As the pharmaceutical industry evolves, it becomes imperative to embrace sustainable and efficient manufacturing practices that minimize harm to the environment. This necessitates the development of comprehensive strategies capable of optimizing labor, input shortages, and evolving supply chain dynamics, all while ensuring sustainable growth. At Lupin, we recognize the significance of this imperative and remain unwavering in our pursuit of continuous improvement and innovation across all our manufacturing sites. Our unwavering commitment to excellence, teamwork, integrity, and customer satisfaction propels us to produce high-quality medicines that are affordable and sustainable.
Global Manufacturing Sites
Total Formulation Units
U.S. FDA Approved Sites
API Quantity
Our manufacturing capabilities transcend boundaries, spanning three significant continents, with our largest facilities strategically situated in Asia, North America, and South America. This expansive footprint, not only facilitates streamlined logistics, resource optimization, and local sourcing but also affords our company the vital geographical coverage needed to efficiently serve patients and bridge the healthcare gap in over 100 countries. Furthermore, this global presence empowers regional manufacturing sites to access invaluable tools, research, cutting-edge technologies, and raw materials that may not be readily available in their home countries.
In the dynamic and fiercely competitive landscape of global manufacturing, we distinguish ourselves by delivering high-quality, affordable medicines to our customers. This achievement is realized through our unwavering focus on energy efficiency, automation, digitization, and cost-effectiveness.
Our modern production facilities and processes are meticulously designed to adhere to rigorous regulatory standards. Regular inspections by national and international regulatory authorities guarantee compliance and instill confidence in the quality of our operations. Leveraging specialized tools and processes, we optimize manufacturing operations to ensure a consistent and dependable supply of medicines that promptly meets market demands.
To augment our manufacturing prowess further, we conducted a comprehensive five-day workshop in November 2022 at Lupin’s Pithampur facility. Attended by 30 participants from across our manufacturing sites, this workshop provided invaluable training on the best practices in manufacturing. Armed with this knowledge, we are dedicated to continually elevating our production processes, and maintaining our unwavering commitment to quality, all while remaining fiercely competitive in the global market.
Recent investments have also seen us expand our capacities in multiple areas, including the establishment of a high-potent product manufacturing block, a cuttingedge plant dedicated for Metered Dose Inhalers (MDI) and Dry Powder Inhalers (DPI), a state-of-the-art facility for Oral Solid Dose (OSD) formulations and injectables, and the significant expansion of our Biotech Drug Substance facility. To ensure higher manufacturing efficiency and unwavering quality, we embrace the implementation of Six Sigma and Lean methodologies.
We remain dedicated to improving our manufacturing operations, reducing costs, and increasing efficiency. We have strategically invested in state-of-the-art equipment, machinery, and advanced processes to achieve this. Here are some recent initiatives that demonstrate our commitment:
During the year, we undertook an extensive evaluation of our productivity norms relating to our workforce at the factories and rationalized the same in line with international peer benchmarks.
These initiatives underscore our commitment to operational excellence, cost reduction, and sustainability. We strive to enhance efficiency and drive long-term value through continuous improvement and smart investments.
The advent of Industry 4.0 is ushering in a transformative era in manufacturing. Automation, digitization, and artificial intelligence have emerged as powerful tools, providing a competitive edge by boosting efficiency, cutting costs, and delivering superior product quality. Embracing these technologies, Lupin remains at the forefront of the pharmaceutical industry, combining cutting-edge advancements with sustainable manufacturing practices.
Across our manufacturing facilities, we are bolstering our digital capabilities by implementing Industry 4.0 systems. Our Accelerated Digital & Analytics Performance Transformation (ADAPT) project has revolutionized our approach. By leveraging big data, we can now identify and address any potential lapses in our manufacturing process in real time. This project has been initiated at three key sites: Goa, Tarapur and Nagpur.
Project ADAPT has three specific goals centered around ensuring the deployment of high-potential Digital and Analytics (DNA) use cases to build a digitally robust organization with at-scale DNA capabilities and effective change management. These goals include:
We employ advanced analytics, digital twin simulations, and central data lake-based use cases to drive strategic interventions and optimization in critical areas, improving yield, efficiency, and overall productivity.
ADAPT interventions and technologies have yielded promising results. Real-time sensor data from our IIOT platform has been utilized to model utility equipment performance, significantly reducing consumption. In Tarapur and Goa, advanced modeling has pinpointed causes of low-yield variations, driving targeted improvements. Similar models are being developed for other products, enhancing productivity and quality.
