Adalimumab 80mg/0.8mL
| Product Overview | |
| Generic Name | Adalimumab 80mg/0.8mL |
| Brand Name(s) | Humira, Amjevita, Imraldi, Cyltezo, Hyrimoz, Hulio, Hadlima, Abrilada, Cadalimab, Idacio, Simlandi |
| Form | PFS, Vial for subcutaneous injection (solution) |
| Strength | 80 mg/0.8 mL |
| Therapeutic Class | Disease‑modifying antirheumatic drug (DMARD); immunomodulator |
| ATC Code | L04AB04 |
| Manufacturing & Regulatory | |
| Manufacturer | AbbVie (Humira); Biosimilars by Amgen, Samsung Bioepis, Sandoz, Boehringer Ingelheim, Cadila (Cadalimab), Torrent |
| Country | US, India, Canada, Mexico |
| GMP Compliance | WHO‑GMP |
| DMF/CEP | Varies by manufacturer/entity; |
| COFEPRIS | Pending |
| Free Sale Certificate | Yes |
| Logistics & Export | |
| MOQ | 5 units |
| Shelf Life | 24 Months |
| Storage | 2–8 °C; protect from light; do not freeze |
| Incoterms | EXW/FOB/CIF negotiable |
| Lead Time | 7 to 10 Days |
| Documentation | |
| Certificate of Analysis (COA) | Certificate of Analysis is standard from manufacturer; provided per batch |
| SDS | Manufacturer provides standard SDS (biologic/aqueous injectable) |
| CTD Summary | CTD modules are proprietary and require commercial purchase, often with documentation fee. |
Description
Indications & Usage: Adalimumab is a fully human anti‑TNFα monoclonal antibody used for rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis, Crohn’s disease, ulcerative colitis, hidradenitis suppurativa, juvenile idiopathic arthritis, and uveitis. The medication works by binding TNFα, reducing inflammation and immune‑mediated tissue damage.
