The manufacturer of the specific Palbocent 125 mg product is: Incepta Pharmaceuticals Ltd.
It would be misleading to identify Pfizer as the Palbocent manufacturer without product-specific evidence.
Pfizer and palbociclib
Pfizer developed IBRANCE (palbociclib) and announced its first U.S. FDA approval in February 2015. Pfizer’s historical product information describes IBRANCE as discovered and marketed by Pfizer.
Reference product
IBRANCE is the reference product associated with palbociclib in the European Union. The EMA identifies Pfizer Europe MA EEIG as the marketing authorization holder for Ibrance in the EU.
Manufacturer versus developer
These terms describe different roles:
- Developer: organization that developed the medicine.
- Reference-product company: organization associated with the reference medicine.
- Manufacturer: entity manufacturing a particular product.
- Brand owner: entity controlling a specific commercial brand.
- Marketing authorization holder: legal entity responsible for the authorization in a jurisdiction.
- Distributor: organization involved in distribution.
- Supplier: entity supplying a product through a particular commercial channel.
These roles may be held by different companies.
Palbocent-specific relationship
The following information requires verification:
| Relationship | Palbocent status |
|---|---|
| Specific manufacturer | Incepta Pharmaceuticals Ltd. |
| Brand owner | Incepta Pharmaceuticals Ltd. |
| Marketing authorization holder | Incepta Pharmaceuticals Ltd. |
| Distributor | Incepta Pharmaceuticals Ltd. |
| Supplier | Incepta Pharmaceuticals Ltd. |
| Relationship to Pfizer | Incepta Pharmaceuticals Ltd. |