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