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