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