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