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84 June 2016 Tablets & Capsules Solid Dosage SourceBook Rottendorf Pharma Corporate Description Rottendorf Pharma, a Top 20 contract development and manufacturing organization (CDMO), has been developing analytical methods and formulations, manufacturing, and packaging solid oral dosage forms for the global pharmaceutical industry for more than 85 years. The company produces more than 600 custom and generic drug products annually for big, small, virtual, and global pharmaceutical and biotechnology companies. Clients choose Rottendorf Pharma for its broad-ranging expertise, global regulatory capabilities, commitment to quality, state-of-the-art facilities, and exceptional customer service. Rottendorf Pharma GmbH Ostenfelder Str. 51 - 61 59320 Ennigerloh Germany Tel: +49 2524 268 0 Website: www.rottendorfus.com Areas of Excellence Rottendorf operates under a philosophy of Total Process Ownership (TPO), in which it works as an extension of clients' organizations, leveraging its expertise to optimize solid dosage form production. TPO reduces clients' management oversight requirements and costs, while improving the supply chain and product quality. Markets Served Rottendorf Pharma serves the global pharmaceutical market – big, small, virtual and emerging. Its facilities are GMP compliant and inspected by regulatory agencies worldwide, including the FDA, EMA, ANVISA, and others. Rottendorf does not manufacture its own brands, and therefore is never in competition with its clients. Services Analytical development Development, validation, and transfer of analytical methods; release analytics, ICH stability studies, and analytical support throughout the product manufacturing process. Formulation development Optimization, upscaling, regulatory affairs support, and development of granulates, blends, tablets, capsules, film and sugar coats, pellets and hot melt extrusion and granulates; also manufacturer of clinical trial batches for all clinical phases. Contract manufacturing All solid dose forms, including high potency products; product transfer, validation, qualification, procurement of APIs and excipients. Packaging Full range – blister packs, bottles, granulate filling, and alu-wrap ©; supply chain services from procurement of packaging materials and distribution. Facilities State-of-the-art facilities are located in Ennigerloh, Germany. The Rottendorf Development Center provides best-in- class technical equipment in line with GMP and FDA standards. It produces batches from 2kg to 150kg, while its manufacturing facilities produce batches up to 750kg.