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Number of Indian ANDA approvals by the U.S. FDA 2017-2019

During the first half of 2019, over 2,000 new drug applications were made to the U.S. Food and Drug Administration by India's top five pharma companies. From the total applications, 1,374 applications were approved. Overall, India had some of the highest approval ratings from the U.S. FDA in terms of new drug applications.

Number of Indian ANDAs approved by the U.S. FDA from first half of 2017 to first half of 2019

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Sources

Release date

December 2018

Region

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 five 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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