As the prevalence of chronic as well as infectious diseases continue to surge globally, the demand for effective treatments and medications rise in tandem. At Lupin, we understand the transformative power of innovative pharmaceuticals developed through the integration of cutting-edge technologies, extensive research endeavors, and robust intellectual property protection. With unwavering dedication, our team of passionate scientists and employees tirelessly strive to drive significant advancements that align with our fundamental goal of reducing the burden posed by common and severe illnesses, ultimately enhancing overall health outcomes.
By investing in newer capabilities and building scientific acumen, we have enhanced the richness of our product portfolio to meet the diverse and complex needs of patients. Our business paradigm is premised on manufacturing medications of superior quality, affordability, and efficacy. This resounding commitment propels the advancement of our portfolio in critical areas such as injectables, inhalation, cardiovascular diseases, diabetes, respiratory illnesses, ophthalmology, central nervous system disorders, and oncology, solidifying our position as key players in healthcare innovation.
R&D Investments in FY23
R&D Units
Products Launched in U.S.
Formulations Patent Applications
Global Trademarks
Patents Secured in FY23
Active Patents and Patent Applications
R&D Personnel
API Patent Applications
Training Hours
Innovation lies at the center of all our efforts in creating and enhancing enterprise value and is reflected in Lupin’s Strategy and goals for innovation.
To attain leadership in APIs, complex generics, biosimilars, and specialty therapeutics.
Lupin’s relentless pursuit of excellence has yielded an impressive portfolio of Intellectual Property (IP) assets. To date, we have filed 463 Abbreviated New Drug Applications (ANDAs) and 11 New Drug Applications (NDAs), out of which 308 ANDAs and 10 NDAs have been approved by the U.S. FDA. This showcases our dedication to expanding and enhancing our product offerings, drawing from our extensive intellectual capital and expertise. We have moved up the complexity grid with our filings in Ophthalmic, Dermatology, inhalation, and injectable space with Micro/Nano emulsions & suspensions, preservative-free systems, metered dose pumps, DPI with proprietary devices, and multi-drug MDI, among others.
As a leading pharmaceutical company, the management of intellectual property (IP) lies at the very core of our business strategy, catalyzing the expansion of our product portfolio. We have implemented robust processes to effectively identify and safeguard our intellectual assets while proactively mitigating the risks associated with potential IP infringements. Driving these efforts is our Intellectual Property Management Group (IPMG), entrusted with the pivotal role of generating, securing, and capitalizing on cutting-edge research, thereby nurturing a high-value portfolio of patents, products, and research pipeline products.
In FY23, Lupin settled 10 U.S. patent litigations and one AU damages litigation.
Demonstrating our ongoing dedication to innovation, we filed a total of 245 patent applications during the year, comprising 79 formulations, 9 active pharmaceutical ingredients (APIs), 10 biotech, and 147 novel drug discovery and development (NDDD) applications. This resulted in the securing of 81 patents, adding to our extensive portfolio, which currently stands at 911 active patents and patent applications encompassing APIs, formulations, NDDD, and biotech.
Lupin’s continuous pursuit of innovation and our diligent respect for IP rights reinforce our position as a responsible and respected player in the pharmaceutical industry. We remain committed to contributing to the advancement of healthcare while upholding the principles of intellectual property protection.
At Lupin, patient centricity lies at the heart of our core business strategies. We are committed to delivering the highest quality drugs and this commitment is exemplified through our world-class R&D facilities. With a dedicated team of over 1,400 employees focused on developing innovative formulations, novel drug-delivery systems, and API synthesis technology, our R&D facilities serve as the epicenter of innovation at Lupin.
Lupin’s research facilities globally adhere to international standards, boasting cutting-edge infrastructure. Operating in diverse locations, these integrated centers leverage knowledge and foster innovation across scientific domains.
Through these facilities, our primary objective is to build a robust pipeline of innovative products for sustainable growth. This is supported by a strong internal audit framework ensuring regulatory compliance in R&D activities. Our scientists and employees stay abreast of regulatory and technological advancements, aligning with pharmacopeia methods and industry best practices to remain at the forefront.
Lupin has invested in biotechnology research to establish a strong biosimilar portfolio. Biosimilars are a key element of our growth strategy, enabling us to increase access to critical therapies in areas with significant medical needs.
