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