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