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