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