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