FESPIXON® Cream is the world's only new botanical drug for the treatment of chronic diabetic foot disease. Due to the complexity of plant-derived ingredients, chemical manufacturing and control are seen as critical to the development of new botanical drugs. During the process, we strengthen raw material control, including implementing GACP and separation and qualitative analysis of main components, to strengthen product quality control, and establish the correlation between activity and ingredients in the entire process to achieve a chain reaction of product quality, safety and energy saving.
Exclusive efficacy-oriented medicinal material GACP planting platform:
Using active/index ingredients as quality control standards, we link the efficacy and safety of the Plectranthus amboinicus medicinal herbs to the product "FESPIXON®" cream to strength the quality control of new botanical drugs.
Establish a comprehensive botanical origin identification platform
Combining comprehensive medicinal material origin identification technologies such as plant taxonomy, geography, physical and chemical identification, HPLC/TLC fingerprint identification, microscopic tissue identification, powder identification and DNA molecular identification to ensure the consistency of the quality of the medicinal herbs sources and avoid misuse/mixing.
Use state-of-art technology to ensure quality
Each batch of Plectranthus amboinicus medicinal herb is analyzed by high-end precision instruments (GC-MS, LC-MS, ICP-MS, HPLC, etc.) to ensure that the test results of pathogens, heavy metals, pesticides, mycotoxins, etc. of the medicinal materials meet international standards. At the same time, a 180-ton constant temperature and air-conditioned medicinal material storage warehouse was built to preserve medicinal materials, prevent deterioration and improve medication safety.
Organic, non-toxic, earth-friendly
Adhering to the concept of protecting the earth, we actively promote green biotechnology brands and create green value services. In addition to implementing it in office environments and factories, we also take practical actions to support friendly and non-toxic agriculture. In 2017, he invested in the establishment of "Cotton Field Organic Farm Co., Ltd.", which covers an area of 44 hectares and specializes in promoting organic farming and practicing the concept of organic, non-toxic and earth-friendly.
One-stop production - from raw materials to products
We use our unique "Plectranthus amboinicus Good Manufacturing Practice" to control plant medicinal herbs, and have established a PIC/S GMP API plant and cream preparation plant in Nanchou, Pingtung, to produce the new drug "FESPIXON®" cream in a one-stop manner, which can effectively control the production and quality of drugs.
