In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a magnesium(2+) hydroxide Drug Master File in Korea (magnesium(2+) hydroxide KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of magnesium(2+) hydroxide. The MFDS reviews the magnesium(2+) hydroxide KDMF as part of the drug registration process and uses the information provided in the magnesium(2+) hydroxide KDMF to evaluate the safety and efficacy of the drug.
After submitting a magnesium(2+) hydroxide 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(2+) hydroxide API can apply through the Korea Drug Master File (KDMF).
click here to find a list of magnesium(2+) hydroxide suppliers with KDMF on PharmaCompass.