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