Manufacturing
Capital

Real-Time, Data-Driven Manufacturing

At Nagpur Unit-1 OSD and Tarapur, we introduced Industrial Internet of Things (IIoT) video walls. These systems capture and display real-time operational parameters across compression, fluid bed drying (FBD), granulation, and coating machines — enabling teams to monitor deviations, optimize processes, and model rapid Advanced Analytics (AA) interventions. At Tarapur, equipment sensors feed directly into the IIoT ecosystem, allowing for predictive analysis and timely course correction.

The deployment of PAS-X MES dashboards transformed how we track batch progress. With automatic data refreshes every three hours, teams now make sharper decisions with better prioritization — all through a single, unified digital interface.

Enhanced Line Visibility and Performance Monitoring

We digitized three out of four packaging lines at Nagpur Unit-1 OSD, enabling real-time tracking of hourly production rates. This not only empowers on-ground teams with actionable insights but ensures faster corrective responses. We plan to scale this visibility to Somerset.

In Tarapur, time cycle e-log dashboards now span four plants, allowing real-time tracking of critical batches. Similar dashboards have gone live in our sites in Dabhasa and Ankleshwar — supporting shift transitions, enabling product-level robustness analytics, and enhancing overall throughput without compromising quality.

Integrated Command and Control

Our newly introduced Digital Performance Management Dashboard integrates KPIs across six core functions — Finance, Supply Chain, HR, Manufacturing, EHS, and Quality — offering leadership a bird’s-eye view of performance trends, bottlenecks, and improvement areas. This dashboard acts as a single source of truth for driving cross-functional alignment.

Smarter Yields Through Advanced Analytics

AA modeling was deployed on compression parameters for five key products at Nagpur Unit-1 OSD, resulting in significant yield improvements. With proven results, we are now scaling this initiative across the product spectrum at the facility.

Together, these interventions represent not just digital progress — but a profound cultural shift. One where data, technology, and people come together to redefine how we deliver consistent quality, faster turnarounds, and sustained operational excellence.

AI and GenAI Transformation

At Lupin, we are embracing Artificial Intelligence (AI) and Generative AI (GenAI) to drive smarter, faster, and more efficient operations across the value chain. Our AI initiatives are reshaping how we work, from field operations to manufacturing and compliance.

Smart Manufacturing Hub: AI-enabled insights for querying critical process and maintenance data, improving operational agility.

Quality Co-Author: Automates and accelerates documentation like SOPs and QRAs, ensuring compliance and efficiency.

OOS Navigator: Streamlines investigations with AI-driven root cause analysis and auto-generated reports.

Supply Chain Insights Hub: Provides real-time responses to market signals and disruptions, enhancing planning and resilience.

Driving Process Innovation by Integrating Green Chemistry Principles

At Lupin, we believe that process innovation is more than a pursuit of efficiency — it is an ethical imperative. We are reimagining manufacturing to balance business performance with environmental responsibility, embedding sustainability into the way we develop, refine, and scale every process. We have Process Development Laboratories at each of our manufacturing locations. These centers concentrate on refining processes to improve on new routes of synthesis, cost improvement processes, implement operations-friendly processes, and work on packaging development.

Our adoption of Green Chemistry principles reflects this approach. By prioritizing safer reagents, cleaner reactions, and smarter synthesis pathways, we aim to minimize waste at its source — not just manage it downstream. Metrics such as atom economy, E-factor, and Process Mass Intensity (PMI) guide us in selecting the most environmentally responsible routes.

In FY25, these principles translated into a meaningful outcome. For example, for a key molecule in the antidepressant class, we redesigned the resolution stage — optimizing raw material usage and improving selectivity. This change alone eliminated 57 metric tons of waste, significantly reducing the environmental footprint of a high-volume product without compromising yield or quality. This is just one example of how we embed the principles of green chemistry into our process development goals. We institutionalized this mindset by training our scientists across R&D and manufacturing on these principles, ensuring that sustainable design becomes the norm — not the exception.

Today, many of our development routes already demonstrate industry-leading sustainability metrics: E-factors under 100, improved atom economy, and lower PMI values. These initiatives reinforce our commitment to environmental protection.

For us, process innovation is not confined to cost or speed. It is about accountability — to regulators, to patients, and to future generations. Every optimization we undertake must uphold the highest standards of quality and compliance while advancing our collective responsibility to heal without harm.

Greener API Manufacturing Process

We redesigned the API (antidepressant category) production process, which previously relied on non-recoverable solvents and high-water usage. The new process helps in reduction of reaction steps and time, simplifies work-up, and delivers higher yields with exceptional purity. It also reduces impurities, including undesired isomers, and uses antioxidants for product stability.

Outcome: Output increased by 7%, water use dropped by 17%, and solvent use reduced by 33%. The process limits powder processing to the API stage, lowering costs. Incorporation of antioxidants prevents product degradation, ensuring high-quality output.

