Sandoz and Teva Achieve Independent Certification for Steps to Minimise Antimicrobial Resistance Risk
Certification demonstrates their commitment to protecting people and planet
9 November – Sandoz and TEVA have become the first organizations to be certified as meeting an international standard on the Minimized Risk of Antimicrobial Resistance (AMR), demonstrating that they are taking necessary steps to ensure antibiotics are made responsibly, helping to minimize the risk of aquatic toxicity in the environment and the spread of AMR.
The new global Minimized Risk of Antimicrobial Resistance (AMR) certification was developed by BSI, the business improvement and standards company, to confirm the responsible manufacturing of antibiotics in the global supply chain. Following the certification program’s launch in June, a range of antibiotic products have now successfully completed the certification process within each of the organizations.
The BSI Kitemark for minimized risk of antimicrobial resistance provides independent third-party verification of the steps being taken to ensure that waste streams containing antibiotic active pharmaceutical ingredient (API) and drug products are appropriately controlled during manufacturing. It involves an initial evaluation against the requirements of a designated standard and will be maintained by annual surveillance to verify ongoing maintenance of the appropriate controls. Like all BSI certification programs, it is rigorous and challenging for organizations to achieve.
Courtney Soulsby, BSI Global Director, Healthcare Sustainability, said: “Controlling waste discharge of antibiotics from manufacturing can help retain the long-term effectiveness of antibiotics to treat infections, keeping medicine effective, boosting patient safety, and supporting a cleaner ecosystem. It’s fantastic to see Sandoz and TEVA achieve certification, making clear their commitment to ensuring antibiotic manufacturing meets the best available scientific and environmental standards. Taking this critical step forward to address the growing threat from AMR and reduce discharge into the environment can help us accelerate progress towards a sustainable world.”
The program was launched following the publication of the globally applicable industry standard in June 2022, facilitated by BSI for the AMR Industry Alliance, an organization made up of over 100 companies and associations from across the life-sciences industry with the shared goal of providing sustainable solutions to curb AMR. AMR Industry Alliance members are among the first to seek certification, which is open to all manufacturers to tackle one of the many ways that AMR spreads in the environment.
Discharge of antibiotics from manufacturing processes into the surrounding environment is one of several factors that may contribute to the development and transmission of AMR in nature, including in humans. According to the World Health Organization (WHO), AMR is one of the top 10 global public health threats, while the UN Environment Programme (UNEP) has concluded that “the environment plays a key role in the development, transmission and spread of AMR.”
Boumediene Soufi, Head of Sandoz AMR Program, said: “This first-of-a-kind certification demonstrates that Sandoz, the global leader in generic antibiotic medicines, is taking the necessary steps to ensure responsible manufacturing of these critical medicines – a key pillar of the global AMR response strategy.”
Amalia Adler-Waxman, SVP, Global Head, ESG, Teva said: “At Teva, we are proud to partner with the AMR Industry Alliance and BSI to support responsible manufacturing across the pharmaceutical supply chain— to help ensure a healthy future for people and the planet.”
For more information on the AMR standard and certification program, visit: Antimicrobial resistance (AMR) and how standardization is driving change | BSI (bsigroup.com).
Sandoz (SIX: SDZ; OTCQX: SDZNY) is the global leader in generic and biosimilar medicines, with a growth strategy driven by its Purpose: pioneering access for patients. 22,000 people of more than 100 nationalities work together to bring Sandoz medicines to some 500 million patients worldwide, generating substantial global healthcare savings and an even larger total social impact. Its leading portfolio of more than 1500 products addresses diseases from the common cold to cancer. Headquartered in Basel, Switzerland, Sandoz traces its heritage back to the year 1886. Its history of breakthroughs includes Calcium Sandoz in 1929, the world’s first oral penicillin in 1951, and the world’s first biosimilar in 2006. In 2022, Sandoz achieved sales of USD 9.1 billion and core EBITDA of USD 1.9 billion.
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has been developing and producing medicines to improve people’s lives for more than a century. We are a global leader in generic and innovative medicines with a portfolio consisting of over 3,500 products in nearly every therapeutic area. Around 200 million people around the world take a Teva medicine every day, and are served by one of the largest and most complex supply chains in the pharmaceutical industry. Along with our established presence in generics, we have significant innovative research and operations supporting our growing portfolio of innovative medicines and biopharmaceutical products. Learn more at http://www.tevapharm.com.
About AMR Alliance
The AMR Industry Alliance is one of the largest private sector coalitions created to provide sustainable solutions to curb antimicrobial resistance, with over 100 biotech, diagnostics, generics and research-based pharmaceutical companies and associations joining forces. Alliance members represent the major sub-sectors across the life-sciences industry and have come together toward a common goal to fight AMR. The Alliance is focused on facilitating action in four key areas: access, appropriate use, research & science, and manufacturing.
The AMR Industry Alliance has been a leader in developing and leading implementation of guidance for manufacturers to control emissions of active pharmaceutical ingredients for antibiotics in production wastewater and scale responsible manufacturing practices. Among others, this work has been recognized by the G7 Health Ministers, who also committed to working with the Alliance and other stakeholders to agree to and mainstream standards.