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