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