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