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