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