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