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