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