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