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