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