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