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