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