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