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