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