In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a potassium 2,3,4,5,6-pentahydroxyhexanoate Drug Master File in Korea (potassium 2,3,4,5,6-pentahydroxyhexanoate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of potassium 2,3,4,5,6-pentahydroxyhexanoate. The MFDS reviews the potassium 2,3,4,5,6-pentahydroxyhexanoate KDMF as part of the drug registration process and uses the information provided in the potassium 2,3,4,5,6-pentahydroxyhexanoate KDMF to evaluate the safety and efficacy of the drug.
After submitting a potassium 2,3,4,5,6-pentahydroxyhexanoate KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their potassium 2,3,4,5,6-pentahydroxyhexanoate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of potassium 2,3,4,5,6-pentahydroxyhexanoate suppliers with KDMF on PharmaCompass.