We have one biosimilar filed with the U.S. FDA right now and 3 additional biosimilars in global clinical phase III trials. We also have Etanercept continuing to launch in various markets.
Our biosimilars target primary markets such as the United States, Europe, Japan, India, and other emerging markets. We pride ourselves on developing biosimilars that comply with the most stringent quality standards, ensuring they meet regulatory requirements in developed and emerging markets. We have gained market permissions through our partnership with Viatris and successfully commercialized biosimilar Etanercept (Nepexto®) in major EU markets. Etanercept is a complicated fusion protein, and Lupin is the only Indian company that has successfully manufactured it in-house. It is produced at our biotech facility in Pune, and the facility has undergone inspections and certifications from European and Japanese agencies recently. With approval from the Drug Controller General of India (DCGI), Lupin’s Etanercept has also been introduced in the Indian market. Similarly, we have launched our Pegfilgrastim and Ranibizumab molecules also in the Indian market.
Pegfilgrastim (Peg GCSF): We have reached a significant milestone after submitting our BLA (Biological License Application) to the U.S. FDA. Follow-on Peg GCSF On-Body Injector is in the advanced stages of development.
Ranibizumab: In global phase III clinical trial in wet age-related macular degeneration. Recruitment complete and awaiting follow-up.
Abifercept: In global phase III trial in wet age-related macular degeneration. Recruitment is ongoing.
Denosumab: In global phase III trial in osteoporosis. Recruitment is ongoing.
Lupin’s Novel Drug Discovery and Development (NDDD) team is dedicated to developing a portfolio of highly differentiated and innovative chemical entities in therapeutic areas such as Oncology.
Our oncology research focuses on targeted treatments based on specific gene mutations or alterations, irrespective of the cancer type. A clinical study involving terminally ill patients with melanoma, lung, and colon cancers has been completed in Europe. Additionally, a trial is underway in India to treat a refractory type of lung cancer with RAS mutations, for which no treatment options currently exist worldwide.
We continue to bolster our capabilities in novel research areas and inked a licensing and development partnership with AbbVie and Boehringer Ingelheim.
Through our NDDD efforts, Lupin remains committed to advancing innovative therapies in areas of high unmet medical need, aiming to improve patient outcomes and quality of life.
NaMuscla®, an orphan drug for treating myotonia in adults with non-dystrophic myotonic disorders, received EU marketing authorization in December 2018. The European Medicines Agency has approved it for managing symptomatic myotonia in adults with non-dystrophic myotonic disorders.
In January 2023, the Spanish Ministry of Health granted reimbursement approval for Lupin’s NaMuscla® (mexiletine) for the symptomatic treatment of myotonia in adults with non-dystrophic myotonic disorders. This makes NaMuscla® the first licensed pharmaceutical for this indication in Europe, with commercialization undertaken by Lupin’s partner, Exeltis, in Spain.
Health economic evaluations conducted in the UK, Norway, and other countries have demonstrated the clinical value and cost-effectiveness of NaMuscla®. Renowned Health Technology Assessment Agencies such as NICE in the UK, IQWIG in Germany, PBAC in Australia, NOMA in Norway, and the MSCBC in Spain have recognized its benefits for patients with non-dystrophic myotonic disorders.
Lupin is committed to generating and sharing clinical trial outcomes with stakeholders, including payors, regulators, healthcare professionals, and patient advocacy groups. Ongoing post-launch observational studies are being conducted to gather patient-level clinical research data, focusing on safety and effectiveness in adults and children. These studies are registered on www.clinicaltrials.gov.
We have dedicated Process Development capabilities focused on optimization at the sites focused on API and Formulation process improvement, thereby contributing towards improving the yield of existing as well as new molecules by simplifying processes, optimizing process ingredients, eliminating steps, or suggesting alternative synthesis (manufacturing) routes. In addition, to yield improvement, the process development also undertakes activities that result in higher yields, faster cycle time, and better quality of drug substances. Over the last four years, this has translated into a total of ₹870 Mn savings annually, improved yields and solvent recoveries to achieve ~1% reduction in API COGM, and a ~0.5% reduction in Formulation COGM on account of yield improvement and larger batch sizes for further reduction in conversion costs.
