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