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