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