On the formulations end, Lupin has implemented several process improvement initiatives including:
The teams also focus on Green Chemistry for synthetic manufacturing processes. Hence, the design of high-yielding processes is such that byproducts are not pollutants or can be treated to eliminate pollution. Also, the processes are ensured to be atom efficient, and waste reduction, water reduction, solvent reduction, and time cycle reduction are continuously pursued.
At every point, the team has cascading pipeline of projects for optimization at various stages, from lab development to a regulatory filing. As a result of these endeavors, the average yield improvement delivered is ~20% over existing processes. In the same period, the most noteworthy improvements were seen in processes related to manufacturing 14 products for various markets such as the U.S., EU, China, etc.
These products included: Desvenlafaxine, Rifaxmin, Eslicabazepine, and Cephalexin, among others. The average process improvements achieved during the manufacturing of these products are given below:
Patents Secured
in FY23
Water Reduction
(Avg.)
Solvent / Reagent
Reduction (Avg.)
No. of Stages
Reduction (Avg.)
Capacity Improvement
(Avg.)
Solvent
Recovery
At Lupin, quality being a top priority, Impurity control is one of the most important tasks in a process scale-up. Our Process Development and R&D teams ensuring the delivery of robust processes, Control of input material attributes, control of in-process materials, product specifications, controls of unit operations, and thorough end product testing to address impurities. In the past few years, we have developed and filed patents for several processes for quality improvement, especially those around removing Nitrosamine and Genotoxic impurities.
Lupin firmly believes in harnessing the power of open innovation to accelerate its research and development (R&D) endeavors and achieve strategic goals. Open innovation entails collaborating with external partners to access novel knowledge, technologies, inventions, and markets. Lupin has embraced various open innovation approaches to enhance its capabilities and competitiveness within the pharmaceutical industry. Two notable examples highlight Lupin’s successful utilization of open innovation to create value for its stakeholders:
Through these strategic collaborations and open innovation initiatives, Lupin remains at the forefront of research and development, driving scientific advancements and creating value for its stakeholders.
Lupin proactively engages with peers, regulators, and industry associations to deliberate on an enabling framework for strengthening collaborations and strategic partnerships.
Lupin partners with DKSH to commercialize Alvotech’s biosimilars in the Philippines, expanding Multicare’s bone disease, oncology, immunology, and ophthalmology portfolio. This agreement strengthens Multicare’s offering of biosimilars and generic medicines in oncology, rheumatology, gastroenterology, and ophthalmology.
Lupin partners with Viatris to commercialize Lupin’s biosimilar etanercept in ex-U.S., ex-Canada, and ex-Japan markets. The agreement allows Lupin to launch its Etanercept in global markets, leveraging the wide commercial infrastructure of Viatris. The agreement is now assigned to Biocon as part of Viatris’s sale of its biosimilar business to Biocon. Lupin partners with Nichi Iko to commercialize Lupin’s biosimilar Etanercept in Japan. The agreement leverages Nichi Iko’s market-leading position in Japan to benefit Lupin’s biosimilar Etanercept.
Lupin partners with I’rom Group to conduct clinical trials, register, distribute, and exclusively market biosimilar Denosumab in Japan. Denosumab is used for treating osteoporosis in postmenopausal women at high risk of fracture and preventing skeletal-related events in patients with bone metastases from solid tumors.
Lupin prides itself on maintaining a robust and clearly defined Information Technology Security Organization guided by a dedicated Apex / Steering Committee. The Apex committee is headed by the MD, while the Steering committee is led by a Certified Information Security Manager (CISM) and includes key stakeholders comprising the Chief Financial officer, Chief Information Officer (CIO), Chief Information Security Officer (CISO), Legal Representative and a representative from human resources department. The primary objective of this committee is to effectively govern the actions and initiatives of the Information Security Organization, ensuring that roles and responsibilities within the hierarchy are clearly defined and executed with precision. By establishing this governance structure, Lupin proactively safeguards its I.T. infrastructure and strengthens its cybersecurity posture. This includes risk assessments, vulnerability management, incident response, and security awareness training.
