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100 June 2015 Tablets & Capsules Solid Dosage SourceBook Rottendorf Pharmaceuticals Corporate Description Rottendorf Pharmaceuticals is the U.S. subsidiary of Rottendorf Pharma GmbH, a global Top 20 contract development and manufacturing organization (CDMO). The company has been developing, formulating, manufacturing, and packaging solid oral dosage forms for more than 85 years. We serve more than 200 global pharmaceutical clients and annually produce more than 600 products and well over four billion solid doses. Clients choose Rottendorf for our broad-ranging expertise, global regulatory capabilities, commitment to quality, and exceptional customer service. Areas of Excellence Under Total Process Ownership (TPO), a guiding philosophy for our client services, we assume a much higher degree of ownership than the typical CMO over the processes we use to bring clients' pharmaceuticals to market. TPO reduces your requirements for management oversight and costs, while improving the supply chain and product quality. Markets Served Rottendorf Pharmaceuticals serves the global pharmaceutical market – big, small, virtual, and emerging. Our facilities are GMP compliant and inspected by regulatory agencies worldwide, including the FDA, EMEA, ANVISA, and others. Services Analytical development Development, validation, and transfer of analytical methods; release analytics, ICH stability studies, and analytical support throughout the product manufacturing process. Rottendorf Pharmaceuticals 875 North Michigan Ave. - 31st Floor Chicago, IL 60611 Tel: 312 794 7836 Website: www.rottendorfus.com 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 for procurement of packaging materials and distribution. Facilities State-of-the art facilities are located in Ennigerloh, Germany and Valenciennes, France. The Rottendorf Development Center provides best-in-class technical equipment. It produces batches from 2kg to 150kg, while our manufacturing facilities produce batches up to 750kg.