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Technology Department
We have a research and development team composed of many masters and many engineers and technicians with rich experience in organic chemical synthesis and analysis.Perfect instruments and equipment: advanced detection instruments such as HPLC, GC, IR, etc.; synthesis equipment such as low-temperature reactor, rotary evaporator, kilogram reactor, etc.; and other experimental devices. At the same time, a modern pilot plant has been built.An open and orderly project management and assessment system with project as the core and progress as the axis, and a free and open R&D atmosphere。
R&D capability
At present, the Technology Department is mainly engaged in the research and development of APIs and chemical intermediates. In addition to conventional organic synthesis, the Technology Department can also carry out various special unit reactions such as anhydrous, oxygen free, low-temperature and unstable compound operations. Good experimental conditions and perfect testing equipment enable the Technology Department to carry out various chemical synthesis experiments from gram to kilogram and small and medium-sized tests of new products, and assist the Production Department to complete the commercial production of multiple products。R&D direction
Antidepressant and antipsychotic drugs: imitation of the products whose patents are expired or about to expire, such as Salotene (paroxetine hydrochloride), Zolof (sertraline hydrochloride), Lanfu (fluvoxamine), Venlafaxine hydrochloride, Minapram hydrochloride, etc. Antibiotics: develop new third-generation and fourth generation cephalosporins based on the existing cefepime and cefpirome, mainly including cefdinir and cefixime、cefoselis、cefuzonam、cefpiramide、cefluprenam、Cefaclidine、cefodizime。Pharmaceutical intermediates: develop supporting intermediates for the products of the company and international famous pharmaceutical enterprises, and accept customized synthesis from customers。Future development
The Technology Department aims to promote the strategic development of the company and is oriented to meet the needs of the market and customers. We emphasize the speed and quality of development, vigorously develop in the field of generic APIs and customized synthesis, and develop a series of drugs for the benefit of the people. At the same time, the Technology Department has continuously strengthened the contact and communication with many well-known chemical pharmaceutical companies at home and abroad, strengthened the cooperation with famous universities and scientific research institutions at home and abroad, and realized technical exchange and resource sharing。
Production Department
Adhering to the CGMP concept, the production system highly fulfills the responsibilities of the department, adheres to clean and civilized production, lean and efficient, and strives for excellence, making unremitting efforts to build the company's concept of "producing first-class products and devoting to human health"。
Management features of production system：
1．Create a learning team. In the final analysis, the market competition is the competition for talents. In order to continuously improve the quality of employees, the production system pays attention to the further improvement of the learning ability of employees, regularly conducts CGMP knowledge training for all employees, irregularly holds various and interesting on-site training according to the actual needs, and irregularly sends key personnel to participate in the external centralized training of the company according to the development plan。
2．Insist on the idea of safety first. Safety is more important than Mount Tai. The production system is operated in strict accordance with the company's safety management network. The safety management system is perfect. The production plants and equipment are protected in accordance with the specifications; All employees shall take their posts after passing the three-level safety education; Employees are equipped with complete safety protection articles during production。
3．Adhere to the concept that quality is the life of the enterprise. The production system has a sound production quality management system and standardized production quality assurance documents. The production system applies CGMP idea to the whole process of production control, and effectively monitors the whole process from the input of raw materials to the output of API; The cleaning of key equipment, process water system, air conditioning system and production process shall be verified and re verified regularly to control deviation and confusion to the maximum extent。
Production system qualification
The existing employees of the production system have college degree or above in pharmacy or related majors, many of them have obtained intermediate or above technical titles, and key posts are equipped with national licensed pharmacist qualification personnel. At present, an API workshop has been officially put into use, specializing in the production of antipsychotic APIs. The products are oriented to the international market. At present, the company's product citalopram hydrobromide has been obtained from the US FDA DMF No., similar products of the company are applying for FDA certification in succession; The large semi synthetic cephalosporin project that the company is spending huge amounts of money on is under preparation. The company uses the internationally advanced solvent crystallization process, puts two production lines for cephalosporin synthesis, sterile and non sterile cephalosporin APIs at one time, and uses the domestic advanced new high-efficiency energy-saving filter equipment to ensure the supply of high-quality and inexpensive products to the market。