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