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