APIs, Excipients & Packing Materials CDMF Filing with CDE
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APIs, Excipients & Packing Materials CDMF Filing with CDE
KRB RA team supported for over 100 imported and domestic APIs, Excipients & Packing Materials CDMF filing with CDE and their technical review, which includes original dossier gap analysis, project management, guidance and review and confirmation of key & major deficiency items in the gap analysis, professional document translation and CDMF dossier preparations, submission and technical review until final approval of the products. Some of products as fluticasone propionate, carbon [13C]-urea, pharmaceutical spray pump, lactose, propylene glycol monooctanoate, propylene glycol monolaurate (type II), ethanol, etc.
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