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