In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a IMX-150 Drug Master File in Korea (IMX-150 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of IMX-150. The MFDS reviews the IMX-150 KDMF as part of the drug registration process and uses the information provided in the IMX-150 KDMF to evaluate the safety and efficacy of the drug.
After submitting a IMX-150 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 IMX-150 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of IMX-150 suppliers with KDMF on PharmaCompass.