The manufacturer of the specific Selcaxen 40 mg product is: Everest Pharmaceuticals Ltd.
It would be inappropriate to identify a company as the Selcaxen manufacturer without product-specific evidence.
Development of selpercatinib
Selpercatinib was developed through Loxo Oncology, which became part of Eli Lilly. FDA orphan-drug records identify Loxo Oncology as the sponsor of the selpercatinib development program.
Eli Lilly subsequently became responsible for the commercial development and marketing of RETEVMO. Current U.S. labeling identifies Lilly USA, LLC as the marketer of RETEVMO.
Reference product
The established U.S. reference brand is RETEVMO. It received its initial U.S. approval in 2020.
European authorization
The EMA lists Eli Lilly Nederland B.V. as the marketing authorization holder for Retsevmo in the European Union.
Manufacturer versus developer
These terms should remain distinct:
- Developer: organization involved in developing the medicine.
- Manufacturer: entity responsible for manufacture of a particular product.
- Brand owner: entity associated with a commercial brand.
- Marketing authorization holder: entity responsible for a medicinal-product authorization in a particular jurisdiction.
- Distributor: organization involved in distribution.
- Supplier: party supplying a product through a particular channel.
The documented relationship for RETEVMO does not automatically establish the same relationship for Selcaxen.