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