We continue to be at the forefront of fulfilling the needs of our patients globally. This, along with our enhanced understanding of the global health profile, has enabled us to focus on areas with high disease burden. Our teams are dedicated to rigorous testing, filing, and regulatory approval processes for our novel, complex, biosimilars and specialty drug developments. We focus on bringing these innovative healthcare solutions to the market while adhering to the highest standards of quality, safety and compliance to local and international standards. Sustainable research and development are at the core of our business as we continue to collaborate with partners and institutions globally.
| Focus Area | Theme | Goal Description | Target | Target Year | Progress |
|---|---|---|---|---|---|
Innovation |
Product Launches | Complex inhalation products | 10 | 2028 | 1 |
| Complex injectables | 5 | 2028 | 1 | ||
| Ophthalmology, Dermatology and Women’s Health | 5 | 2028 | 1 | ||
| Product Portfolio | Portfolio should be more than 70% complex dosage forms | 70% | 2024 | 74% goal achieved | |
| Biosimilar and Novel Complex Products | Complete Biosimilar filings in regulated markets | 3 | 2028 |
|
Research and Development plays a critical role in the creation of healthcare solutions. We have seven research centres spread across five countries – India (Pune and Aurangabad), the U.S. (New Jersey and Florida), Mexico, Brazil and the Netherlands. These centers undertake extensive market research and evaluation of disease trends and patient needs to develop affordable and quality medicines.
Our team of 1400+ employees has constantly shared knowledge with the industry at large. In FY24, we published five research papers on projects conducted in our sites, showcasing our commitment towards developing innovative patient treatments.The company continues to invest in furthering research with revenue inflow to maximize our potential. Last year, we had a spend of INR 15,265 Mn, 7.8% of our annual revenues, to bolster our research and development programs, a testament to our commitment to continuous innovation. This has led to the direct addition of 1,211 drugs to our existing product portfolio.
The company continues to invest in furthering research with revenue inflow to maximize our potential. Last year, we had a spend of INR 15,265 Mn, 7.8% of our annual revenues, to bolster our research and development programs, a testament to our commitment to continuous innovation. This has led to the direct addition of 1,211 drugs to our existing product portfolio.
| Type of Filling | FY22 | FY23 | FY24 | |||
|---|---|---|---|---|---|---|
| Fillings | Approvals | Fillings | Approvals | Fillings | Approvals | |
| NDA | 1 | 2 | 3 | 3 | 0 | 1 |
| ANDA & ANDS | 19 | 9 | 28 | 17 | 12 | 42 |
| Total | 20 | 1 | 31 | 20 | 12 | 43 |
Protection and management of Intellectual Property is crucial to our business strategy. Our stringent policies and robust governance processes enable us to identify and safeguard our assets against any breach of information and mitigate any risk associated with infringements. Our Code of Business Conduct and Ethics Policy ensures that all our employees are aware of our commitment to protecting intellectual property.
We have a diverse and constantly evolving product portfolio that has seen the addition of 34 generic dossiers across the U.S., Canada, Europe, Australia, Philippines, India and our Global Institutional Business. Driving these initiatives is our Intellectual Property Management Group, that upholds the creation and safety of our IP, as well as pioneer research, building a valuable portfolio of patents, products, and a robust research pipeline.
With these filings, our portfolio now stands at 440 active patents out of 866 patent applications, comprising of APIs, formulations, NDDD, and biotech. These patents represent our mission to bring the best-in-class medicines to our patients.
We have continued to invest in and expand our biosimilar portfolio in FY24, in line with our growth strategy and business objectives. Our biosimilars are aimed at key markets, including the U.S., Europe, Japan, India, and other emerging regions. We also signed up for the commercialization of a biosimilar in the MENA region. We take pride in developing biosimilars that adhere to the highest quality standards, ensuring they meet regulatory requirements in both developed and emerging markets. We continue to expand access to our biosimilars in developed and new markets. This year, we signed an exclusive licensing agreement with Amman Pharma for exclusive marketing and commercialization of Ranibizumab, a biosimilar of Lucentis®, in the MENA region.
Our Novel Drug Discovery and Development team continues to focus on accelerating new drug discoveries and bringing them to commercialization. Since its inception, the NDDD team has focused on three key therapeutic areas - oncology, immunology and metabolic disorders. We have continued to advance our discovery programs by fostering partnerships with leading pharmaceutical companies. In July 2023, we secured funding from our development partners at AbbVie to initiate phase 1 clinical trials for the MALT 1 (Mucosa-Associated Lymphoid Tissue Lymphoma Translocation Protein 1) inhibitor program for treatments across a range of hematological cancers that are hard to treat. This has been a significant step in getting this formulation to market and demonstrates our continued commitment to ensuring positive health outcomes for our patients.
Lupin is the first company to introduce DIFIZMA®, the only fixed-dose combination (FDC) dry powder inhalation product for the treatment of inadequately controlled Asthma. This FDC combines Indacaterol, a long acting beta agonist, Glycopyrronium, a long acting muscarinic receptor antagonist, and Mometasone Furoate, an inhaled corticosteroid.
We have been exploring the power of technology to drive innovation and transform drug discovery, development, and delivery. By integrating cutting-edge technologies such as artificial intelligence, machine learning, and genomics, we aim to accelerate the identification of new drugs and create more patient-centric solutions. Our collaborations seek to unlock the value of enterprise data, enhancing efficiencies and helping to expedite innovation across all functions and processes, including manufacturing, testing, supply chain, finance and accounting.
The implementation of SAP Fiori apps has significantly improved the user experience for our employees, offering simple, easy to access data models and analytical reports.
