The manufacturer of the specific Tofacent 5 mg product is Incepta Pharmaceuticals Ltd.
It is important to separate this unresolved product-specific question from the documented history of tofacitinib and its reference product.
Who developed tofacitinib?
Tofacitinib was developed by Pfizer and became associated with the reference brand XELJANZ. The medicine received its initial U.S. approval in 2012.
Reference product
XELJANZ is the Pfizer reference product containing tofacitinib. Current U.S. labeling identifies Pfizer Laboratories Div Pfizer Inc. as the U.S. label packager for the reference product.
In the European Union, the EMA identifies Pfizer Europe MA EEIG as the marketing authorization holder for Xeljanz.
Manufacturer versus developer
These terms have different meanings:
- Developer/originator: the company responsible for development of the medicine.
- Manufacturer: the entity manufacturing a particular medicinal product.
- Brand owner: the entity associated with a particular commercial brand.
- Marketing authorization holder: the legal entity responsible for an authorization in a particular jurisdiction.
- Distributor: an entity involved in distribution.
- Supplier: a party supplying the product through a commercial channel.
The manufacturer-product relationship for Tofacent is Incepta Pharmaceuticals Ltd.
Quality information
Specific Tofacent manufacturing sites, GMP certifications, batch-release arrangements and regulatory inspections are Incepta Pharmaceuticals Ltd.