Healthcare ranking
Top 25 generic drug companies by FDA approvals 2026
Aurobindo Pharma received the most FDA generic drug approvals between 1 November 2025 and 31 October 2026, with 40 approvals. The list ranks companies by the number of abbreviated new drug applications (generics) approved for the first time in that period.
Top 10 at a glance
The full list
| Rank | Company | Headquarters | FDA generic drug (ANDA) approvals (approvals) |
|---|---|---|---|
| 1 | Aurobindo Pharma | India | 40 |
| 2 | Zydus Lifesciences | India | 32 |
| 3 | MSN Laboratories | India | 30 |
| 4 | Micro Labs | India | 26 |
| 5 | Teva Pharmaceuticals | Israel | 25 |
| 6 | Apotex | Canada | 23 |
| 7 | Alembic Pharmaceuticals | India | 22 |
| 8 | Macleods Pharmaceuticals | India | 19 |
| 9 | Amneal Pharmaceuticals | United States | 17 |
| 10 | Dr. Reddy's Laboratories | India | 16 |
| 10 | Hetero Labs | India | 16 |
| 12 | ANI Pharmaceuticals (Novitium) | United States | 14 |
| 13 | Cipla | India | 13 |
| 13 | Sandoz | Switzerland | 13 |
| 15 | Gland Pharma | India | 12 |
| 15 | Lupin | India | 12 |
| 17 | Sun Pharma | India | 11 |
| 18 | PharmaZone | 10 | |
| 18 | Viatris | United States | 10 |
| 20 | Baxter | United States | 9 |
| 20 | Biocon | India | 9 |
| 20 | Caplin Steriles | India | 9 |
| 20 | Hikma Pharmaceuticals | United Kingdom | 9 |
| 20 | Rubicon Research | India | 9 |
| 25 | Mankind Pharma | India | 8 |
| 25 | Somerset Therapeutics | United States | 8 |
How this list is built
We counted abbreviated new drug applications (generics) whose original submission was approved between 1 November 2025 and 31 October 2026; supplements and tentative approvals are not counted, and each application counts once whatever its number of strengths. Applications filed under subsidiaries and name variants are merged into the parent company ("AUROBINDO PHARMA LTD" and "EUGIA PHARMA" are counted as Aurobindo Pharma). Companies with the same count share a rank, and all companies tied at the last place are shown.
Every position is set by the data alone, by the same rules for every company. Spotted something to update? Write to info@stratummarketresearch.com with the list and the line, and we correct it within two working days.
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Frequently asked questions
Who is number one in the generic drug companies by FDA approvals ranking?
Aurobindo Pharma ranks first with 40 approvals (1 November 2025 to 31 October 2026).
How is this ranking calculated?
We counted abbreviated new drug applications (generics) whose original submission was approved between 1 November 2025 and 31 October 2026; supplements and tentative approvals are not counted, and each application counts once whatever its number of strengths. Applications filed under subsidiaries and name variants are merged into the parent company ("AUROBINDO PHARMA LTD" and "EUGIA PHARMA" are counted as Aurobindo Pharma). Companies with the same count share a rank, and all companies tied at the last place are shown.
Can a company pay to rank higher?
Positions come only from the counts described above, and inclusion is free. Every company is ranked by the same rules.
How often is the ranking updated?
Every list is recomputed each quarter from the latest public records, and the update date is printed on the page.
Can a ranked company use the badge?
Yes. Every ranked company can use the free web badge on this page on its website, in press releases and on social media.
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