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