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.
Contact:
Dr. Hermann Osterwald Managing Director CMS NextPharma Phone: +49 551 382 105 Mobile: +49 171 558 969 0 Email: hermann.osterwald@nextpharma.de
Bill Wedlake Chief Executive Officer NextPharma Technologies Holding Limited Tel +44 (0) 1483 479 121 www.nextpharma.com
