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