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