To empower our workforce, we have embraced a gamified learning approach for standard operating procedures (SOPs). This interactive and engaging method enhances knowledge retention, ensuring effective training. Additionally, we have implemented a digital performance management system with an online KPI reporting tool, providing real-time visibility of our performance that enable us to stay on track and meet targets.
Beyond Project ADAPT, we continue implementing various technology-driven initiatives across our global manufacturing sites. These include deploying high-productivity cartons for streamlined feeding and automated barcode verification, vision systems for real-time inspection and sorting, and digitization for optimized production and inventory management.
Data analysis and artificial intelligence play pivotal roles in our operations. Vision systems analyze and select printed variable information, automatic weights checkers ensure precision, and IoT-enabled Overall Equipment Effectiveness (OEE) management systems drive operational excellence. Additionally, we are exploring the feasibility and applicability of the Oransys system solution while continuous improvement software simplifies kaizen management using Lean Six Sigma principles.
We have prioritized critical areas for immediate attention across all manufacturing sites and research facilities to enhance operational efficiency. Energy-efficient lighting, advanced pumping technologies, and renewable energy utilization have been deployed. Variable frequency drives (VFDs) and energy-efficient cooling systems are also part of our sustainability efforts.
We are actively transitioning to cleaner fuels, incorporating agricultural-waste biomass briquettes and natural gas. Additionally, we are gradually introducing fuel additives to optimize combustion efficiency in our boilers.
As we embrace the new manufacturing age, Lupin remains dedicated to technological innovation, sustainable practices, and continuous improvement. By leveraging cutting-edge advancements and upholding our commitment to excellence, we are poised for a future of manufacturing excellence.
We remain steadfast in our commitment to incorporating sustainability measures into our manufacturing processes, placing paramount importance on the expansion of our utilization of renewable hybrid power. The following initiatives have significantly contributed to accelerating the adoption of renewable energy:
Lupin maintains an unwavering commitment to quality throughout our manufacturing operations and all manufacturing site personnel are trained in Good Manufacturing Practices (GMP), ensuring excellence across the board.
We adhere to global regulatory standards set by FDA, EMA, and WHO, guided by our comprehensive Quality Policy and Management System. Regulatory compliance and data integrity are integral to our quality standards. Lupin’s apex quality and compliance governing body, the Global Quality Council Steering Committee (GQCSC), has continuous oversight over all global manufacturing operations. In addition to ensuring that all sites remain in a sustainable state of current Good Manufacturing Practice (cGMP) compliance, the GQCSC also ensures that comprehensive assessments are made to ensure the resolution of deficiencies identified. A team of 2,700 specialized quality management professionals drives the implementation of our Global Quality Action Plan, ensuring global standardization across our manufacturing sites quarterly.
Our Global Quality Council Steering Committee reviews site performance regularly, promoting continuous improvement. They are supported by our well-established Corporate Quality Assurance function. The function fosters collaboration between our research and manufacturing functions, ensuring a seamless integration of quality control.
Through ‘Quality First’ program, we embrace dynamic changes across our procedures, investigation methods, corrective action plans, training effectiveness, and product robustness. Through a series of initiatives such as SOP effectiveness, Lupin Walk the Talk, People Readiness, Investigation, CAPA/Training Effectiveness, Change Management, Training Program Reboot, and Product Robustness, we cultivate a pervasive “Quality First” mindset among all our dedicated employees.
observationsThis program serves as a testament to our unwavering commitment to elevating quality standards.
Investing in the continued success of ‘Quality First,’ we have introduced a range of new initiatives as of FY23. The eight initiatives were originally implemented at our Pithampur Unit-2 and it has become a fundamental pillar across all our manufacturing sites.
Lupin’s quality management systems are in alignment with the Corrective and Preventive Action (CAPA) process. Our approved CAPA plan effectively tackles failures, Out of Specification (OOS) results, deviations, internal audits, complaints, and inspections. We utilize the online Caliber QAMS system to monitor and track the implementation of corrective and preventive actions, ensuring their efficacy. This robust system enables us to address events comprehensively, identify root causes, and prevent future occurrences. Lupin’s unwavering commitment to quality shines through our seamless integration with CAPA, driving continual improvement and ensuring exceptional standards in our products.
Lupin has set a goal to enhance the robustness of our products by reducing process variation. To achieve this, we have focused on improving the process capability of all the critical quality attributes (CQAs) that fall below the 1.0 standard and this has decreased the batch rejection rates. To further improve process capability, we have identified over 250 CQAs across API and FML, out of which we have taken action on more than 150 CQAs.
