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