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