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