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