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