Rate of approval for Indian pharma ANDA by U.S. FDA 2017-2019

There was a 67.9 percent approval rate for new drug applications made by the top five Indian pharma companies to the U.S. Food and Drug Administration (USFDA) in the first half of 2019. This was an increase compared to the previous year's first half approval rate of 65.5 percent.

Rate of approval for Indian ANDAs by the U.S. FDA from the first half of 2017 to first half of 2019

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Release date

December 2018


India, United States

Survey time period

H1 2017 to H1 2019

Supplementary notes

ANDA refers to Abbreviated New Drug Application (ANDA). An ANDA approval from U.S. Food and Drug Administration is required to market a generic drug in USA.
Note: The sample includes data of top 5 Indian pharma companies and the approvals exclude tentative approvals.
Data represents only the first half of the fiscal year for all three years. India's fiscal year starts in April and ends in March. For example, FY 2018 started in April 2017 and ended in March 2018.

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Statistics on "Pharmaceutical industry in India"

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