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