Development and Manufacturing Overview
The Apotex Group of Companies is the largest Canadian-owned pharmaceutical company, providing more than 300 generic pharmaceutical products to advance the use of generic medicines in the global healthcare market. Our goals of providing excellence in customer service and the development and manufacture of medicines of the highest quality are accomplished by a highly-skilled workforce using state-of-the-art equipment. Our R&D and production facilities include more than two million square feet throughout the Greater Toronto Area.
A variety of development and production activities are accommodated within a campus of ten buildings situated within a four block radius of our head office at 150 Signet Drive. Activities encompassing our entire range of product development are conducted within the Signet campus. Included are product formulation and process development, the production and evaluation of clinical batches, analytical development and assessment as well as the creation and submission of generic drug approvals.
Production activities on the Signet campus focus on oral solid dose products. A large, modern, multi-product facility, which is located at 150 Signet, is the cornerstone of production and, in conjunction with our packaging facility at 4100 Weston Road, can produce and package in excess of 750 million dosages a month. Process management and data collection is largely computerized to assist this high manufacturing volume. We also have smaller dedicated facilities which focus on penicillin and cephalosporin production as well as the manufacturing of other products requiring additional product or worker protection.
Also found within this Signet campus is our Sales and Marketing team as well as support areas such as Information Services and Human Resources.
The Etobicoke site mirrors the production capabilities of our multi-product facility at 150 Signet and also incorporates the equipment necessary to make the coated pellets that are central to many popular modified-release products. This site, originally established in 1993 to service the US market, went through a large expansion in 2005 to provide capacity to meet future needs. Voted one of the five best new pharmaceutical plants in the world, the expansion included a state-of-the-art material handling facility with a 10,500 pallet, high-bay warehouse capable of totally automated operation and automated guided vehicles to do the heavy lifting.
Research and Development activities for solid dose products are also conducted at the Etobicoke site. An extensive laboratory and pilot plant support the development and data generation for a large number of new submissions every year.
Apotex’s facility in Richmond Hill is devoted to the development and manufacture of sterile and non-sterile liquid products. Key dosage forms include ophthalmic drops, nasal sprays and oral solutions. As with all our facilities, the Richmond Hill plant is regularly inspected and has received approval from Health Canada as well as other significant global regulatory bodies such as the US Food and Drug Administration.
Full R&D capability for liquid dose products is also present at the Richmond Hill facility.
Both aseptically filled and terminally sterilized products are produced within isolator units.