In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a 1-oxo-2-(2,6-dioxopiperidin-3-yl)-4-aminoisoindoline Drug Master File in Korea (1-oxo-2-(2,6-dioxopiperidin-3-yl)-4-aminoisoindoline KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of 1-oxo-2-(2,6-dioxopiperidin-3-yl)-4-aminoisoindoline. The MFDS reviews the 1-oxo-2-(2,6-dioxopiperidin-3-yl)-4-aminoisoindoline KDMF as part of the drug registration process and uses the information provided in the 1-oxo-2-(2,6-dioxopiperidin-3-yl)-4-aminoisoindoline KDMF to evaluate the safety and efficacy of the drug.
After submitting a 1-oxo-2-(2,6-dioxopiperidin-3-yl)-4-aminoisoindoline 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 1-oxo-2-(2,6-dioxopiperidin-3-yl)-4-aminoisoindoline API can apply through the Korea Drug Master File (KDMF).
click here to find a list of 1-oxo-2-(2,6-dioxopiperidin-3-yl)-4-aminoisoindoline suppliers with KDMF on PharmaCompass.