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