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