Regular audits and assessments are conducted to evaluate our cybersecurity measures’ effectiveness and identify improvement areas. Compliance with relevant laws, regulations, and industry best practices is a key focus of our I.T./Cybersecurity Governance framework.
By establishing a well-defined I.T./Cybersecurity Governance framework, Lupin strengthens its ability to protect sensitive information, prevent cyber threats, and ensure our technology infrastructure’s overall resilience and reliability. We are committed to continually enhancing our governance practices to adapt to evolving cybersecurity risks and industry standards.
(CRO) – Executive Director,
Global CFO & Head – Corporate Affairs
(CIO) – Senior Vice President
(CISM) – Director, Corporate Affairs
(HR) – Vice President
(Legal) – Vice President
(CISO) – Senior General Manager
ISMS policy is available on Lupin’s intranet portal highlighting the company’s commitment towards information security in line with business/legal/regulatory needs. Additionally, SOP on security incidents and monitoring, policy on information classification, and incident management procedures are also available.
Employees who want to escalate any issue or report any security incident can raise their concerns at kavach@lupin.com or shield@lupin.com.
ISMS team periodically reviews performances at all the locations for timely completion of Kavach KPI and ranks the top 3 locations accordingly
In today’s digital world, where information and data hold immense value, safeguarding Intellectual Property Rights (IPR) is of paramount importance. At Lupin, we implemented robust strategies, systems, and processes to combat product piracy and counterfeiting and secure our valuable data.
Our comprehensive ISMS policy based on ISO 27001 framework serves as a foundation for managing and protecting data throughout the organization. The ISMS program, known as Kavach/Shield has been successfully implemented across the organization. As part of this implementation, we have created and published relevant security policies and procedures on the intranet portal accessible to all employees and third-party contractual.
To ensure the resilience of our critical operations during a crisis, we have established a business continuity plan (BCMS) in line with the ISO 22301 standard. In the initial phase, we conducted a thorough business impact analysis (BIA) and risk assessment (RA) for IT services at our Mumbai head office. The recovery strategy was validated through a tabletop exercise. Subsequent phases will involve conducting BIA and RA for four additional locations involved in research and development (R&D) and manufacturing, followed by other locations to be initiated in FY24.
We have obtained ISO/IEC 27001:2013 certification for our Indian Operations. This includes our Head Office, Research Park in Pune, and manufacturing sites including Pune Biotech, Ankleshwar, Tarapur, Goa, Aurangabad, Vizag, Nagpur, Sikkim, Mandideep and Pithampur. This certification ensures that Management Systems adhere to stringent standards. Our Information systems undergo periodic security assessments, at least once a year or as needed, to mitigate potential threats and vulnerabilities. We conduct both internal and external audits on an annual basis, and regularly updating the Steering Committee. We aspire to expand our ISO certification to cover global locations in the future.
By implementing these measures, we are steadfast in our commitment to protecting our Intellectual Property and ensuring the security of our organization’s valuable assets.
We are relentless in our pursuit of innovation, harnessing technology as a catalyst to enhance our systems, unlock the potential of our intellectual assets, and gain a decisive competitive edge. By embracing technology, we ensure superior healthcare solutions for patients and propel our compliance, operational, regulatory, and financial performance to new heights.
Lupin’s bedrock lies in our seamless integration of information technology services, anchored by robust systems such as SAP, our proprietary CRM, OpenText, diverse workflow solutions, SuccessFactors, and ModelN, among others. Our unwavering commitment to leveraging these systems enables us to advance organizational speed, agility, and decision-making prowess.
To further fortify our operational efficiency and risk management, we have successfully implemented the Kinaxis Demand & Supply planning tool, which empowers us to vigilantly monitor risks and seize opportunities across our entire organization. Additionally, through the deployment of Robotic Process Automation (RPA), we have automated labor-intensive processes related to sales returns and chargebacks, bolstering the efficiency of our shared services teams.
Recognizing the pivotal role of revenue visibility in the dynamic realm of generic medicine, we have adopted Oracle Performance Management tools for U.S. revenue planning. This strategic move reinforces our ability to navigate the intricacies of the market with precision and foresight.
Moreover, we have revolutionized our manufacturing processes by seamlessly integrating C-DAS (data acquisition from Programmable Logic Controllers and Supervisory Control and Data Acquisition systems), thereby enabling automation and streamlining production operations.
