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