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