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