In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Nitroderm TTS-5 Drug Master File in Korea (Nitroderm TTS-5 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Nitroderm TTS-5. The MFDS reviews the Nitroderm TTS-5 KDMF as part of the drug registration process and uses the information provided in the Nitroderm TTS-5 KDMF to evaluate the safety and efficacy of the drug.
After submitting a Nitroderm TTS-5 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 Nitroderm TTS-5 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Nitroderm TTS-5 suppliers with KDMF on PharmaCompass.