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