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