Xeljanz® (tofacitinib) 5mg
| Product Overview | |
| Generic Name | Xeljanz® (tofacitinib) 5mg |
| Brand Name(s) | Xeljanz®, Xeljanz XR® Tofajak/JakNat |
| Product Type | Originator Brand |
| Form | 60 Immediate-release film-coated tablets |
| Strength | 5mg |
| Therapeutic Class | Targeted synthetic DMARD; JAK inhibitor |
| ATC Code | L04AF01 |
| Manufacturing & Regulatory | |
| Manufacturer | Pfizer |
| Country | Ireland, USA, Canada |
| GMP Compliance | WHO-GMP |
| COFEPRIS | 010.000.6111.01 |
| Free Sale Certificate | may obtain export certificate from regulatory authority |
| Logistics & Export | |
| MOQ | 5 units |
| Shelf Life | 24 Months |
| Storage | Store at 20–25 °C |
| Incoterms | EXW, HSN 30049099 |
| Lead Time | 7 - 10 Business Days |
| Documentation | |
| Certificate of Analysis (COA) | Manufacturer provides COA |
| CTD Summary | Originator/generic CTD is not public; available only under regulatory/supplier NDA. |
Description
Xeljanz® (tofacitinib) is an oral JAK inhibitor used for immune-mediated inflammatory diseases. Approved indications include moderate-to-severe rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, and polyarticular juvenile idiopathic arthritis, generally after inadequate response or intolerance to prior therapies such as TNF blockers or DMARDs. It carries major safety warnings for serious infections, malignancy, MACE, thrombosis, and mortality.
