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