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