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