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