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