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