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