The specific manufacturer of Lorbrexen 100 mg is Everest Pharmaceuticals Ltd.
This distinction is important because the company that developed lorlatinib is not automatically the manufacturer of every product containing lorlatinib.
Who developed lorlatinib?
Pfizer states that lorlatinib was discovered by Pfizer scientists and developed as a next-generation ALK inhibitor. Pfizer specifically describes the development program as being designed to address resistance to earlier ALK inhibitors and penetrate the blood-brain barrier.
Reference brands
In the United States, lorlatinib is marketed as LORBRENA. In the European Union, the brand is Lorviqua.
European authorization holder
The EMA identifies Pfizer Europe MA EEIG as the marketing authorization holder for Lorviqua.
This should not be interpreted as evidence that Pfizer manufactures the separate Lorbrexen product.
Manufacturer versus developer
These roles have different meanings:
- Developer/originator: the organization that discovered and developed the medicine.
- Manufacturer: the entity responsible for manufacturing a particular medicinal product.
- Brand owner: the entity associated with a commercial brand.
- Marketing authorization holder: the entity legally responsible for a product authorization in a jurisdiction.
- Distributor: a party involved in product distribution.
- Supplier: a party supplying the medicine through a commercial channel.
For Lorbrexen, these relationships are Everest Pharmaceuticals Ltd.
Quality information
Specific claims about Lorbrexen manufacturing facilities, GMP certification, batch-release arrangements or regulatory inspections should not be published without documentary evidence.