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