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