Healthcare ranking
Top 25 drug companies by FDA approvals 2026
Aurobindo Pharma received the most original FDA drug approvals between 1 November 2025 and 31 October 2026, with 41 approvals. The list ranks companies by the number of new and generic drug applications approved for the first time in that period.
Top 10 at a glance
The full list
| Rank | Company | Headquarters | FDA original drug approvals (new and generic) (approvals) |
|---|---|---|---|
| 1 | Aurobindo Pharma | India | 41 |
| 2 | Zydus Lifesciences | India | 32 |
| 3 | MSN Laboratories | India | 30 |
| 4 | Teva Pharmaceuticals | Israel | 28 |
| 5 | Micro Labs | India | 26 |
| 6 | Apotex | Canada | 24 |
| 7 | Alembic Pharmaceuticals | India | 22 |
| 8 | Amneal Pharmaceuticals | United States | 20 |
| 9 | Macleods Pharmaceuticals | India | 19 |
| 10 | Dr. Reddy's Laboratories | India | 17 |
| 11 | Hetero Labs | India | 16 |
| 12 | ANI Pharmaceuticals (Novitium) | United States | 14 |
| 12 | Lupin | India | 14 |
| 12 | Sandoz | Switzerland | 14 |
| 15 | Cipla | India | 13 |
| 16 | Gland Pharma | India | 12 |
| 16 | Sun Pharma | India | 12 |
| 18 | Baxter | United States | 11 |
| 18 | Viatris | United States | 11 |
| 20 | PharmaZone | 10 | |
| 21 | Biocon | India | 9 |
| 21 | Caplin Steriles | India | 9 |
| 21 | Hikma Pharmaceuticals | United Kingdom | 9 |
| 21 | Rubicon Research | India | 9 |
| 25 | Mankind Pharma | India | 8 |
| 25 | Somerset Therapeutics | United States | 8 |
How this list is built
We counted new drug, generic drug and biologic applications 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. New drug applications include new forms of existing medicines, so this is not a count of novel drugs.
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 drug companies by FDA approvals ranking?
Aurobindo Pharma ranks first with 41 approvals (1 November 2025 to 31 October 2026).
How is this ranking calculated?
We counted new drug, generic drug and biologic applications 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. New drug applications include new forms of existing medicines, so this is not a count of novel drugs.
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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