Our unwavering commitment to manufacturing excellence is at the very core of our foundation in our quest towards sustainable manufacturing practices and providing the best healthcare solutions for our patients. Enhanced efficiencies, adherence to high standards for product quality and regulatory compliance are the hallmarks of our manufacturing excellence as we set new benchmarks in the industry.
At Lupin, we have made significant investments to boost our manufacturing capital. These investments focus on enhancing our manufacturing infrastructure for both Active Pharmaceutical Ingredient and formulation products. This catalyzes our strategy to achieve optimal levels of resource deployment, productivity, operational efficiencies, sourcing, supply chain and logistics. We have also made significant strides in harnessing the power of technology to bolster our capabilities.
With 15 cGMP-compliant manufacturing facilities spanning three continents, we have established a robust foundation in pursuance of our goal to deliver affordable and high-quality medicines worldwide. These facilities adhere to the highest national and international standards, ensuring the quality, safety and efficacy of our pharmaceutical products. Additionally, by leveraging the Contract Manufacturing Organization model, we have unlocked a host of benefits, such as improved resource allocation, higher cost savings, expanded production capacities, and enhanced output.
Our manufacturing approach is driven by commitment to quality and continuous improvement. We have periodic upgradations to ensure that our equipment and machinery are state-of-the-art, backed by advanced processes. Some of our strategic investments during the year include
Continuous process innovation is a priority at Lupin. Our teams in API and Formulation sites work to optimize manufacturing processes for existing and new drug molecules. Their efforts streamline processes, improve yield, productivity, quality, and reduce cycle times. These efforts are also aligned towards optimizing manufacturing costs and enabling strict adherence with regulatory standards, ultimately enabling us to deliver high-quality, affordable medicines to patients worldwide.
Some of the process innovations in our sites that demonstrate our commitment to continuous improvement include
We developed an improved process to manufacture an API (ACE inhibitor class drug) which minimizes the use of hazardous reagents and solvents, and also reduces solid waste generated.
Outcome 19% increase in overall yield, 82% and 100% reduction in solvent and water usage respectively, and overall decrease in testing load for quality control from 22 to 14 samples per batch.We have replaced the traditional process of manufacturing an antiretroviral API with a simple LUPIN LIMITED | Integrated Report 2023-2024 80 chemical deprotection process using an alkaline alcoholic solution at atmospheric pressure.
Outcome This new process enables 15% yield improvement, lower water usage, better solvent recovery and reduced waste generation, making it a viable and market-competitive optionWe redesigned the traditional 5-step manufacturing process into a 3-step process for manufacturing an API (antidepressant class drug). This process involved selective reduction of the imine with a metal catalyst to achieve a higher yield of chirally pure product.
Outcome 63% higher yield, 30% reduction in raw material usage, and 30% lesser residue per kilogram of product manufacturedWe reformulated an antidepressant drug product to control the generation of nitrosoamine impurity in the final drug product and optimize raw material consumption.
Outcome The revised formulation reduces the generation of nitrosamine impurity in the drug and also helps reduce the overall consumption of inactive excipients by 20%. This reduction in excipient weight also enables significant savingsA) Tablets Coating Optimization We redeveloped the coating process of an anti-epileptic drug formulation product using purified water instead of solvents.
Outcome Following variation filings and approvals, this change has been implemented for commercial batch manufacturing. Using water instead of solvents during the coating process is environmentally friendly and enables savings.
B) Packing optimization to reduce waste We changed the packing design for one of our gel products by reducing the carton size.
Outcome The optimal reduction in carton size has resulted in decreased waste generation and has potential savings.At Lupin, our focus has been on enabling sustainable manufacturing operations. We have continued transitioning to renewable energy sources across our sites. Additionally, we have moved to the usage of energy-efficient lighting and pumping technologies, installed Variable Frequency Drives and adopted energy efficient cooling systems. All our manufacturing and R&D sites in India, as well as our headquarters in Mumbai, are certified for ISO 14001 and ISO 45001, highlighting our commitment to the environment. We invested a sizable amount of CAPEX during renewables and decarbonizing manufacturing processes in FY24.
Patient safety is at the core of everything we do. We remain committed to delivering top-quality products to our patients.
Ensuring Good Manufacturing Practices
Quality Management System
Our approach to quality management is led by a team of 2,700 specialists who drive the execution
of our Global Quality Action Plan. This holistic strategy fosters standardization across all our
global manufacturing sites under a unified quality system. Our Global Quality Council Steering
Committee oversees our quality-focused operations and ensures continuous improvement. We have
also appointed a Chief Quality Officer, marking our commitment to excellence in everything we
do. Our robust quality management systems, coupled with our quality-first culture driven by
strong governance frameworks, have helped us consistently deliver on our quality commitments.
Our Quality Management System enables resource management and quality control across the entire product lifecycle and involves periodic reviews at manufacturing sites, business units, and with our senior personnel. We continue to take great pride in the World Class Labs program, to elevate all laboratory operations to Five Sigma. Furthermore, we have installed laboratory equipment such as Inductively Coupled Plasma Mass Spectrometry, Liquid Chromatography Mass Spectrometry, and Gas Chromatography/Mass Spectrometry across eight sites. This infrastructure enables us to meet our stringent in-house testing requirements and quality standards effectively.
