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