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