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