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