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