Formulation R&D Platform
- Experience in research and development, process conversion, clinical trials and registration of multiple products of chemical pharmaceutical preparations. The dosage forms involved are: oral solid preparations (tablets, capsules, granules, dry suspensions, enteric-coated pellets, oral compound preparations, etc.), oral liquid preparations (oral solutions, syrups, etc.), injections (small volume injections) Liquid, large-volume injection, freeze-dried powder injection, sterile powder injection), external preparation (ointment, gel, solution, suppository), etc.
- Registration in CDE, conduct supplementary research and comment response based on review comments, and receive experience in research and development and production site inspections.
- Focus on the combination of laboratory process research and development and factory industrialization equipment, avoid repeated investment and waste, pay attention to production cost control, and take into account the environmental pressure of production enterprises, and have rich experience in the industrialization of various formulations from the laboratory to the factory.
- Good at solid preparation powder direct compression, wet granulation, one-step granulation, dry granulation, hot melt extrusion, extrusion spheronization granulation, high-speed tableting, capsule filling, etc., injection freeze drying process and Sterilization process is preferred, emulsification process for external preparations, etc.
- The formulation research and development platform has established a long-term strategic cooperation with the international clinical trial CRO. All operations meet the requirements of GCP and relevant national regulations, and have passed the on-site verification by the national bureau many times, which can realize pharmaceutical research and development plus clinical trials (including BE) Integrated services.
- The company has more than 400 sets of various synthesis, preparation and analysis equipment, and has a complete set of synthesis and preparation pilot/pilot research and development equipment, including rotary evaporator, glass reactor, liquid phase preparation, fluidized bed, and granulator , Tablet press, coating machine, capsule filling machine, freeze dryer, etc.; various analysis and testing equipment, including LC-MS, HPLC, UPLC, GC, TGA, DSC, etc.
Beijing Hope Pharmaceutical Co., Ltd. 京ICP證000000号
