Research & Development

Product Development - Solid Dose
Product Development - Solid Dose has 400 employees in these six main areas: Formulation Development, Analytical Operations (Analytical Development, Active Pharmaceutical Ingredients Evaluation, Chemistry and Compendia, and Specifications and Technology Transfer), Technical Operations, Product Evaluation, Laboratory Technical Services, and Laboratory Information Management System. Product Development - Solid Dose activities take place at our Signet and Etobicoke sites in Canada, and at our facilities in India.

Product Development - Liquid Dose
The Product Development - Liquid Dose facilities are located in Richmond Hill and employ 130 highly skilled individuals in the following four departments: Analytical Operations (Analytical Development, Product Evaluation and Technical Documentation), Formulation Development, Process and Packaging Development, and Technical Operations.

Regulatory and Medical Affairs
Regulatory and Medical Affairs is made up of several different functions. These are Regulatory Affairs (Canadian, US, International and Liquid Dose), Pharmacovigilance (Drug Safety and Library & Information Services), Research and Development (R&D) Compliance, and 3rd Party In-Licensing. There are 200 people involved in Regulatory and Medical Affairs activities, which occur in Canada, Europe, Australia, New Zealand, and other International Affiliates.

Bioclinical Development (BCD)
This group is responsible for all clinical (human) trials in support of the generic products. This includes both Bioequivalence and Clinical Equivalence trials. BCD employs 200 people and is located at our Signet Campus in Canada, and facilities in India. BCD is comprised of Clinical Operations, Bioanalytical Laboratory, Pharmacokinetics, Clinical Development Unit, and CRO Client Services. They perform various types of work from protocol development to completion of the Clinical trial reports for submission.

Apotex India
Apotex has set up state-of-the art R&D and Manufacturing facilities in India for Active Pharmaceutical Ingredients (API’s), Solid Dose Formulations and BioClinical Development. These facilities are located at the Bommasandra Industrial Area located in outskirts of the city of Bangalore.

ApoPharma Inc.
ApoPharma Inc. was launched in January 2004, and evolved out of the former Innovative Drug Division (IDD) of Apotex Inc. ApoPharma belongs to the Apotex Group of companies, one of the largest and most successful companies in the world in the development of low cost alternative medications-generic drugs. The function of ApoPharma is to discover and develop new chemical entities and innovative pharmaceutical products for international markets. The company’s expertise is focused mainly in the areas of iron chelation and immunomodulation.

The first product to get licensed, Ferriprox™ (deferiprone), was approved by the European Commission in August 1999. Ferriprox is an iron chelator that reduces the risk of iron-induced toxicity in patients with iron overload and, as of June 2008, was approved in 58 countries around the world. The increasingly recognized importance of iron in the pathology of several diseases has led ApoPharma to invest in the development of a series of novel molecules designed to remove iron from different iron pools in the body, or prevent iron-mediated pathology. One aspect of our pipeline is focused on new iron chelators both for those diseases that are caused by iron overload as well as for conditions where iron plays a critical role in pathology, but in the absence of generalized iron overload. The other stream in our pipeline relates to novel dipeptides that exert immunomodulatory activity, with our first indication being psoriasis.

ApoPharma has about 100 dedicated staff, including its own discovery and development groups, medical, clinical, non-clinical, data management, sales and marketing, regulatory and quality assurance groups. ApoPharma has the advantage that it draws upon resources within the Apotex Group of companies for supportive R&D activities, such as analytical chemistry and formulation development, and all of the service groups, including human resources, information technology, etc., enabling it to attain maximum leverage of the Apotex size and expertise. It is further supported by close collaboration with scientists in academic institutions around the world giving ApoPharma access to the scientific expertise that comes with a large critical mass.