In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a 10-Oxo-10,11-dihydro-5H-dibenzo[b,f]azepine-5-carboxamide Drug Master File in Korea (10-Oxo-10,11-dihydro-5H-dibenzo[b,f]azepine-5-carboxamide KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of 10-Oxo-10,11-dihydro-5H-dibenzo[b,f]azepine-5-carboxamide. The MFDS reviews the 10-Oxo-10,11-dihydro-5H-dibenzo[b,f]azepine-5-carboxamide KDMF as part of the drug registration process and uses the information provided in the 10-Oxo-10,11-dihydro-5H-dibenzo[b,f]azepine-5-carboxamide KDMF to evaluate the safety and efficacy of the drug.
After submitting a 10-Oxo-10,11-dihydro-5H-dibenzo[b,f]azepine-5-carboxamide 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 10-Oxo-10,11-dihydro-5H-dibenzo[b,f]azepine-5-carboxamide API can apply through the Korea Drug Master File (KDMF).
click here to find a list of 10-Oxo-10,11-dihydro-5H-dibenzo[b,f]azepine-5-carboxamide suppliers with KDMF on PharmaCompass.