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