to antibiotics, hormones and controlled release medicines. It has an established leadership position in the high technology area of injectables manufacturing, with particular expertise in pharmaceutical development and manufacture of oncology medicines.
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.
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.
SOURCE: NextPharma