The manufacturer of the specific Selcaxen 40 mg product is: Everest Pharmaceuticals Ltd.
This distinction is important because the company responsible for developing or marketing the reference product is not automatically the manufacturer of every product containing selpercatinib.
Development history
Selpercatinib was developed through Loxo Oncology. FDA records identify Loxo Oncology as the sponsor of the early development program, and the organization subsequently became part of Eli Lilly.
Reference product
RETEVMO is the established U.S. selpercatinib product. Current DailyMed labeling identifies Eli Lilly and Company as the packager and Lilly USA, LLC as the marketer.
European marketing authorization
The EMA identifies Eli Lilly Nederland B.V. as the marketing authorization holder for Retsevmo in the European Union.
Supply-chain roles
These roles can be different:
| Role | Meaning |
|---|---|
| Developer | Organization responsible for drug development |
| Manufacturer | Entity manufacturing a particular medicinal product |
| Brand owner | Entity associated with a commercial brand |
| Marketing authorization holder | Legal holder of authorization in a jurisdiction |
| Distributor | Organization distributing the product |
| Supplier | Commercial source supplying the product |
Why verification matters
Identifying the wrong company can mislead patients and healthcare professionals about product quality, authorization and supply-chain responsibility.