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