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