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