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