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