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