Viatris Inc

Performance in the 2026 Benchmark

Mid-performing. Viatris performs at a mid-level in Responsible Manufacturing as it reports the level of compliance with discharge limits achieved at its own and suppliers’ sites but not publicly. It is also mid-performing in Appropriate Access & Stewardship, where its efforts are mixed. Viatris shows strong efforts in mitigating stockouts and shortages of its products in LMICs, monitoring patient reach and implementing access strategies for seven of its off-patent medicines. However, it does not implement product-specific stewardship strategies and registers its off-patent products in fewer countries than other assessed generic medicine manufacturers. 

Opportunities for Viatris

Expand appropriate access to paediatric formulations of its antibacterial and antifungal medicines. Viatris registers its off-patent antibacterial and antifungal medicines in an average of six LMICs, yet the company does not always register child-friendly formulations in all of these countries. It can bridge this gap and expand access to paediatric formulations of its medicines by registering them and implementing appropriate access strategies in at least the same countries where it already registers the corresponding adult formulations. 

Scale up its responsible sales practices and strengthen its governance of interactions with healthcare professionals. Viatris already fully decouples incentives for its sales agents from sales volume targets for some branded medicines and does not deploy sales agents for its generic portfolio. To ensure responsible sales practices company-wide, it can extend this decoupling to all branded antibacterial and antifungal medicines or stop deploying sales agents for these medicines altogether. Moreover, Viatris can strengthen its public policy governing interactions with healthcare professionals (HCPs), and thereby address appropriate use of its antimicrobials, by including provisions to ensure a legitimate need for such interactions; mitigate potential conflicts of interest – specifically between employees and HCPs; limit transfers of value and ensure these are paid at fair market value. 

Ensure compliance with discharge limits directly in wastewater and improve transparency on levels of compliance achieved by its suppliers. Viatris reports 100% compliance with discharge limits set in the receiving environment for its own products, based on mass balance estimations, but only 77% compliance for its suppliers’ high-volume products.  To further safeguard AMR risk from antibacterial manufacturing, it can publicly report compliance with discharge limits directly in wastewater for all its own and suppliers’ products and require supplier compliance through contractual provisions –  a step beyond its current practice of setting discharge limits in receiving waters – in line with the ‘stringent’ WHO guidance. 

Changes since November 2023 update report on previous Benchmark opportunities

• Viatris has earned three BSI Kitemark™ Certifications under the AMR Industry Alliance (AMRIA) Manufacturing Standard. Two are for products manufactured at its site in Aurangabad, India, and the other is for a product manufactured at its site in Troisdorf, Germany. 

• In 2024, Viatris contributed to the publication of the AMRIA Equitable and Responsible Access Roadmap as the co-chair of the AMRIA Access working group.  

• In November 2025, Viatris announced a research collaboration agreement with Locus Biosciences to develop newly engineered bacteriophage products for ophthalmic bacterial infections – conditions associated with rising rates of AMR. 

Sales & operations

• Therapeutic areas: Anaesthetics, anti-infectives, cardiovascular, central nervous system, dermatology, diabetes, eyecare, gastroenterology, immunology, oncology, respiratory diseases & allergies, women's health

• Product categories: Generic medicines

• Investments in AMR: No notable investments identified.

• M&A news: In June 2024, Viatris completed the divestment of its API Business in India to Matrix Pharma Private Limited.

Sample of portfolio assessed by the Benchmark

Performance by Research Area

Responsible Manufacturing

Mid-performing. Reports a comprehensive environmental risk management strategy aimed at mitigating AMR risk at both its own and suppliers’ sites. It reports on the level of compliance achieved across both its own and suppliers’ sites. Viatris does not report incorporating AMR provisions into supplier contracts. It publicly discloses its quantification methods but not the level of compliance achieved across its supply chain. 

Mitigates AMR risk at both its own sites and suppliers’ sites; reports 100% of antibacterials compliant with discharge limits for own sites, tracks compliance of antibacterials for supplier sites. Viatris’ comprehensive environmental risk management is based on the AMR Industry Alliance Antibiotic Manufacturing Standard (Industry Standard). It reports implementing ZLD systems at some sites, with recycled water not being released into the environment, though the number of sites is not disclosed. It quantifies bacterial discharge annually at its own sites using mass balance estimation and chemical analysis. Quantification is based on 24-hour discharge levels and in cases where PNECs are exceeded, CAPAs are implemented. Viatris reports 100% of its antibacterial products comply with discharge limits in the receiving environment, where wastewater is already diluted, which means that AMR risks present in wastewater may not be fully captured. Three sites have received BSI Kitemark™ certifications for ciprofloxacin, pretomanid and clindamycin. The company requires suppliers to follow the Industry Standard, and it reviews discharge levels through audits. Viatris reports 77% of the antibacterial products manufactured by its suppliers comply with PNECs in the receiving environment, representing over 90% of its third-party produced antibacterial volume, but the exact number of products is provided under an NDA. No information is available on whether Viatris engages with external waste treatment plants to mitigate AMR risks from manufacturing.   

Publicly discloses basic details of its AMR mitigation strategy but is not publicly transparent about compliance with discharge limits. Viatris publicly reports implementing the Industry Standard and quantifying discharge levels using mass balance estimation. For both its own sites and its suppliers’ sites, it publicly reports conducting audits on PNEC compliance, but the audit results with the actual discharge levels are not publicly disclosed, nor is the number of products complying with PNECs or the names and locations of manufacturing sites for each antibacterial product.

