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