Xi'an Guokang Ruijin Pharmaceutical Co., Ltd. is the only manufacturer of glucocorticoid raw materials with GMP qualifications in northwest China. It is affiliated with Guokang Biopharmaceutical (Shenzhen) Co., Ltd. and was established in March 2018 with a registered capital of 50 million RMB.
The company acquired the pharmaceutical related business operation rights of Xi'an Ruifeng Pharmaceutical Co., Ltd. in June 2019, becoming a national high-tech enterprise specializing in the production, sales, and research and development of steroid hormone raw materials. The company is located in Jinghe Industrial Park, Xi'an City, with dense greenery and beautiful scenery. It covers an area of about 100 acres and currently employs more than 100 people, including about 30 middle and senior technical personnel; We have advanced production facilities and testing equipment, as well as multiple professional synthesis, refining, and fermentation production lines.
The company has applied for 28 intellectual property rights and granted 19 licenses, including 9 invention patents and 10 utility models. The company has good qualifications and reputation, and has passed the certification of 3A credit enterprise, 5A standardized management system, and ISO three systems (quality management, environmental management, and occupational health and safety management). Obtained the honorary certificate of industrial enterprise research and development institution evaluated by the Municipal Bureau of Industry and Information Technology in 2021; In 2022, obtained the evaluation certificate for the municipal level integrated management system of industrialization and industrialization.
It is expected to pass the provincial "specialized, special and new" SME certification in 2023.
The company currently has four types of steroid hormone raw materials: dexamethasone, dexamethasone sodium phosphate, dexamethasone acetate, and betamethasone. These four varieties have all passed national GMP certification and have a complete GMP management system. They have also obtained Indian registration certificates, laying the foundation for entering the Indian market. At present, two products, dexamethasone and dexamethasone sodium phosphate, have achieved EU CEP certification and FDA certification, entering the international high-end market.
In the future, in addition to continuously expanding the domestic and international market of existing products, the company also has a professional R & D team, dedicated to the research and development and industrial production of new products such as dydrogesterone and niergoline. The company's dydrogesterone active drug products have completed domestic registration and application in September 2021, and obtained the world's first imitation dydrogesterone registration and record, which has been publicized on the CDE registration platform. In April 2022, I completed the application of DMF data in the United States, and received the DMF registration letter from FDA in May 2022. At present, large-scale production has been achieved, and the product quality is stable. All of them meet EP, USP standards and registration standards. The company also has a reserve of more than ten prostaglandin products in the field of research, such as caprost anbutriol, plans to land in the industrialization in the next 5 years, to make contributions to the promotion of the development of Chinese pharmaceutical industry.
Enterprise spirit
Diligence and dedication, creating excellence.
Enterprise philosophy
Integrity as basis, survive on quality.
Quality policy
Continuous improvement, survive on quality; technological innovation, develop by management.
Enterprise tenet
Refined production, all for people.
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