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