| Characteristic | ANDA rate of approval |
|---|---|
| - | - |
| - | - |
| - | - |
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Source
Sources
Release date
December 2018
More information
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 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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