In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a 1,4-BUTANEDIOL DIMETHANESULFONATE Drug Master File in Korea (1,4-BUTANEDIOL DIMETHANESULFONATE KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of 1,4-BUTANEDIOL DIMETHANESULFONATE. The MFDS reviews the 1,4-BUTANEDIOL DIMETHANESULFONATE KDMF as part of the drug registration process and uses the information provided in the 1,4-BUTANEDIOL DIMETHANESULFONATE KDMF to evaluate the safety and efficacy of the drug.
After submitting a 1,4-BUTANEDIOL DIMETHANESULFONATE 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 1,4-BUTANEDIOL DIMETHANESULFONATE API can apply through the Korea Drug Master File (KDMF).
click here to find a list of 1,4-BUTANEDIOL DIMETHANESULFONATE suppliers with KDMF on PharmaCompass.