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