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