Apotex Inc.
Apotex is a global pharmaceutical company committed to improving health through innovation, manufacturing excellence, and social responsibility. With a presence in multiple countries, Apotex focuses on providing high-quality medicines and advancing health access worldwide. The company emphasizes sustainability, responsible business practices, and community support, including grants and donations to health-related causes.
Industries
Nr. of Employees
Very Large (1000+)
Products
Generic nilotinib capsules (kinase inhibitor) — first-to-market generic with 180 days exclusivity
Generic oral kinase-inhibitor formulation indicated for treatment of certain leukemias; launched as a first-to-market generic receiving 180 days of market exclusivity.
Ready-to-dilute melphalan hydrochloride injection (multidose vial) — approved via 505(b)(2)
A ready-to-dilute liquid formulation of a chemotherapeutic agent in multidose vials approved through a 505(b)(2) regulatory pathway.
Aflibercept biosimilar (vial and pre-filled syringe formats)
A biosimilar monoclonal/protein therapeutic supplied in vial and pre-filled syringe presentations for ophthalmic and retinal indications.
Generic nilotinib capsules (kinase inhibitor) — first-to-market generic with 180 days exclusivity
Generic oral kinase-inhibitor formulation indicated for treatment of certain leukemias; launched as a first-to-market generic receiving 180 days of market exclusivity.
Ready-to-dilute melphalan hydrochloride injection (multidose vial) — approved via 505(b)(2)
A ready-to-dilute liquid formulation of a chemotherapeutic agent in multidose vials approved through a 505(b)(2) regulatory pathway.
Aflibercept biosimilar (vial and pre-filled syringe formats)
A biosimilar monoclonal/protein therapeutic supplied in vial and pre-filled syringe presentations for ophthalmic and retinal indications.
Services
End-to-end manufacturing of oral solid doses and sterile injectables at multiple global sites for commercial supply.
Development of formulations (oral and parenteral), analytical support and preparation of regulatory submissions including 505(b)(2) and biosimilar dossiers.
Storage, packaging and regional distribution services across North America, Mexico and Asia to support continuous supply of finished products.
Provision of donated medicines and financial grants through a global health access fund in partnership with international health organizations to support underserved populations.
End-to-end manufacturing of oral solid doses and sterile injectables at multiple global sites for commercial supply.
Development of formulations (oral and parenteral), analytical support and preparation of regulatory submissions including 505(b)(2) and biosimilar dossiers.
Storage, packaging and regional distribution services across North America, Mexico and Asia to support continuous supply of finished products.
Provision of donated medicines and financial grants through a global health access fund in partnership with international health organizations to support underserved populations.
Expertise Areas
- Large-scale pharmaceutical manufacturing
- API production
- Sterile injectable development and manufacturing
- Generics and biosimilars development
Key Technologies
- Solid oral dosage manufacturing
- Sterile parenteral formulation and filling
- Active pharmaceutical ingredient (API) manufacturing
- GMP quality systems
News & Updates
Nilotinib is a kinase inhibitor indicated to treat certain types of leukemia, including newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia in the US.
The report underscores Apotex's commitment to sustainability, transparency, and long-term value creation.
Apotex launched IVRA, the first ready-to-dilute liquid formulation of Melphalan injection approved via 505(b)(2) NDA in the US.
Nilotinib is a kinase inhibitor indicated to treat certain types of leukemia, including newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia in the US.
The report underscores Apotex's commitment to sustainability, transparency, and long-term value creation.
Apotex launched IVRA, the first ready-to-dilute liquid formulation of Melphalan injection approved via 505(b)(2) NDA in the US.