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