Drug
Who makes tofacitinib?
20 companies list tofacitinib as a human prescription drug, including under the names XELJANZ, XELJANZ XR. Forms: solution; tablet, extended release; tablet, film coated; tablet, film coated, extended release. Routes: oral.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing tofacitinib
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Pfizer Laboratories Div Pfizer Inc | solution; tablet, film coated; tablet, film coated, extended release | NDANDA203214, NDA208246, NDA213082 | 5 | 0 |
| U.S. Pharmaceuticals | solution; tablet, extended release; tablet, film coated | NDANDA203214, NDA208246, NDA213082 | 5 | 0 |
| Zydus Lifesciences LimitedIndia | tablet, film coated; tablet, film coated, extended release | ANDAANDA209829, ANDA214264 | 4 | 12 |
| Zydus Pharmaceuticals USA Inc.India | tablet, film coated; tablet, film coated, extended release | ANDAANDA209829, ANDA214264 | 4 | 1 |
| Apotex Inc.Canada | tablet, film coated; tablet, film coated, extended release | ANDAANDA218096, ANDA220458 | 3 | 6 |
| Aurobindo Pharma LimitedIndia | tablet, extended release; tablet, film coated | ANDAANDA215356, ANDA218462 | 3 | 6 |
| Golden State Medical Supply Inc.United States | tablet, extended release; tablet, film coated | ANDAANDA218096, ANDA218462 | 3 | 1 |
| AvKARE | tablet, film coated; tablet, film coated, extended release | ANDAANDA217299, ANDA220458 | 3 | 0 |
| Novadoz Pharmaceuticals LLC | solution; tablet, film coated | ANDAANDA217298, ANDA217299 | 3 | 0 |
| Macleods Pharmaceuticals LimitedIndia | tablet, film coated | ANDAANDA219530 | 2 | 5 |
| Micro Labs LimitedIndia | tablet, film coated | ANDAANDA209738 | 2 | 5 |
| Somerset Therapeutics Private LimitedIndia | tablet, film coated | ANDAANDA220137 | 2 | 1 |
| Sun Pharmaceutical Industries LimitedIndia | solution | ANDAANDA218407 | 1 | 13 |
| Biocon Biologics LimitedIndia | tablet, film coated, extended release | ANDAANDA219442 | 1 | 9 |
| Hikma Pharmaceuticals USA Inc.United States | solution | ANDAANDA216878 | 1 | 4 |
| Ajanta Pharma LimitedIndia | tablet, extended release | ANDAANDA219542 | 1 | 2 |
| Edenbridge Pharmaceuticals LLC. | tablet, film coated, extended release | ANDAANDA218668 | 1 | 0 |
| Exelan Pharmaceuticals, Inc. | tablet, film coated, extended release | ANDAANDA219830 | 1 | 0 |
| IPG Pharmaceuticals, Inc. | solution | ANDAANDA219370 | 1 | 0 |
| Orient Pharma Co., Ltd. Yunlin Plant | tablet, film coated, extended release | ANDAANDA219830 | 1 | 0 |
Bulk ingredient listings
- Dr. Reddy's Laboratories LimitedIndia · 1 NDC
Enquiry
Common questions
- Who makes tofacitinib?
- 20 companies list tofacitinib as a human prescription drug in the openFDA NDC Directory, led by Pfizer Laboratories Div Pfizer Inc, U.S. Pharmaceuticals, Zydus Lifesciences Limited, Zydus Pharmaceuticals USA Inc., Apotex Inc.. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic XELJANZ?
- 18 companies list tofacitinib under an abbreviated new drug application (ANDA), the application type used for generics, and 2 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies tofacitinib active ingredient?
- 1 company lists tofacitinib as a bulk ingredient, including Dr. Reddy's Laboratories Limited.