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