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