Quality Standards

For Sandoz, quality is far more than an external requirement. We are committed to providing healthcare products and services of a consistently high standard, worldwide. We believe that consistent and reliable quality is what helps to set us apart from our competition, by offering customers the safety and efficacy associated with reference medicines, at lower cost.

At Sandoz, we believe quality and compliance are about more than just systems, methodologies and processes. Superior levels of quality and compliance also depend on our own commitment, self-discipline, excellence and desire for improvement. This philosophy is what makes Sandoz special.

External regulatory standards

Sandoz is a leading player in the global generics industry. This, together with our intensive product filing activities, means we are frequently inspected. It is essential that we pass each and every test, to keep products on the market and to ensure business continuity.

With headquarters in Germany and major production sites in Europe, Canada, the US, Brazil, Argentina and India, Sandoz is committed to the pharmaceutical standards and requirements of bodies ranging from the European Union regulatory authorities through the US Food and Drug Administration (FDA) to the World Health Organization’s Good Manufacturing Practice (GMP) guidelines.

Rigorous internal standards

Sandoz is a leading player in the global generics industry. This, together with our intensive product filing activities, means we are frequently inspected. It is essential that we pass each and every test, to keep products on the market and to ensure business continuity.

Clinical trials

Sandoz is committed to optimizing the therapeutic use of established medicines. To this end, we have performed several clinical trials for major antibiotics in accordance with Good Clinical Practice (GCP) guidelines.

Our international Medical Department carried out clinical trials involving antibiotic therapies for a number of well-known conditions, including chronic bronchitis, tonsillitis and stomach ulcers. The results of these studies were published in leading medical journals or presented at international scientific meetings.

In Austria, for example, Sandoz was the first company to demonstrate – in two large multi-center studies - the effectiveness of a twice-daily administration of antibiotic amoxicillin. The result, which showed that a twice-daily dosage was just effective as the standard three doses per day, contributed significantly to ensuring that patients take medicines the way they are supposed to (patient compliance).