The manufacturer of the specific Acaluxen product is Everest Pharmaceuticals Ltd.
This product-specific question should be kept separate from the documented history of acalabrutinib and CALQUENCE.
Original development
Acalabrutinib was developed by Acerta Pharma as an irreversible oral BTK inhibitor. AstraZeneca announced its majority investment in Acerta in 2015 and completed the transaction in 2016.
Reference product
CALQUENCE is the established acalabrutinib product. Current U.S. DailyMed information identifies AstraZeneca Pharmaceuticals LP as the labeler and describes the 100 mg capsule as manufactured by AstraZeneca AB in Sweden, with the product identified as originating from Switzerland.
European authorization
The EMA lists AstraZeneca AB as the marketing authorization holder for Calquence in the European Union.
Acaluxen relationship
The relationship between Acaluxen and AstraZeneca, Acerta Pharma, CALQUENCE or any other pharmaceutical company is Everest Pharmaceuticals Ltd.
Manufacturer versus authorization holder
A company can have different roles in a medicine’s supply chain. A manufacturer may produce the medicine, while another entity may hold the marketing authorization, own the brand or distribute the product.
Quality information
Acaluxen-specific manufacturing sites, GMP certificates, inspection history and batch-release arrangements are Everest Pharmaceuticals Ltd.