In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Revlimid, Lenalidomide, CC-5013 Drug Master File in Korea (Revlimid, Lenalidomide, CC-5013 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Revlimid, Lenalidomide, CC-5013. The MFDS reviews the Revlimid, Lenalidomide, CC-5013 KDMF as part of the drug registration process and uses the information provided in the Revlimid, Lenalidomide, CC-5013 KDMF to evaluate the safety and efficacy of the drug.
After submitting a Revlimid, Lenalidomide, CC-5013 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 Revlimid, Lenalidomide, CC-5013 API can apply through the Korea Drug Master File (KDMF).
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