With this expansion Waltrop capabilities are extended through the addition of solid and semi-solid production to its hormone facility (operational since August 2005) with production areas, separate personnel and material lockers and separate air conditioning systems.
NextPharma’s new production unit is expected to manufacture three classes of hormonal substances, sexual hormones, corticosteroids and thyroid gland hormones.
NextPharma said that the new hormone semi-solids area comprises of 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.
NextPharma claimed that the Waltrop is inspected by the FDA and is known to have know how in development, contract manufacturing, packaging, quality control and logistics of hormonal products as well as conventional dosage forms (liquids and semi-solids).
NextPharma stated that 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 clinical trials.
Hermann Osterwald, managing director of contract manufacturing services at NextPharma, said: “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.