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