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