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