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