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