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