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