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