Data / Drug companies / Sirolimus
Sirolimus: 22 companies and 40 products in the FDA NDC directory
Sirolimus is listed in the FDA National Drug Code Directory by 22 companies, with 40 products in commercial distribution. 34 of the products (85.0%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are tablet, film coated; solution; tablet, and the newest product started marketing on October 27, 2026.
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- Companies listing it
- 22
- Products
- 40
- Generic (ANDA) products
- 34 (85.0%)
- Application numbers
- 14
- Routes
- Oral, Topical, Intravenous
- Brand names
- Hyftor, Fyarro
- openFDA record search
- api.fda.gov
Companies that list sirolimus
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Mylan Pharmaceuticals Inc. | 4 | tablet, sugar coated; solution | Authorized generics (NDA) | July 22, 2019 |
| Remedyrepack Inc. | 4 | tablet; tablet, film coated | Generic drugs (ANDA) | August 19, 2025 |
| Ascend Laboratories, LLC | 3 | tablet, film coated | Generic drugs (ANDA) | March 13, 2021 |
| Glenmark Pharmaceuticals Inc., USA | 3 | tablet, film coated | Generic drugs (ANDA) | October 16, 2020 |
| NorthStar Rx LLC | 3 | tablet, film coated | Generic drugs (ANDA) | October 18, 2021 |
| Zydus Lifesciences Limited | 3 | tablet, film coated | Generic drugs (ANDA) | February 16, 2023 |
| Zydus Pharmaceuticals USA Inc. | 3 | tablet, film coated | Generic drugs (ANDA) | February 16, 2023 |
| AvPAK | 2 | tablet; tablet, film coated | Generic drugs (ANDA) | October 27, 2026 |
| Dr. Reddy's Laboratories Limited | 2 | tablet | Generic drugs (ANDA) | October 27, 2014 |
| Aadi Bioscience, Inc. | 1 | injection, powder, lyophilized, for suspension | New drug applications (NDA) | December 6, 2021 |
| American Health Packaging | 1 | tablet | Generic drugs (ANDA) | November 5, 2015 |
| American Health Packaging | 1 | tablet, film coated | Generic drugs (ANDA) | June 2, 2026 |
| Amneal Pharmaceuticals NY LLC | 1 | solution | Generic drugs (ANDA) | October 25, 2019 |
| Apotex Corp. | 1 | solution | Generic drugs (ANDA) | May 20, 2020 |
| Bryant Ranch Prepack | 1 | solution | Generic drugs (ANDA) | January 19, 2023 |
| Camber Pharmaceuticals, Inc. | 1 | solution | Generic drugs (ANDA) | September 16, 2024 |
| Major Pharmaceuticals | 1 | tablet, film coated | Generic drugs (ANDA) | March 13, 2021 |
| Nobelpharma America, LLC | 1 | gel | New drug applications (NDA) | March 23, 2022 |
| NorthStar RxLLC | 1 | solution | Generic drugs (ANDA) | January 19, 2023 |
| Novadoz Pharmaceuticals LLC | 1 | solution | Generic drugs (ANDA) | January 19, 2023 |
| Rising Pharma Holdings, Inc. | 1 | solution | Generic drugs (ANDA) | July 15, 2025 |
| VistaPharm, LLC | 1 | solution | Generic drugs (ANDA) | January 28, 2019 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Tablet, film coated | 20 | 50% |
| Solution | 9 | 22.5% |
| Tablet | 6 | 15% |
| Tablet, sugar coated | 3 | 7.5% |
| Gel | 1 | 2.5% |
| Injection, powder, lyophilized, for suspension | 1 | 2.5% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 34 | 85% |
| Authorized generics (NDA) | 4 | 10% |
| New drug applications (NDA) | 2 | 5% |
Pharmacologic classes
| Class | Products |
|---|---|
| Kinase Inhibitor | 40 |
| mTOR Inhibitor Immunosuppressant | 40 |
Updated November 6, 2026. Read from US Food and Drug Administration, National Drug Code Directory (openFDA). CC0 1.0 public domain dedication (openFDA). Counts are products in the FDA National Drug Code Directory on November 6, 2026: 138,262 products in commercial distribution, meaning without a marketing end date in the past. A company is a labeler code; one company can hold several codes, and the directory carries no address. Inclusion in the directory is not FDA approval, and the marketing category says under which kind of application or rule a product is sold. This page uses openFDA data and is not endorsed or certified by FDA. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.