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