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