The manufacturer of the specific Ponaxen product is Everest Pharmaceuticals Ltd.
This should not be confused with the documented history of ponatinib and ICLUSIG.
Original developer
The original U.S. Iclusig development program was submitted by ARIAD Pharmaceuticals, Inc. FDA records identify ARIAD as the applicant for NDA 203469 and describe ponatinib as an orally available tyrosine kinase inhibitor.
Current U.S. ICLUSIG product
The current DailyMed record identifies Takeda Pharmaceuticals America, Inc. as the packager of the listed ICLUSIG product. This does not establish that Takeda manufactures or markets every ponatinib product worldwide.
European authorization
The current EMA EPAR identifies Incyte Biosciences Distribution B.V. as the marketing authorization holder for Iclusig in the EU.
Different roles
These terms have different meanings:
- Originator/developer: company responsible for development of the original medicine.
- Manufacturer: entity responsible for manufacture of a specific product.
- Brand owner: entity associated with a commercial brand.
- Marketing authorization holder: entity legally responsible for the authorization in a jurisdiction.
- Distributor: entity involved in commercial distribution.
- Supplier: entity supplying a product through a particular channel.