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