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