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