In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Jtk 303 Drug Master File in Korea (Jtk 303 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Jtk 303. The MFDS reviews the Jtk 303 KDMF as part of the drug registration process and uses the information provided in the Jtk 303 KDMF to evaluate the safety and efficacy of the drug.
After submitting a Jtk 303 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 Jtk 303 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Jtk 303 suppliers with KDMF on PharmaCompass.