In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Ultravist 300 Drug Master File in Korea (Ultravist 300 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Ultravist 300. The MFDS reviews the Ultravist 300 KDMF as part of the drug registration process and uses the information provided in the Ultravist 300 KDMF to evaluate the safety and efficacy of the drug.
After submitting a Ultravist 300 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 Ultravist 300 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Ultravist 300 suppliers with KDMF on PharmaCompass.