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