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