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