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