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