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