Appropriate Access & Stewardship

Mid-performing. Shows strong performance in ensuring continuous supply, as it has a comprehensive approach to mitigate stockouts and shortages and ensures GMP compliance at own and suppliers’ sites. It also performs well in implementing appropriate access strategies, particularly for seven out of nine of its off-patent medicines, and using a standardised methodology for calculating patient reach. However, its stewardship strategies are limited to general policies across its portfolio. Viatris’ performance on registration is inconsistent; on average, it registers on-patent medicines more widely and off-patent medicines less widely than peers. 

Viatris registers its on-patent medicines more widely than its peers, although its off-patent medicines are registered less extensively. 

Viatris registers its on-patent medicines in 13 countries* and its off-patent medicines in 6 countries. In a few countries where it registers its on- and off-patent medicines, it also registers paediatric formulations. Its on- and off-patent Reserve antibiotics and medicines targeting MDR-TB are registered in 12 countries, including 5 countries where the corresponding disease burden is high. For some of its medicines, Viatris engages in WHO’s Prequalification process, facilitating registrations in a total of 4 countries   

^{*All numbers in this statement are expressed as an average of the products selected for analysis and refer to registrations in the 113 countries in scope for ‘access metrics’.} 

Average performance, with access strategies for 2 of 3 on-patent products assessed, but limited stewardship efforts. Viatris provides access to 2 of the assessed products, delamanid (Deltyba®) and pretomanid (Dovprela®) – both key anti-TB drugs included in WHO-recommended regimens – through supranational procurement via the Stop TB Partnership’s Global Drug Facility. The company also supplies delamanid, which has been licensed from originator company Otsuka, via a national tender in a country in scope of the Benchmark. Viatris reports using a methodology to measure patient reach for all 3 products, providing the number of patients reached through its access strategies in the country for delamanid and pretomanid. The company only reports a stewardship strategy for pretomanid, including the Pretomanid Resistance Surveillance Programme – which is a collaborative effort with the TB Alliance – as part of the post-marketing surveillance requirements. Viatris also funded a surveillance study in India, sharing the data available in an open-access journal article. 

Above-average performance, implementing and monitoring access strategies for 7 of 9 off-patent/generic products assessed, but limited stewardship efforts. Viatris reports access strategies for 7 products assessed, all focused on the same country included in the Benchmark’s scope. One product, linezolid, has a comprehensive access strategy, through which it is supplied via both national and supranational channels. The other 6 products are supplied exclusively in the private market. Viatris reports using a standardised methodology to measure patient reach and provides the number of patients reached for all 9 products. Viatris applies general stewardship policies across its portfolio, including responsible promotion. 

Strong efforts to mitigate stockouts/shortages. Strong reported evidence of systems to ensure product quality. Viatris implements demand planning and data sharing through a 24-month forecast horizon. Its Rapid Response Advanced Planning system is updated daily and provides supply and demand information to key stakeholders, including commercial, warehousing and supply chain teams. It maintains buffer stocks of critical APIs and finished products, with higher safety stock levels for high-risk items based on demand volatility, supply instability and lead times. Inventory levels are monitored through its automated Rapid Response Advanced Planning system which alerts global operations on potential shortages. Its supplier diversification strategies implement dual sourcing for certain products and local sourcing. It mitigates substandard and falsified medicines by verifying suppliers through GMP audits, reporting incidents to relevant authorities and implementing security features, such as serialised barcodes and track-and-trace systems. It reports that 26/26 of its own sites and all its ~500 supplier sites are GMP compliant. However, it does not implement additional quality measures in countries with evolving regulatory systems.

Includes elements to address appropriate across its business practices. Viatris does not deploy sales agents to sell and/or promote its generic antibacterial and antifungal medicines to HCPs. For branded antibacterial and antifungal medicines, Viatris applies a different sales model, with information on this provided under an NDA. However, for some of these products, Viatris reports either full decoupling of incentives for its sales agents from sales volume targets or refraining from promoting them in the majority of countries.  Through its global public policy, Viatris ensures that interactions with HCPs are ethical. However, it does not include specific provisions supporting the appropriate use of antibacterial and antifungal medicines. Viatris voluntarily discloses information on transfers of value (ToVs) publicly in Serbia. The company does apply its public policy to third parties working on its behalf, although it is unclear if it does so for its sales incentive plan.   

Active in 1 multinational AMR surveillance programme and involvement in 1 study. While Viatris is not assessed for its activities in AMR surveillance as a generic medicine manufacturer, its involvement in 1 AMR surveillance programme and 1 study was identified during the period of analysis. Viatris collaborates with the TB Alliance for the 'Pretomanid Resistance Surveillance Programme', which is part of its post-marketing surveillance requirements and ended in 2025. The programme covers 1 genus of bacterial pathogens, 1 antibacterial medicine and 8 countries. There is no evidence of data sharing during the period of analysis. In addition, Viatris funded a multicenter, retrospective, observational study in India. Aggregated data from this study has been shared in an open-access journal article. The methods used to collect surveillance data are unclear for the observational study and have not been reported for the surveillance programme.