CALQUENCE® (acalabrutinib) 100mg
| Product Overview | |
| Generic Name | CALQUENCE® (acalabrutinib) 100mg |
| Brand Name(s) | Calquence® |
| Product Type | Originator Brand |
| Form | 56 Oral Capsules |
| Strength | 100 mg oral capsules |
| Therapeutic Class | Bruton’s tyrosine kinase inhibitor — BTK inhibitor. |
| ATC Code | L01EL02 |
| Manufacturing & Regulatory | |
| Manufacturer | AstraZeneca |
| Country | Sweden |
| GMP Compliance | FDA/EMA/WHO-GMP |
| COFEPRIS | 010.000.6327.00 |
| Free Sale Certificate | Available from manufacturer/exporter upon request |
| Logistics & Export | |
| MOQ | 5 units |
| Shelf Life | 24 Months |
| Storage | Store at 20–25 °C |
| Incoterms | EXW, HSN 300490 |
| Lead Time | 7 - 10 Business Days |
| Documentation | |
| Certificate of Analysis (COA) | Manufacturer provides COA per batch |
| CTD Summary | Public FDA/EMA label/SmPC available; full CTD is not public |
Description
Acalabrutinib is an oral BTK inhibitor used in adults with chronic lymphocytic leukemia / small lymphocytic lymphoma and mantle cell lymphoma, including combination regimens such as acalabrutinib plus venetoclax for CLL/SLL and acalabrutinib plus bendamustine/rituximab for certain MCL settings.
