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