• Large-Scale-Manufacturing

Large-Scale Manufacturing

Pharmaron process R&D team is highly innovative and has a proven track record coming up with the practical solutions to complex synthetic problems for small molecule APIs to make them scalable. In addition to our GMP capabilities, Pharmaron production capabilities include supporting of client requirements for medium to large scale advanced intermediates, regulatory starting materials for clinical and commercial APIs and production of non-GMP APIs for tox studies. Working with the clients, based on the clinical status of the project, Pharmaron develops processes that are expedient, fit for purpose for early development and cost effective processes for late stage and commercial projects. Pharmaron’s process R&D and manufacturing capabilities are very comprehensive, provides beginning to end services for development of new small molecule APIs. For late stage and commercial projects, our well trained and experienced process team ensures continuous improvement of processes and invents second generation synthetic routes/processes to reduce cost of goods and process time cycle. Pharmaron has dedicated process safety and EHS teams which work together with process chemistry/engineering team to make sure chemical processes developed are safe and environmental friendly. To fulfill our commitment and provide seamless services to our client, Pharmaron has state-of-the-art manufacturing facilities consisting of multi-purpose workshops, including hydrogenation facility in Tianjin and Langfang. Our multi-purpose workshops have track records of handling projects; With greater than 20 linear steps synthesis; Involving asymmetric hydrogenations, air and moisture sensitive reactions, transitional metal catalysis reactions, high/low temperatures, high pressure and oxidations/reduction reactions; On larger scale for advanced intermediates, regulatory SMs ( > 5 MT). The production facility equipped with; Glass-lined/Stainless steel reactors with the size ranging from 200 – 3,000 L; Hydrogenation workshop with high operating pressure; Cryogenic systems which could handle to as low as -80oC and the high temperature system can reach to greater than 200o. Manufacturing facility expansion: To further enhance and significantly increase our current capabilities, a new larger multipurpose manufacturing facility is being built in Tianjin. It is expected to be fully operational in 2016.