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