Safer and More Efficient Process Adoption

We replaced a multi-step process for manufacturing an API (Selective Cholesterol-Absorption Inhibitors). The replaced optimized process reduces organic/aqueous phase handling and simplifies production through telescoping of the process.

Outcome: Yield improved by 7%, waste decreased by 40%, water and solvent use dropped by 35%, and powder handling steps fell by 50%. The E-factor improved by 33% (from 5.86 to 3.96), marking a greener process.

More Efficient Redesigned Process Scale-Up

We transformed a 5-step process into a 3-step process for an API (Antidepressant-Class Drug). This process involved selective imine reduction with a metal catalyst to achieve a higher yield of a chirally pure product. This cuts batch testing, reduces solvent use by 40%, lowers water use by 30%, and decreases waste by 16%. The process mass index improves by 40%, and the E-factor drops from 16.5 to 7.96. Atom efficiency rises from 64% to 84%.

Outcome: Yield increased by 63%, raw material use reduced by 30%, and residue per kilogram of product decreased by 30%.

SOP Simplification and Harmonization

We simplified and harmonized key SOPs across our OSD formulation sites — spanning operations, PD labs, warehouses, and engineering services. The focus: reduce complexity, enhance clarity, and standardize processes across sites. These SOPs are now leaner, more intuitive, and better aligned to FDA, ICH, WHO, and EMA requirements. This effort significantly reduces human error risks, while ensuring site-to-site alignment and regulatory compliance. In FY26, we will extend this initiative to our API facilities and harmonize key SOPs for Quality, Operations, and Warehousing across both formulations and APIs.

Human Error Reduction at Lupin Biotech

At Lupin Biotech, we launched a structured human error reduction program, ‘Procedural and Human Error Reduction Protocol.’ It includes SOP identification, resource mapping, Gemba-based gap detection, and visual flowcharts for SOP key points. The approach fosters greater ownership among shopfloor teams, prevents avoidable deviations, and strengthens procedural compliance.

Capacity Expansion for Future Readiness

We expanded manufacturing infrastructure across key sites in order to strengthen our capacity. At our Tarapur facility, we have increased the intermediate product manufacturing capacity from 5 TPM to 12 TPM and one intermediate MPP5 plant upgraded to meet the cGMP requirements and made it dedicated for single product. Our Goa facility now houses a dedicated Microbiology Lab; LRP-Pune facility is equipped with a new Bioanalytical Lab; and our Pithampur HPD facility has been scaled to support larger volumes. At our Nagpur site, we expanded the injectables plant by adding an autoclave, cold rooms, clean storage areas, and increased rack capacity.

Recognition for Manufacturing Competitiveness

It is a matter of great pride for us that our Ankleshwar API and CSN formulation facilities received Gold Medals at the 11th National Awards for Manufacturing Competitiveness (NAMC 2024–25). The award recognized our non-conventional approaches, custom-fit strategies, and site-specific execution, rating us on ten parameters that define long-term manufacturing competitiveness. This honor reinforces our commitment to operational excellence, strategic agility, and delivering measurable value across the supply chain.

Sustainable Manufacturing

At Lupin, we believe that true healthcare progress must go hand-in-hand with environmental stewardship. Our manufacturing philosophy is anchored in sustainability — ensuring that every product we make contributes not just to individual health, but also to planetary well-being.

Environmental stewardship is part of our core. In FY25, we continued transitioning our operations to renewable energy, while optimizing resource consumption across our manufacturing network. From adopting energy-efficient lighting, advanced pumping systems, and sustainable cooling technologies to investing in low-carbon processes, every action was purpose-led to enhance ecosystem resilience.

All our Indian manufacturing and R&D sites, along with our Mumbai headquarters, are ISO 14001 and ISO 45001 certified while our international sites undergo rigorous internal assessments reaffirming our compliance with global environmental and occupational health and safety standards. These certifications reflect more than procedural rigor; they signal a deep and enduring commitment to responsible operations.

Our investments this year in renewable energy and decarbonization are a step toward long-term climate resilience — a reiteration of our culture, to always be sustainable, inclusive, and future-ready.

Our Tarapur API facility earned a Gold Award at the 10th India Green Manufacturing Challenge (IGMC), organized by the International Research Institute for Manufacturing (IRIM). Additionally, our Ankleshwar site successfully completed the GMEA assessment in May 2024. The site was recognized as a “Leader” and “Sustainability Front Runner,” by GMEA Assessment auditors.

Product Quality and Safety

Our quality management systems continue to serve as the guiding hand to our manufacturing processes. This year we have implemented newer assessment models and enhanced our quality management practices to ensure that the medication we produce is of the highest standards. Lupin has 16 laboratories out of 21, certified at 5S level across our regulated sites. We advanced technology solution implementation in our labs successfully. Lupin Goa won the technology leader of the year award at the Manufacturing Today Conference and Awards-2024 for its innovative automated Mobile phase preparation assembly project. We have also developed a methodology to monitor and improve HPLC utilization, achieving cost savings equivalent to 52 new HPLC.