Try our corporate solution for free!
+1 (212) 419-5770

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

Exclusive Premium statistic

You need a Single Account for unlimited access.

  • Full access to 1m statistics

  • Incl. source references

  • Available to download in PNG, PDF, XLS format

Single Account

$39 $59 per month *
in the first 12 months
33% Discount until October 31st
*Duration: 12 months, billed annually, single license

Access to this and all other statistics on 80,000 topics from

$468 / Year
$708 / Year

Show detailed source information?
Register for free
Already a member?
Log in

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 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.

Statista Accounts: Access All Statistics. Starting from $468 / Year
Basic Account
Get to know the platform

You only have access to basic statistics.
This statistic is not included in your account.

Single Account
The ideal entry-level account for individual users
  • Instant access to 1m statistics
  • Download in XLS, PDF & PNG format
  • Detailed references
$59 $39 / Month *
in the first 12 months
Corporate Account
Full access

Corporate solution including all features.

* All products require an annual contract; Prices do not include sales tax.

Statistics on "Pharmaceutical industry in India"

Statista Accounts: Access All Statistics. Starting from $468 / Year
Learn more about how Statista can support your business.