As part of our digitalization initiative, we are implementing continuous improvement software designed to capture and classify ideas, primarily focusing on enhancing employee engagement and simplifying Kaizen management. By leveraging our Lean-Six Sigma background, we aspire to foster a culture of innovation and excellence throughout our organization.
People and change management are crucial factors in influencing the success of digital transformation programs. We led a data science-based Ideathon + Hackathon to get Lupinytts on board with this transformation journey. Through Lupinnovate we urged all Lupinytts to submit ideas on how data may be used to improve business outcomes. This helped us cultivate capabilities, solicit ideas and promote an innovative culture at Lupin.
Lupin understands the need to stay ahead by embracing innovation and delivering affordable products in the ever-evolving pharmaceutical industry.
Central to this endeavor is the effective management of clinical data and utilizing Business Intelligence (BI) as a powerful tool. BI enables us to gain valuable insights, assess risks, and make informed decisions across our organization.
By consolidating complex data sets, we extract meaningful information through user-friendly dashboards, benefiting research and development, finance, and supply chain functions.
Our BI approach extends globally, with teams in multiple countries leveraging these powerful tools, including India, Australia, Philippines, Somerset, Mexico, the U.S., Brazil, South Africa, and Germany. This integration of BI throughout our organization enhances decision-making and drives overall performance.
Lyfe is a digital therapeutics solution developed by Lupin Digital Health, a subsidiary of Lupin, to provide comprehensive care for individuals with chronic cardiovascular diseases.
This innovative platform integrates human intelligence, artificial intelligence and machine learning to optimize patient outcomes and reshape the doctor-patient dynamic.
Developed in collaboration with renowned Indian cardiologists, Lyfe enhances doctor-patient collaboration by continuously monitoring health vitals, promoting therapy adherence, and boosting patient awareness. It utilizes FDA and CE-approved wearable devices to record vital parameters and promptly notify caregivers and doctors of any irregularities or emergencies.
With features such as medication reminders, round-the-clock emergency assistance, and access to a network of dedicated care managers, health coaches, and nutritionists, Lyfe empowers patients to actively manage their heart health while receiving personalized support and guidance. Lupin Digital Health aims to redefine cardiac care and enable individuals to take control of their health and overall well-being through Lyfe.
With a dual focus on environmental preservation and business profitability, we are committed to implementing sustainable technologies and practices throughout our operations. As part of our sustainability initiatives, we are proud to introduce Luforbec pMDI and, more recently, Beclu® pMDI, certified carbon-neutral inhalers specifically designed to treat adult asthma in the UK.
These breakthrough products is expected to offer a 30% NHS list price saving versus branded equivalents. This can result in potential savings for the NHS of £72 Mn per annum.
In addition to greater cost savings, Luforbec® is also a carbon-neutral product and recently received a carbon neutrality certificate from Carbon Footprint Ltd after a robust life cycle assessment (LCA). This is also expected to contribute greatly to the NHS and its green agenda to achieve net zero emissions.
This certification empowers healthcare professionals with a sustainable choice, enabling them to manage asthma patients in an environmentally conscious manner.
Lupin is transforming through data analytics, automation, and digital technologies. We use Industrial Internet of Things (IIoT), Robotic Process Automation (RPA), and data lakes to gather data from Enterprise Resource Planning (ERP), Manufacturing Execution Systems (MES), Laboratory Information Management Systems (LIMS), Internet of Things (IoT) devices, Customer Relationship Management (CRM) detailing, and secondary sales data.
The insights generated from data analytics are shared with stakeholders through Enterprise Business Intelligence (BI) platforms, allowing them to take informed actions.
Data analytics has already shown value in optimizing utility consumption, improving yield, and enhancing medical representative engagement. We’re scaling these use cases and focusing on strengthening Overall Equipment Efficiency (OEE), streamlining line changeovers, and implementing digital visualization for performance dashboards. Lupin is also gamifying learning and enhancing maintenance and monitoring activities.
Automation is also implemented for Annual Product Quality Review (APQR) and root cause analysis. Lupin has successfully automated over 100 processes across various departments, including finance, taxation, pharmacovigilance, manufacturing, supply chain, and IT using RPA bots.
Assurance Statement