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 succinate Drug Master File in Korea (alpha-tocopherol succinate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of alpha-tocopherol succinate. The MFDS reviews the alpha-tocopherol succinate KDMF as part of the drug registration process and uses the information provided in the alpha-tocopherol succinate KDMF to evaluate the safety and efficacy of the drug.
After submitting a alpha-tocopherol succinate 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 succinate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of alpha-tocopherol succinate suppliers with KDMF on PharmaCompass.