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