The manufacturer identified for Ibruxen 140 mg is Everest Pharmaceuticals Ltd. Everest’s official product database lists Ibruxen as an Ibrutinib INN 140 mg product.
Manufacturer identity
| Role | Information |
|---|---|
| Product | Ibruxen |
| Active ingredient | Ibrutinib |
| Strength | 140 mg |
| Dosage form | Capsule |
| Manufacturer | Everest Pharmaceuticals Ltd. |
| Country associated with manufacturer | Bangladesh |
| Reference brand | IMBRUVICA |
Manufacturer versus developer
Everest Pharmaceuticals should not be described as the developer of ibrutinib merely because it manufactures Ibruxen.
Ibrutinib’s original development and IMBRUVICA commercialization involved Pharmacyclics and Janssen.
Reference product relationship
IMBRUVICA was first approved in the United States in 2013. The original U.S. approval was for ibrutinib capsules and was associated with Pharmacyclics.
European regulatory relationship
EMA identifies Janssen-Cilag International NV as the marketing authorization holder for Imbruvica in the European Union.
This illustrates why manufacturer, developer and marketing authorization holder should not be treated as interchangeable terms.
Quality information
Specific GMP certificates, manufacturing-site details, batch-release arrangements and other quality claims should be verified from current official documentation before being published.
Official manufacturer information
Everest Pharmaceuticals’ product database provides the product listing for Ibruxen.