Municipal Key Project Observation Team to Investigate in Tianrui Pharmaceuticals
Time:
2020-07-30
Change the dust-free clothes, put on the working cap, footwear, wash hands and disinfect, and then go through three doors, in order to take a glance at the pharmaceutical production line through the glass window.
Change the dust-free clothes, put on the working cap, footwear, wash hands and disinfect, and then go through three doors, in order to take a glance at the pharmaceutical production line through the glass window.
Yichang Renfu Pharmaceutical, Renfu Pharmaceutical core subsidiary, the national narcotic drugs designated R & D and production enterprises, the main products are fentanyl, remifentanil and sufentanil, alfentanil raw materials and preparations, narcotic drugs accounted for 60% of the domestic market share.
Bottle washing, washing plugs, canning, freeze-drying, capping ...... November 22, Yichang High-tech Zone, Dongshan Park, Yichang Renfu Pharmaceuticals freeze-dried emulsion workshop, metal pipeline intertwined, a box of remifentanil is on the production line “sprinting”.
Lyophilized emulsion workshop supervisor, process engineer Luo Changyi introduction, the production line since 2011, with a total investment of more than 200 million yuan, in full accordance with the U.S. FDA and the European Union EMA standards for design, construction and acceptance, automatic feeding, automatic filling and other advanced equipment are imported from Germany, Italy, Japan, the United States.
“Capping process can be 600 bottles per minute, filling process 520 bottles per minute.” Luo Changyi said, compared with the same type of pharmaceutical production line, the line optimized the production process, upgraded equipment, production labor from seven or eight people down to two or three people, production efficiency has increased significantly.
It is also reported that the company also invested nearly ten million yuan, the establishment of an advanced data collection system and production execution system, through intelligent means, to achieve the automatic collection of production data and production records electronically, to enhance the timeliness, accuracy and traceability of the data, to better ensure product quality.
The “new” is not only the equipment and information system, but also the entire pharmaceutical quality system. In the view of the enterprise, product quality is the foundation of pharmaceutical enterprises, but also the core competitiveness to enter the international market.
In 2015, Yichang Renfu Pharmaceutical's first internationalization project, the export base, was put into operation; in 2016, the project passed the FDA on-site inspection with zero defects, and the first batch of preparation products were sold to the U.S. in the same year; in 2018, the company's overall quality management system passed the MHRA certification in the U.K., and it plans to In 2018, the company's overall quality management system passed the MHRA certification in the UK, and plans to have all raw materials and preparation production lines certified by the U.S. and the EU during the “14th Five-Year Plan” period, realizing the overall quality upgrade.
Innovation is indispensable for pharmaceutical companies to realize sustainable high-quality development.
At present, Renfo Pharma has set up R&D centers in Wuhan, Yichang and New Jersey, bringing together more than 1,600 professional pharmaceutical R&D personnel, including 191 PhDs and 8 experts enjoying the State Council's special allowances, and has also cooperated with the Chinese Academy of Sciences, Tsinghua University, Wuhan University, Fudan University, and the Third Hospital of Peking University, to promote the incubation of innovations with the impetus of technological platforms and cooperation between the industry, academia, and research institutes.
“At present, we are carrying out the research and development of several new drugs, and during the '14th Five-Year Plan' period, we will also invest in the completion of new projects such as Yichang Renfu Pharmaceuticals' global headquarters base and high-end API base.” Yichang Renfu Pharmaceutical production management head, vice president Zhong Lijun said, the company will build the headquarters base project to become the world's most advanced anesthesia, psychotropic drugs R & D and production base, the API base is mainly to produce high-value-added API products, to enhance the industry chain, the supply chain of the independent and controllable capacity.
Background link] Nearly 20 new Class 1 drugs under development to meet more clinical needs
The research and development of Class 1 chemicals is an important benchmark for measuring a region's innovation capability and industry level. Up to now, three new drugs have been approved as chemical class 1 innovative drugs in our province, of which Renfo Pharmaceuticals has accounted for two.
In July 2020, Renfo Pharmaceuticals Rimazolam Benzenesulfonic Acid for Injection was approved as the first chemical 1 new drug in the province, breaking the situation that no innovative drugs have been listed in the field of domestic and foreign clinically widely-used sedative drugs in the past 30 years; in May this year, Renfo Pharmaceuticals once again “captured” a chemical 1 new drug, Phosphopropofol Disodium for Injection.
Aiming at cutting-edge technology, meeting unmet clinical needs, and continuously developing more new drugs and good drugs to improve the level of patients' medication and improve people's quality of life, this is the original intention of Renfo's innovative drug research and development. At present, Renfo Pharma has more than 200 products under research and development, and nearly 20 Class 1 new drugs under research and development. It has 563 authorized patents and 37 international patents, covering Europe, the United States, Japan and other countries and regions.
Reporter's Note] “Craftsmanship” drives innovation and quality
Pharmaceuticals are related to the health of the general public, requiring pharmaceutical companies and practitioners to uphold the “craftsmanship”, product refinement, excellence, to ensure that the supply of drugs, and constantly improve the quality.
The research and development of innovative medicines is not a one-day process, but may take as little as six years or as long as ten years or more, which requires enterprises and practitioners to make efforts to improve the quality of medicines in the future.
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