Our Process Development and R&D teams ensure the delivery of robust processes, control input material attributes, manage in-process materials, define product specifications, oversee unit operations, and conduct thorough end-product testing prior to product release. In recent years, we have developed and filed patents for several processes aimed at quality improvement, particularly in the removal of Nitrosamine and Genotoxic impurities.
We are committed to driving continuous improvements across our products and processes by focusing on critical quality attributes and minimizing process variations. This has led to the development of an optimized process model that consistently operates at sigma levels 4 and above.
Regulatory Compliance
We continue to prioritize regulatory compliance and ensure that we adhere to regulatory
benchmarks
in all the regions we operate. We have committed to a target of zero warning letters/OAI issues
by
FY25. Our progression towards our target has been significant as we continue to have only one
site
that was issued a warning letter during our last inspection cycle. We continue to monitor the
following KPI’s to ensure we are on track to reaching our goals:
| Inspections | FY23 Results | FY24 Results | Target |
|---|---|---|---|
| U.S. FDA Inspection (including GMP and Bioresearch center) | 9 | 9 |
Zero sites with WL/OAI status by FY25 (Currently two sites under WL) Zero data integrity related observations |
| No. of Form 483 | 7 | 2 | |
| No. of Total Observations | 55 | 3 | |
| U.S. FDA Inspection (including GMP and Bioresearch center) Warning Letters | 1 | 1 |
| Recalls | FY23 Results | FY24 Results | Target |
|---|---|---|---|
| Class 1 | 0 | 1 |
Zero class 1 recalls |
| Class 2/3 | 7 | 7 |
| Inspections | FY23 Results | FY24 Results | Target |
|---|---|---|---|
| Corporate Internal Audit on Lupin sites | 16 | 17 | Driven by Lupin’s internal quality metrics, all India sites are to be audited at least once a year by an internal audit team to ensure compliance and audit preparedness |
| Total supplier quality audits (Third party finished product site) for India markets | 74 | 64 | Driven by supplier quality metrics, every supplier site is audited once every three years and at the time of new vendor qualification |
| Total supplier quality audits (Third party finished product site) for U.S. markets | 6 | 3 | |
| Total supplier quality audits (raw materials) for all markets | 250 | 265 | |
| Training for Data Integrity, SOPs and CGMP conducted across all Manufacturing Sites | 6385 | 10090 | 100% of applicable employees |
With greater adoption of artificial intelligence, automation and digitization, the manufacturing landscape is continuously evolving. Leveraging cutting-edge technologies and sustainable manufacturing practices to stay ahead and drive excellence is paramount to us. Through the launch of the Accelerated Digital & Analytics Performance Transformation project, we have been able to harness big data and systematically assess any lapses in our manufacturing process in real time.
The results have been promising over the financial year, with substantial savings through project ADAPT, marking another successful year for the initiative and a show of continued excellence from our operations team. We have implemented advanced automation tools such as centrifuge automation, controlled feeding for the harvesting, profile-based automation and automation based level measurement systems to enhance product quality, avoid recalls and drive our overall commitment to enhancing quality at an organizational level. Here are some of the achievements we have made over the inancial year through Project ADAPT.
At Lupin, we are committed to combating the problem of counterfeit drugs to ensure product integrity and bolster patient safety measures. We implement anti-counterfeit measures, such as tamper evident labels, unique identifiers and QR codes, along with robust transportation tracking systems and chain of custody documentation, for products being rolled out from our manufacturing sites.
Lupin’s Drug Safety and Risk Management team utilizes a quality management system adhering to pharmacovigilance regulations. It vigilantly monitors the safety and quality of our products post-launch, identifying and addressing any safety related issues.
We track key performance indicators, including compliance with submission deadlines for expedited and periodic reports to regulatory authorities such as the U.S. FDA, TGA Australia, Health Canada, Drug Controller General of India, and UK MHRA, among others. These KPIs undergo a monthly review and are presented during our Global Quality Council Steering Committee meetings to ensure governance over our regulatory obligations.
This year, we have introduced the Parenteral Drug Ninja-X App Program Associations Education Courses and Skill Development Program. 34 employees participated in this training, which included theoretical training and practical demonstrations with case studies. The training program was delivered by subject matter experts with extensive industry experience. Trainees were supervised daily and provided with one-on-one training for a more holistic understanding.
The PDA initiative provides a unique platform that makes science-based learning simple, effective, and practical to translate into practice.In order to enable continuous learning across our sites and offices in India, Lupin deployed the Ninja-X mobile and desktop app in FY24. Ninja-X is a comprehensive learning platform enabling organizations to build training modules based on various topics. We at Lupin have created modules for our integrated manufacturing processes.
By earning points, badges, and rewards, employees are encouraged to actively participate and push for further improvement in their conceptual understanding of different operational and non-operational procedures. The gamified aspect of Ninja-X introduces an element of excitement and motivation in the learning process, promoting camaraderie and healthy competition amongst colleagues and further enriching the learning journey.
Assurance Statement