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