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 complex Drug Master File in Korea (iron-polymaltose complex KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of iron-polymaltose complex. The MFDS reviews the iron-polymaltose complex KDMF as part of the drug registration process and uses the information provided in the iron-polymaltose complex KDMF to evaluate the safety and efficacy of the drug.
After submitting a iron-polymaltose complex 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 complex API can apply through the Korea Drug Master File (KDMF).
click here to find a list of iron-polymaltose complex suppliers with KDMF on PharmaCompass.