Sandoz distinguishes itself through its ability to develop and manufacture generics that are differentiated. Its broad portfolio ranges from advanced application forms -- such as oral solids -- through complex technologies -- such as inhalants and injectables -- and includes transdermal patches.
Sandoz holds one of the most significant product portfolios in Canada with over 250 molecules, including 20 of the 25 most important molecules on the market. Each year, Sandoz Canada expands and diversifies its high-quality, affordable medicines thanks to the in-house development of new products and the acquisition of the right off-patent drugs.
With roots dating back to more than 120 years and as part of the Novartis Group, Sandoz is a trusted leader with a reputation for exceptional quality. Our core business lies in developing, producing, and distributing high-quality medicines following the loss of their respective patent protection, thus helping to give Canadians greater access to affordable, quality healthcare.
While generics may differ with respect to their shape, size or colour, they contain the same active substances as the originator product. They are therapeutically equivalent to, and thus substitutable for, the reference brand product. Given this same active ingredient, full clinical trials are not required in generic development. Rather, we establish the drug’s bioequivalence and demonstrate to regulatory authorities that equivalent dosing has the same effects within the human body as the reference product.
Throughout their development and production processes, generics are required to adhere to the same rigorous standards of quality, safety, and efficacy as originator products. These standards are closely monitored and enforced by the US Food and Drug Administration (FDA) and Health Canada, both before and after product approval. Production facilities are thus regularly inspected to ensure that they are cGMP (current Good Manufacturing Practice) compliant, while marketed products are closely monitored to ensure the highest quality standards.