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