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