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