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