Gufic BioSciences Ltd Management Discussions

INDUSTRY STRUCTURE AND DEVELOPMENTS:

The pharmaceutical industry is a highly regulated, research-intensive sector responsible for the discovery, development, manufacturing and marketing of medicines for the prevention, treatment and management of diseases. The industrys value chain broadly comprises four stages: research and development (R&D), manufacturing, marketing and distribution, and regulatory oversight.

At its core, R&D drives innovation, beginning with basic research to identify new drug targets, followed by preclinical testing in laboratories and animals and progressing through multi-phase clinical trials to evaluate safety and efficacy in humans. This process is capital-intensive, time-consuming and high-risk, but remains the foundation for the introduction of new therapies.

Manufacturing involves the production of active pharmaceutical ingredients (APIs) and their formulation into finished dosage forms, supported by rigorous quality control and adherence to Good Manufacturing Practices (GMP). API production is frequently outsourced to specialized manufacturers-particularly in India and China-while final formulation and packaging may be undertaken closer to the target market.

Marketing and distribution employ a mix of traditional channels, such as medical representative-led engagement with healthcare professionals and modern approaches, including digital platforms and patient engagement initiatives. Distribution networks encompass wholesalers, retail pharmacies, hospitals and increasingly, e-pharmacies catering directly to consumers.

The industry operates under stringent oversight by regulatory authorities such as the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and Indias Central Drugs Standard Control Organization (CDSCO). Recent years have seen a global push toward harmonized regulations to accelerate approvals and maintain quality standards.

Over the past decade, transformative developments have reshaped the sector. Breakthroughs such as mRNA vaccine technology, cell and gene therapies, CRISPR-based interventions and AI-enabled drug discovery are redefining possibilities in medicine. The market is shifting toward high-value specialty products, generics and biosimilars are expanding as patents expire and emerging markets are becoming major growth hubs. Faster regulatory pathways, drug pricing reforms and domestic manufacturing incentives are also influencing the competitive landscape.

Global events-particularly the COVID-19 pandemic have highlighted the importance of supply chain resilience, pandemic preparedness and digital health integration, such as remote patient monitoring. Simultaneously, sustainability objectives are prompting companies to embrace greener, more efficient manufacturing practices. Looking ahead, the industry is expected to deepen its focus on personalized and precision medicine, strengthen collaborations between pharmaceutical and technology players and integrate digital therapeutics as complementary treatment solutions.

GLOBAL PHARMACEUTICAL INDUSTRY:

The global pharmaceutical market remains a vital and dynamic pillar of the healthcare sector. According to Precedence Research (February 2025), the market was valued at approximately USD 1.6 trillion in 2023 and is poised for sustained growth-projected to reach USD 1.8 trillion by 2026 and USD 2.3 trillion by 2028 (at list price levels), reflecting a compound annual growth rate (CAGR) of 5–8%. Looking further ahead, the market is expected to reach USD 2.8 trillion by 2033, supported by a 6.15% CAGR between 2025 and 2034.

The pharmaceutical manufacturing segment is following a similar upward trajectory, driven by continuous innovation, increased outsourcing and globalization of supply chains.

As per the Global Economic Prospects Report (January 2025), global economic growth stabilized at an estimated 2.7% in 2024 and is expected to maintain this pace through 2025–2026. With inflation nearing target levels and monetary easing supporting economic activity, both advanced and emerging economies are positioned for steady expansion—providing a favourable macroeconomic backdrop for the pharmaceutical sector.

Key Growth Drivers: Several structural and market factors underpin the sustained expansion of the global pharmaceutical industry:

- Rising Prevalence of Diseases – An expanding global population and increasing incidence of chronic illnesses such as cancer, diabetes, cardiovascular and neurological disorders, alongside emerging infectious diseases, are driving sustained demand.

- Advancements in Medical Technology – Breakthroughs in drug discovery and development, such as the rapid adoption of GLP-1 receptor agonists for obesity and diabetes management, are fuelling prescription growth.

- Expanding Healthcare Infrastructure – Ongoing investments in healthcare systems, particularly across emerging markets, are improving access to medicines and broadening patient reach.

- Technological Integration - The adoption of AI, machine learning and digital platforms is enhancing R&D productivity, operational efficiency and clinical decision-making.

Major Global Trends: Various studies suggests that the pharmaceutical landscape is evolving rapidly, shaped by several megatrends, as specified below:

- Digitalization and AI: Artificial intelligence is revolutionizing drug development, clinical trial management and patient engagement. Generative AI tools are being adopted to enhance customer experience and accelerate discovery timelines. Moreover, Industry 4.0 technologies are enabling smart manufacturing and robust supply chain operations.

- Precision Medicine: Innovations in genomics, CRISPR and molecular diagnostics are paving the way for more targeted, personalized treatments, shifting the industry away from a one-size-fits-all approach.

- Supply Chain Resilience: Post-COVID-19, companies are focusing on localizing and diversifying production to mitigate risks associated with global disruptions and reduce dependence on single-source suppliers.

- Shift to Value-Driven Products: The market is transitioning from volume-based generics to high-value segments such as specialty generics, biosimilars and complex biologics, offering better margins and patient outcomes.

