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