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