Pharmamarketeer

Indian pharma companies grab 290 final ANDA approvals from US FDA in 2018

Indian Pharmaceutical companies and their subsidiaries have established strong presence in US during last couple of years with higher ANDA approvals. The loss of patent exclusivity and cost cutting measures adopted by several nations pushed the demand for generic segment. Indian pharma companies enhanced their investments in research and development (R&D) and successfully received higher approvals from US FDA during last decade. Out of total 5,350 ANDA approvals between 2009 to 2018, Indian companies have secured 34.4% of these approvals and received total 1,842 ANDA final approvals. Further, out of total 1,310 tentative approvals, Indian companies grab 500 tentative approvals from US FDA which worked out to over 38.2%.

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