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