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