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