OUR PRODUCTS

QUALITY STANDARDS

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We have built our reputation and renown global brand on the back of consistent and reliable delivery of high-quality healthcare products worldwide. Ensuring that our customers can trust us to act responsibly and to deliver safe and effective medicines at affordable costs, makes us who we are, setting us apart from the competition.

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 commitment, self-discipline, excellence and desire for continuous improvement. This philosophy is what makes Sandoz special and we will not settle for less. With these values in mind, we work diligently to exceed customer expectations and continuously look for new ways to improve our products and deliver greater value to patients.

External Regulatory Standards

Sandoz is a leading player in the global generics industry. As an industry leader, our products, processes and facilities are routinely inspected by worldwide regulatory authorities to ensure that they remain compliant with the cGMP (current Good Manufacturing Practice) and cGLP (current Good Laboratory Practice) guidelines outlined by the World Health Organization (WHO). It is absolutely critical that we meet these standards to ensure that our products always remain safe and ones upon which patients can continue to rely and trust.

With a development and production network across the Americas, Europe, Africa and Asia, Sandoz is committed to global cGMP and cGLP compliance. We also strive to adhere to all additional requirements requested by various world-wide regulatory bodies ranging from the European Medicines Agency (EMA) through to the U.S. Food and Drug Administration (FDA).

Rigorous Internal Standards

Sandoz has its own internal quality system that ensures adherence to stringent quality standards in development, production and commercial distribution. Our pharmacovigilance system is aligned to that of Novartis and these rigorous standards apply globally throughout the organization to employees and partners alike. These same standards apply equally to all marketed products, whose safety profile is regularly monitored by our Clinical Safety Department through periodic medical quality reports that are also submitted to relevant health authorities worldwide.

These standards are based on a fundamental commitment to quality that is engrained within our culture and embraced by our entire workforce. We also expect each of our partners and suppliers to share in this commitment, and strive to ensure that they meet these same standards through our worldwide supplier qualification program.

Post-Marketing Studies and Clinical Trials

At Sandoz, we are dedicated to optimizing the therapeutic use of existing medicines and innovating existing therapies where possible. Sandoz has performed several post-marketing studies, also known as phase IV clinical trials, for major antibiotics in accordance with Good Clinical Practice (GCP) guidelines.

Our international Medical Department has carried out a number of trials involving various antibiotic therapies for a number of well-known conditions, including chronic bronchitis, tonsillitis and stomach ulcers, the results of which have been published in leading medical journals and/or presented at international scientific meetings. In two large multi-center studies in Austria, for example, Sandoz was the first company to demonstrate the effectiveness of a twice-daily administration of antibiotic amoxicillin, versus the then current standard of three doses per day. Such innovations in existing product therapies contribute significantly to patient healthcare, with results that include increased patient compliance and thus greater effectiveness of treatment.

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Pioneering Biosimilars

Sandoz is the pioneer and undisputed global leader in the rapidly emerging market for biosimilars. Visit our stand-alone Biosimilars website to find out more

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Frequently Asked Questions

Everything you wanted to know about the generics industry. More