Rottendorf Pharma Inc. will initially focus its efforts on developing markets through Business Development and Supply Chain activities in the United States. These efforts will be supported by manufacturing operations in Germany and Europe initially, with plans for a US based packaging operation already on the horizon. The technical areas of Formulation, Development and Bulk Manufacturing remain in Europe for the present.
In contrast to classic Contract Manufacturing for pharmaceuticals, Rottendorf Pharma is a high end Technical Operations Organization (TOO), assuming total process ownership for every level of a complete range of services from initial formulation through full scale commercial production, including packaging and distribution. Rottendorf Pharma's core competency and specialty, since its establishment in 1928, is solid dose forms. With extensive implementation of its Operational Excellence initiative, Rottendorf Pharma has integrated continuous improvement processes with its well established strengths of pharmaceutical expertise and efficient and robust operations to deliver high quality results to an impressive list of clients.
As an expert in the development and manufacture of solid dose forms - tablets, pellets, capsules, multi-layer, sugar coated and film coated tablets, Rottendorf employs state- of- the -art technologies including hot melt extrusion and hot melt granulation. Rottendorf is fully approved for global operations and certified compliant by the FDA, EMEA/MRHA and ANVISA.
Rottendorf has successfully supplied products for the US market for the last 4 years from its FDA approved production facility in Germany. The establishment of Rottendorf Pharma Inc. is the next step in demonstrating a firm commitment to expanding the US market presence and providing "home based" services to US/American customers.