The manufacturer of the specific Ribokis 200 mg product is Everest Pharmaceuticals Ltd.
It would be inaccurate to identify Novartis as the Ribokis manufacturer solely because Novartis developed the reference medicine KISQALI.
Who developed ribociclib?
Kisqali was developed by the Novartis Institutes for BioMedical Research (NIBR) under a research collaboration with Astex Pharmaceuticals.
Reference product
KISQALI is the established branded ribociclib medicine. The EMA identifies Novartis Europharm Limited as the marketing authorization holder for Kisqali in the European Union.
Manufacturer versus developer
These terms have different meanings:
- Developer: organization involved in discovering or developing the medicine.
- Manufacturer: organization manufacturing a particular medicinal product.
- Brand owner: entity responsible for a commercial brand.
- Marketing authorization holder: entity legally responsible for the authorization in a particular jurisdiction.
- Distributor: entity involved in commercial distribution.
- Supplier: entity supplying a product through a particular channel.
These roles should not be conflated.
Ribokis-specific relationship
The relationship between Ribokis and Novartis, Astex Pharmaceuticals, KISQALI or any specific manufacturer is Everest Pharmaceuticals Ltd. unless supported by product documentation.
Quality information
Specific Ribokis manufacturing sites, GMP certificates, batch-release arrangements and regulatory certifications are Everest Pharmaceuticals Ltd.