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