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