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