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