In view of the limited supply of raw materials, high cost and serious pollution in the traditional process of steroids starting from Diosgenin, the company adopts Phytosterols as the starting material, replaces the seriously polluting turmeric extraction process with environmentally friendly bio-fermentation technology, has the advantages of wide source of raw materials, green production process, low production cost.
This project was initiated based on the research achievements of Brother company Norchem Pharmaceutical and Beijing KYF Biotech. A number of patents have been granted to the technology, which is only 30% cost of production for traditional processes and has revolutionary technological advantages
The company shares Norchem’s R&D team and research platform. Norchem is the first domestic enterprise using phytosterols as the starting material to prepare steroid hormones and achieve industrial production and has qualified as Hunan Province Engineering Technology Research Center for Steroids as well as Hunan Province Enterprise Technology Center. Norchem has carried out technical cooperation with companies and institutions from Russia and Spain, introduced foreign advanced technology. What’s more, Norchem has established a long-term strategic cooperation with Hunan University, Central South University and other well-known domestic institutions, and recently carried out technical cooperation with the United States Green Chemistry Presidential Challenge Award winner Dr. Xie Xinkai. In terms of hardware conditions, Norchem owns equipment for research with a total value of more than 13 million yuan, and built a pilot workshop of 1000 square meters, greatly improving the successful conversion rate from small trial production to commercialization.
The R&D team was awarded as Hunan Province Enterprise Science and Technology Innovation Team, which consists of 54 technicians, including 2 senior engineers, 9 in doctor degree, 16 in master degree, and 29 in bachelor degrees, focusing on the techniques research of steroid hormones and their intermediate. Strong R&D capability grantees each research project goes effectively and smoothly.
The factory covers an area of 202676.8 m2 with 7 production workshops, including synthesis workshop, fermentation workshop, extraction workshop, along with warehouses, power workshop, sewage treatment station and other public auxiliary facilities, with a total construction area of 685,00 square meters, and equipped with reactors, fermentation tanks and three-in-one equipment.
After the project is completed and put into operation, the annual output value of 1 billion yuan can be realized, and the profits and taxes will be 200 million yuan. The company aims to build the world's leading high-end industrial platform for steroid API and intermediate products
Quality and Regulatory
The company regards product quality as life, strictly implementing cGMP, EUGMP and other regulations of quality management requirements from plant design to commercial production, establishing the quality management system covering R&D, production, quality assurance, quality control, warehousing and logistics. The former Beijing KYF biotech has twice passed the Chinese GMP inspection, obtained GMP certificates for APIs like Mifepristone，Ethinylestradiol，Levonorgestrel and Estradiol. and in May 2016 passed the FDA inspection, in August 2017 passed the FDA flight inspection again. Hunan KYF pharm will draw on such rich experience, successfully complete the international market authorization.