Tofacitinib 5mg
| Product Overview | |
| Generic Name | Tofacitinib 5mg |
| Brand Name(s) | Xeljanz®, Tofajak/JakNat |
| Product Type | Generic |
| Form | 60 Immediate-release film-coated tablets |
| Strength | 5mg |
| Therapeutic Class | Targeted synthetic DMARD; JAK inhibitor |
| ATC Code | L04AF01 |
| Manufacturing & Regulatory | |
| Manufacturer | Pfizer, Ajanta, Cipla, Natco |
| Country | Ireland, USA, Canada, India |
| GMP Compliance | WHO-GMP |
| COFEPRIS | 010.000.6111.01 |
| Free Sale Certificate | Yes, available as COPP/CPP |
| 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) | Supplied per batch upon request |
| CTD Summary | Originator/generic CTD is not public; available only under regulatory/supplier NDA. |
Description
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.
