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