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