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