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