Available pharmaceutical product information identifies Glenmark Pharmaceuticals Ltd. as the manufacturer/marketer of Abirapro 250 mg.
Glenmark’s role
For the Abirapro product, Glenmark is identified in available product listings as the manufacturer/marketer.
The precise manufacturing site, marketing authorization holder and distributor can differ by jurisdiction and are [Information requires verification] unless supported by current regulatory records.
Original development of abiraterone
The history of abiraterone is separate from the Abirapro manufacturing relationship.
The compound was developed from research at the Institute of Cancer Research. Rights were subsequently licensed to BTG and then to Cougar Biotechnology, which developed the commercial medicine. Cougar was acquired by Johnson & Johnson.
Reference product
Zytiga is the major reference product containing abiraterone acetate. FDA records for the original U.S. application identify Centocor Ortho Biotech, a unit of Cougar Biotechnology and Johnson & Johnson subsidiary, as the applicant.
Manufacturer is not the same as originator
The following roles should be kept distinct:
| Role | Meaning |
| Original developer | Developed the medicine scientifically |
| Reference-product company | Responsible for the reference medicine |
| Manufacturer | Manufactures a specific product |
| Brand owner | Owns a commercial brand |
| Marketing authorization holder | Holds authorization in a jurisdiction |
| Distributor | Distributes the product |
| Supplier | Supplies through a commercial channel |
Quality information
Specific Abirapro manufacturing-site certifications and current GMP documentation are [Information requires verification].