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