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