Furthermore, we have identified 29 quality improvement projects across formulations and API sites and are conducting a detailed analysis of the processes. We have identified the root causes of variation for a few of these projects and initiated countermeasures to reduce variation. We are confident that our efforts will improve product robustness and customer satisfaction.
Our organization is dedicated to the World Class Labs program, which aims to achieve a Five Sigma level of quality in all laboratory operations. We have implemented comprehensive measures to minimize incidents leading to invalid Out of Specification (OOS) results or false rejections to achieve this. This includes advanced features like state-of-the-art glassware cleaning systems, automated mobile phase assembly, and segregated clean and unclean areas.
Additionally, we have invested in high-tech testing instruments and identified error categories to target specific areas for improvement. These initiatives create a safer and more efficient laboratory environment. Furthermore, we have introduced process innovations such as material kitting, dedicated mobile phase preparation, software upgrades, and monitoring systems to enhance column performance and reduce errors.
We are also currently implementing a Laboratory Information Management Software (LIMS) module at Lupin Quality Control Laboratory to streamline our processes.
Furthermore, we have installed best-in-class laboratory equipment such as ICPMS, LCMS, and GCMS at Lupin Tarapur to meet our in-house testing requirements and quality standards.
To enhance product quality, Lupin has embraced advanced technology and automation. This includes automated systems for quality monitoring, precision systems for discarding defective products, and camera and software-based technologies to optimize manufacturing processes.
Additionally, implementing electronic Batch Production Records (eBPR), systems streamlines compliance procedures, enhances operational efficiency, and reduces human error. These systems enable real-time monitoring, comprehensive analysis, and reporting of manufacturing activities, improving batch processing evaluation and analysis.
By streamlining processes and operations, Lupin reduces paper consumption and ensures data integrity and accuracy.
We had seven product recalls in FY23. At Lupin, we are proactive with our monitoring of potential product recalls and take the necessary steps to ensure their corrective actions are in place to address any issues.
Lastly, standardized routine management dashboards help monitor KPIs (backlog, OTIF, portfolio utilization, etc.) at each level. They also help in efficiently categorizing and extracting Production, Quality, and investigation data. These dashboards provide high-level summaries of essential metrics, support decision-making and ultimately allow more effective use of resources, and increase the quality of the product and effectiveness of operations.
Lupin is determined to combat counterfeit medicines and has implemented several measures to achieve this goal. One such measure uses a unique product identifier that includes a product code, serial number, batch number, and expiry date. Additionally, each bottle is induction sealed to prevent tampering and product contamination, and a 2D data matrix barcode encodes the unique identifier. Serialization and aggregation of all packing lines across all manufacturing plants are also being implemented to track and prevent the distribution of counterfeit products in the market.
Our Goa site has also implemented special initiatives to address counterfeit drugs in accordance with the EUFMD guidelines. In compliance with the delegated regulation on safety features, we use tamper-evident labels on all cartons intended for the European market. This enables visual verification of product packaging tampering, thereby enhancing patient safety.
Lupin’s Pharmacovigilance Department also known as Drug Safety and Risk Management (DSRM) has developed a robust Quality Management system adhering to global PV regulations. The dedicated pharmacovigilance team monitors the safety and quality of our products after they have been launched. The team identifies and tracks any safety and quality issues related to our products, taking appropriate actions to mitigate the risk and ensure patient safety. We closely track KPIs, including compliance with submission timelines for expedited and periodic reports to regulatory authorities like the U.S. FDA, Australia, Health Canada, EU, and India. These KPIs are reviewed monthly and presented in our GQCSC meetings, ensuring effective oversight of our regulatory commitments.
A dedicated pharmacovigilance team monitors the safety of Lupin’s products after they have been launched in the market. The team identifies and tracks any safety issues related to our products, taking appropriate actions to mitigate the risk and ensure patient safety. Below are the metrics for regulatory compliance of DSRM function:
At Lupin, regulatory compliance remains among the top priorities, and we are committed to meeting all applicable regulatory requirements in our countries of operation. Our facilities are periodically inspected and audited by regulatory authorities, our customers, and third-party consultants. This is further augmented by an established internal auditing mechanism and detailed SOPs defined in
our Quality System to ensure compliance and regulatory adherence. Lupin has obtained regulatory approvals to market its products in various countries, and we work closely with regulatory agencies to ensure the highest compliance standards are met.
Lupin is monitoring the below KPIs goals for regulatory compliance and quality:
Assurance Statement