Tianeptine

Details:

 Founded in 2007, Nanjing Faen Chemical Co., Ltd. is a national high-tech enterprise focusing on the R&D, production, sales and drug CDMO services of characteristic small molecule compounds, pharmaceutical starting materials, GMP intermediates and APIs. We have more than 150 employees, a group of R&D teams with many years of work experience and well-trained masters and doctors, complete analytical equipment, HPLC, GC, LC-MS, GC-MS, NMR and other analytical equipment, and a production plant that meets GMP standards , Ltd., which can quickly respond to customer needs in route design and screening, process optimization, process scale-up and large-scale production.  

      Factory covering an area of 50,000 square meters, with two modern multi-functional synthesis workshops, one hydrogenation workshop, one 100,000-level clean workshop, two Class A dangerous warehouses and one Class C warehouse; The 1000 square meter testing center is located on the third floor of the comprehensive building, with complete equipment and equipment, and the entire plant is designed, built and operated in accordance with the GMP system.

    The multi-functional synthesis workshop has a total of three floors, with reference to the international modern pharmaceutical plant design concept, three or four reactors in one room, the physical partition avoids cross-contamination of materials and mixed dishes, the height difference between the three-layer reactor and the two-layer reactor, relying on gravity flow for material transmission, environmental protection and energy saving, and improving production efficiency; According to the process requirements, the production unit is quickly established by using hose connection to achieve the purpose of closed and flexible production, which provides a hardware guarantee for the rapid scale-up of small molecule compounds from R&D to commercialization. Each reactor adopts an automatic temperature control system (TCU), the temperature and pressure signals are connected to the DCS, and the hazardous process reactor is equipped with a SIS system; The centrifuge adopts automatic scraper under the discharge or horizontal centrifuge, on-line oxygen content detection, nitrogen protection, and is also equipped with an on-line automatic cleaning system; The drying equipment adopts a double cone dryer and a vacuum oven to meet the needs of closed production; At the same time, each drying equipment has an independent room to avoid cross-contamination and material mixing; All production areas and storage areas are equipped with automatic alarm detectors for toxic and combustible gases and interlock with exhaust fans, so that the whole system is safe, efficient and compliant; At the same time, the 100,000-level clean room of 400 square meters is equipped with 100L and 1000L reactors, centrifuges and drying equipment, which can meet the production needs of clinical APIs.

    The reactions that can be carried out in the workshop include: bromination reaction, oxidation reaction, azide reaction, diazotization reaction, chlorination reaction, Grignard reaction, high-pressure ammoniation (9MPa), high-pressure hydrogenation (10MPa), continuous flow reaction, high vacuum distillation (-0.1MPa), etc.; Equipped with automatic temperature control unit (TCU): -80°C~280°C, distributed control system (DCS), safety instrumented system (SIS), gas detection report