The company is one of the major suppliers of L-carnitine in the world. L-carnitine produced by the company was jointly evaluated as a national key new product by the Ministry of Science and Technology of the People's Republic of China. In addition, the company participated in the formulation of the National Food Safety Standard - Food Additive L-Carnitine Tartrate (GB25550-2010), and edited three "Made in Zhejiang" group standards, namely, Food Nutrition Fortifier L-Carnitine (L-Carnitine) (T/ZZB0684-2018), Acetyl L-Carnitine Hydrochloride (T/ZZB0682-2018), and L-Carnitine Fumarate (T/ZZB0683-2018). The company's L-carnitine series products are exported to more than 30 countries around the world, and have passed ISO9001 quality system, ISO14001 environmental management system, OHSAS18001 occupational health and safety management system certification, food safety system certification (FSSC) 22000, Kosher (Kosher certification), HALAL system certification (Halal certification) and FAMI-QS system certification (quality and feed safety management system) for many times, with stable quality, It has a good international reputation.
The commercial sale of API products can only be carried out after the drug registration review and approval are completed in the country to be listed. At present, the company has completed drug registration and commercialized the bulk drug products, including L-carnitine and L-carnitine hydrochloride. The company's L-carnitine products have been registered and approved in the United States, Japan, the European Union, Canada, Greece, Italy, the United Kingdom, Malta, India and other countries, and the pharmaceutical L-carnitine hydrochloride has been registered and approved in Japan. Zoocarnitine products have passed the on-site inspection of the US FDA three times in 2013/2016/2020, and passed the on-site inspection of domestic GMP in 2021; The pharmaceutical L-carnitine hydrochloride passed the on-site inspection of PMDA in Japan in 2015, and the product quality was generally recognized by the international community. In addition, the company also actively develops other API products and accepts customization services of API products from domestic and foreign pharmaceutical enterprises to meet the registration requirements of domestic and foreign customers.
The company has accumulated more than 20 years of experience in project research, project development, pilot scale test, commercial production, registration and other sub sectors such as anti-cancer pharmaceutical intermediates, anti-virus pharmaceutical intermediates, anti infection pharmaceutical intermediates, cardiovascular pharmaceutical intermediates, which can meet the market needs of different customers.
The company is mainly committed to providing CDMO services for key pharmaceutical intermediates for multinational pharmaceutical enterprises and pharmaceutical research and development institutions. Since its establishment, the company has been committed to the field of pharmaceutical CDMO, providing customers with services such as process development and optimization, quality research and customized production of key pharmaceutical intermediates in clinical trials (including preclinical, clinical I/II/III stages) and commercialization stages. After more than 20 years of accumulation, the terminal drugs served by the company involve anti-tumor, AIDS, hepatitis B, hepatitis C, myelofibrosis, epilepsy, Parkinson's disease and other treatment fields. The terminal customization customers of the company include Incyte, Helsin, Lilly/Evonik, Gilead, GSK and other multinational pharmaceutical enterprises.
Listed on GEM of Shenzhen Stock Exchange
The teachers and students of Pharmaceutical Synthesis Technology Institute of Zhejiang University of Technology, Party Branch of Chengda Pharmaceutical Co., LTD., and the first Party branch "Party Building Community" signed a cooperation agreement.
Passed the evaluation and acceptance of Jiaxing Municipal Green Park and factory
Established a holding subsidiary, Shanghai Ruiqi Yuan Biotechnology Co., LTD