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