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