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