In our Indian operations, we have harnessed Robotic Process Automation and advanced analytical tools such as Qlik Sense to automate critical tasks. Enhancements to our Qlik Sense dashboards have promoted business transparency and facilitated data-driven decision making, enabling integrated data utilization and providing meaningful insights in a user friendly manner.
Furthermore, we have globally implemented an innovative end-to-end supply planning tool, marking a significant advancement in optimizing supply chain operations and enhancing organizational efficiencies. This tool seamlessly integrates with our ERP system, providing a unified platform that automates planning activities for both demand and supply sides, delivering a touchless planning experience.
Lupin is accelerating the use of green chemistry to reduce the generation of hazardous substances. We have been achieving this by applying metrics such as atom economy and e-factor. An example of this is an antiviral molecule; the earlier process involved three steps, and the overall yield was found to be 0.91% with an e-factor of 88 and an atom economy of 35%. The improved process involves one step and a yield of 1.4%. E-factor has improved by almost 90% (8.0) and atom economy by 58% (80%).
We aim to incorporate 12 principles of green chemistry and have conducted programs and trained process development scientists on principles pertaining to the same. This ensures that we do not focus our remediation efforts on end of life waste streams, but rather take on a proactive approach to the disposal of hazardous materials. We intend to expand this to include more processes and chemicals in the coming years. Using telescoping principles, lean processes for 17 leadership molecules (API) were transformed, and isolations at intermittent steps were eliminated. The optimal use of water and solvents in the process has helped in the reduction of both aqueous effluents and the number of organic solvents mix. The use of statistical tools (DoE) to develop and optimize chemistry has also enabled us to explore new design spaces. The manufacturing API’s overall cycle time has been reduced.
To transform the batch processes for one of our high volume APIs, our team has embarked on a journey to gradually transition from batch process to continuous manufacturing and has witnessed benefits such as shorter processing times, increased safety and efficiency, and a reduced environmental footprint. This has resulted in the reduction of manual intervention and overhead expenses. Furthermore, process designs through biotechnological routes and enzymatic catalysis have enabled us to catalyze numerous chemical reactions for molecules such as Cephalexin, Eslicarbazepine, and Rifampicin, as an alternative to classical chemical synthesis. This is a testament to our efforts to provide business value.
Our partners are at the crux of our innovation journey. Open innovation involves partnering with external entities to acquire new knowledge, technologies, inventions, and study market opportunities. Lupin has adopted multiple open innovation strategies to strengthen its capabilities for ESG commitment on partnerships and competitiveness in the pharmaceutical industry.
Therapy for Highly Drug-Resistant TB
TB Alliance granted Lupin a non-exclusive license to
manufacture the anti-TB drug Pretomanid as part
of the three-drug “BPaL” regimen. Lupin has initiated
commercialization of the anti-tuberculosis medicine in
approximately 140 countries and territories, including
many of the highest TB burden countries around the world.
In today’s interconnected digital landscape, information security management and protection have become paramount concerns for organizations worldwide. We are committed to upholding the highest standards of information security across our operations and have a comprehensive approach to safeguarding our information assets.
Elevating Information Security in Digital Age
Lupin prioritizes the security of its sensitive information
through a robust Information Security Management
System. This framework provides a structured approach
to proactively identify, assess, and mitigate information
security risks. By adhering to industry best practices, the
ISMS ensures the confidentiality, integrity, and availability
of critical data assets.
Our commitment to cybersecurity extends beyond policy implementation. We leverage advanced technologies like Zero Trust and network monitoring tools, particularly at the plant level, to bolster our defenses. Additionally, the strategic deployment of honeypots at the perimeter aligns seamlessly with CERT-IN standards. This multilayered approach has yielded positive results, with zero major security incidents reported this year.
Furthermore, Lupin demonstrates its dedication to continuous improvement by achieving ISO 27001:2013 certification across all India locations, including our headquarters. We are currently transitioning to the latest standard, ISO 27001:2022. This proactive approach ensures our security practices remain aligned with evolving threats and regulatory requirements, enabling us to adapt effectively.
Overview
In a rapidly evolving digital landscape, Safeguarding Operational Technology networks is
paramount. Our project aimed to fortify cybersecurity by implementing cutting-edge
anomaly detection techniques and integrating threat intelligence feeds. The goal was to
proactively identify and mitigate potential threats to uphold integrity, availability,
and reliability of critical industrial processes.
We deployed advanced anomaly detection systems within our OT network. These systems monitored network traffic without disrupting manufacturing operations, analyzing patterns to identify any unusual behaviors signaling security threats swiftly.
Engaging with equipment manufacturers, business teams, and security consultants was crucial. Together, we ensured that the threat intelligence feeds were finely tuned to the unique needs of each plant. This collaborative effort maximized the effectiveness of our cybersecurity measures.
Real-time anomaly detection empowered us to swiftly respond to potential threats, minimizing their impact on critical processes.
By raising awareness about cybersecurity threats, we fostered a culture of vigilance across our organization.
Proactive threat mitigation led to minimal operational disruptions, ensuring seamless manufacturing continuity.
Early risk mitigation translated to significant cost savings, preventing the need for extensive system repairs and downtime.
To ensure the resilience of our critical operations in times of crisis, we have established a Business Continuity Management System in alignment with the ISO 22301 standard. In the initial phase, we conducted a comprehensive Business Impact Analysis and Risk Assessment specifically for IT services in our Head office. The recovery strategy was then validated through a tabletop exercise. Subsequent phases will involve conducting BIA and RA for four additional locations engaged in Research and Development and manufacturing.
Assurance Statement