In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Imatinib Mesylate,Gleevec,Glivec,CGP-57148B,STI-571 Drug Master File in Korea (Imatinib Mesylate,Gleevec,Glivec,CGP-57148B,STI-571 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Imatinib Mesylate,Gleevec,Glivec,CGP-57148B,STI-571. The MFDS reviews the Imatinib Mesylate,Gleevec,Glivec,CGP-57148B,STI-571 KDMF as part of the drug registration process and uses the information provided in the Imatinib Mesylate,Gleevec,Glivec,CGP-57148B,STI-571 KDMF to evaluate the safety and efficacy of the drug.
After submitting a Imatinib Mesylate,Gleevec,Glivec,CGP-57148B,STI-571 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 Imatinib Mesylate,Gleevec,Glivec,CGP-57148B,STI-571 API can apply through the Korea Drug Master File (KDMF).
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