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