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