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