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