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