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