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 Drug Master File in Korea (Lapatinib Ditosylate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Lapatinib Ditosylate. The MFDS reviews the Lapatinib Ditosylate KDMF as part of the drug registration process and uses the information provided in the Lapatinib Ditosylate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Lapatinib Ditosylate 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 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Lapatinib Ditosylate suppliers with KDMF on PharmaCompass.