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