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