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