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