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