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