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