mitomycin Injection 40 mg
Dossier type
US CTD
Dossier status
Ready to file
Country of origin
China
GMP approvals
China
Manufacturer #18656
This China-based firm provides comprehensive regulatory and market-entry services for pharmaceutical products, offering support that spans API and finished-dosage registration, DMF and CTD preparation, clinical and marketing-authorization submissions, and the sourcing and registration of APIs, reference substances, impurities, excipients, and intermediates, while also delivering translation, dossier development, and quality-review services that assist any pharmaceutical manufacturer seeking compliance within the Chinese market.
Manufacturer usually replies in 43 days
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