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