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