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