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; THAM; Tris base; Trometamol Drug Master File in Korea (Tris(hydroxymethyl)aminomethane; THAM; Tris base; Trometamol KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Tris(hydroxymethyl)aminomethane; THAM; Tris base; Trometamol. The MFDS reviews the Tris(hydroxymethyl)aminomethane; THAM; Tris base; Trometamol KDMF as part of the drug registration process and uses the information provided in the Tris(hydroxymethyl)aminomethane; THAM; Tris base; Trometamol KDMF to evaluate the safety and efficacy of the drug.
After submitting a Tris(hydroxymethyl)aminomethane; THAM; Tris base; Trometamol 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; THAM; Tris base; Trometamol API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Tris(hydroxymethyl)aminomethane; THAM; Tris base; Trometamol suppliers with KDMF on PharmaCompass.