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