Apotex and its Affiliates have expertise in formulation, analytical and clinical development of complex generics.

Examples include:

  • HepaGam BTM (Hepatitis B Immune Globulin – human)
  • Fluticasone Propionate Nasal Spray
  • Calcitonin Nasal Spray

Apotex has considerable in-house expertise in clinical development and regulatory affairs including its own bioclinical development department which is responsible for Phase I-III studies including in-house bioequivalence studies.

We have substantial R&D, clinical development and regulatory affairs teams based in Toronto, Canada which are supported by additional members in India and local regulatory affairs members in each of our marketing operations.

Apotex is interested in collaborating in co-development of any generic opportunity whether it is for pharmaceuticals or biologicals that require clinical development beyond typical bioequivalence studies.