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Healthcare ranking

Top 10 companies by FDA oral liquid drug approvals 2026

ANI Pharmaceuticals (Novitium) received the most FDA approvals of oral liquid drugs between 1 November 2025 and 31 October 2026, with 8 approvals. The list ranks companies by the number of drug applications for oral solutions and suspensions approved for the first time in that period.

  • MeasureFDA original approvals of oral liquid drugs
  • Period1 November 2025 to 31 October 2026
  • Ranked13 companies
  • Updated10 Nov 2026

Top 10 at a glance

  1. ANI Pharmaceuticals (Novitium)8 approvals
  2. Aurobindo Pharma6 approvals
  3. Hetero Labs5 approvals
  4. Rubicon Research5 approvals
  5. Adaptis4 approvals
  6. Quagen Pharmaceuticals4 approvals
  7. MSN Laboratories3 approvals
  8. Sun Pharma3 approvals
  9. Alembic Pharmaceuticals2 approvals
  10. Alkem Laboratories2 approvals

The full list

RankCompanyHeadquartersFDA original approvals of oral liquid drugs (approvals)
1ANI Pharmaceuticals (Novitium)United States8
2Aurobindo PharmaIndia6
3Hetero LabsIndia5
3Rubicon ResearchIndia5
5Adaptis4
5Quagen PharmaceuticalsUnited States4
7MSN LaboratoriesIndia3
7Sun PharmaIndia3
9Alembic PharmaceuticalsIndia2
9Alkem LaboratoriesIndia2
9LupinIndia2
9Micro LabsIndia2
9Regcon Holdings2

How this list is built

We counted drug applications that include an oral solution, suspension or syrup 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 ("ANNORA PHARMA" and "HETERO LABS LTD III" are counted as Hetero Labs). 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 companies by FDA oral liquid drug approvals ranking?

ANI Pharmaceuticals (Novitium) ranks first with 8 approvals (1 November 2025 to 31 October 2026).

How is this ranking calculated?

We counted drug applications that include an oral solution, suspension or syrup 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 ("ANNORA PHARMA" and "HETERO LABS LTD III" are counted as Hetero Labs). 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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