In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a (3R,4S,5S,6R)-6-(hydroxymethyl)oxane-2,3,4,5-tetrol Drug Master File in Korea ((3R,4S,5S,6R)-6-(hydroxymethyl)oxane-2,3,4,5-tetrol KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of (3R,4S,5S,6R)-6-(hydroxymethyl)oxane-2,3,4,5-tetrol. The MFDS reviews the (3R,4S,5S,6R)-6-(hydroxymethyl)oxane-2,3,4,5-tetrol KDMF as part of the drug registration process and uses the information provided in the (3R,4S,5S,6R)-6-(hydroxymethyl)oxane-2,3,4,5-tetrol KDMF to evaluate the safety and efficacy of the drug.
After submitting a (3R,4S,5S,6R)-6-(hydroxymethyl)oxane-2,3,4,5-tetrol 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 (3R,4S,5S,6R)-6-(hydroxymethyl)oxane-2,3,4,5-tetrol API can apply through the Korea Drug Master File (KDMF).
click here to find a list of (3R,4S,5S,6R)-6-(hydroxymethyl)oxane-2,3,4,5-tetrol suppliers with KDMF on PharmaCompass.