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