- R&D and Innovation Focus: The industry remains deeply innovation-driven with global biopharmaceutical R&D spending estimated at $198 billion in 2020. Over 9,000 drug candidates are currently in development globally, with companies targeting breakthrough areas such as CAR-T cell therapy, mRNA platforms and complex small molecules.

- Biosimilars and Biologics Growth: As patents for major biologics expire the biosimilars market is expected to reach $100 billion by 2030. Biologics themselves are projected to make up 55% of total pharmaceutical sales by the end of the decade, with global biotech spending surpassing $890 billion by 2028.

- CDMO and CRO Expansion: Contract Development and Manufacturing Organizations (CDMOs) and Contract Research Organizations (CROs) are becoming essential to pharmaceutical pipelines. The global CDMO market, valued at $146.05 billion in 2023 is projected to reach $315.08 billion by 2034 while the broader CDMO and CRO market could hit $355 billion by 2030.

- Regulatory Shifts and Pricing Pressures: Initiatives such as the U.S. Inflation Reduction Act are putting pressure on drug prices, affecting revenue models. However, efforts toward regulatory harmonization across global markets are helping to streamline approval processes and expand access.

- Patient-Centricity: There is growing emphasis on personalized medicine and digital engagement with healthcare increasingly designed around the individual patients experience and needs across the treatment journey.

Competitive Landscape: The pharmaceutical manufacturing industry is highly competitive, driven by continuous innovation, evolving regulatory requirements and the constant challenge of patent expirations.

- Leading Global Players: Key multinational companies dominate the market with extensive R&D operations, diverse product portfolios and global distribution capabilities. This includes, Pfizer Inc., Novartis AG, Roche Holding AG, Sanofi S.A., Merck & Co., Inc., GlaxoSmithKline (GSK), Johnson & Johnson, AstraZeneca.

- Generics and Contract Manufacturers: Generic drug manufacturers - particularly in India and China - play a pivotal role by offering cost-effective alternatives. Contract Manufacturing Organizations (CMOs) also contribute significantly by providing specialized, scalable manufacturing services to pharma companies worldwide.

Regional Dynamics: According to the IQVIA Institute – Global Use of Medicines 2024, regional markets demonstrate distinct growth drivers and capabilities:

- North America remains the worlds largest pharmaceutical market led by the U.S. Its advanced infrastructure, strong regulatory environment and high R&D spending make it a hub for first-in-class drug launches.

- Europe continues to uphold high manufacturing standards, with countries like Germany, the UK and Switzerland contributing significantly to global drug production and exports.

- Asia-Pacific particularly India and China is emerging as a global powerhouse in generic drug manufacturing and outsourcing. India aims to scale its pharmaceutical industry to $450 billion by 2047 while China is projected to grow volume and spending by over 20% and 21% respectively within five years.

- Latin America and Africa are experiencing accelerated growth driven by expanding healthcare access, supportive government policies and increased demand for essential medicines.

INDIAN PHARMA INDUSTRY – AN OVERVIEW:

The Indian pharmaceutical industry is a vital pillar of the countrys economy and a prominent force in the global healthcare landscape. Often hailed as the "Pharmacy of the World" India is the largest global supplier of generic medicines, accounting for approximately 20% of global generic drug exports. In fact, one in every five generic medicines consumed globally originates from India.

India is the largest provider of generic drugs globally and is known for its affordable vaccines and generic medications. The Indian Pharmaceutical industry is currently ranked third in pharmaceutical production by volume after evolving over time into a thriving industry growing at a CAGR of 9.43% since the past nine years. Generic drugs, over-the-counter medications, bulk drugs, vaccines, contract research & manufacturing, biosimilars and biologics are some of the major segments of the Indian pharma industry. India has highest number of pharmaceutical manufacturing facilities that comply with the US Food and Drug Administration (USFDA) and has 500 API producers that make for around 8% of the worldwide API market.1

India also holds a dominant position in vaccine production, contributing to around 60% of the total global vaccine supply as of 2021. This includes a wide range of essential immunizations used in both developed and developing nations. Notably, India meets nearly 50% of Africas demand for generic pharmaceuticals and fulfills approximately 40% of the United States generic drug requirements.

The industrys reach is supported by a robust manufacturing infrastructure, a large pool of skilled scientists and professionals, and a cost-effective production ecosystem. Indian pharmaceutical companies are not only major exporters but also active participants in contract manufacturing, R&D and clinical trials, further strengthening their global influence

With its strong capabilities in affordable medicine production, biotechnology and Active Pharmaceutical Ingredient (API) manufacturing, India continues to play a critical role in ensuring equitable access to healthcare across the world.

The Indian pharmaceutical market was valued at approximately USD 55 billion in 2023 though estimates vary slightly, with some sources citing figures between USD 50 billion and USD 58 billion. Despite the variation, consensus points to a rapidly expanding industry. Projections indicate the market could grow to USD 120–130 billion by 2030, driven by increased domestic demand, global exports, and growing investments in innovation and infrastructure.

Looking ahead to 2047 which marks Indias centenary of independence, the pharmaceutical industry has set an ambitious target of reaching USD 400-450 billion in market value. Achieving this would not only solidify Indias status as the "Pharmacy of the World" but also place the country among the top five nations globally in terms of pharmaceutical export value.

Currently, pharmaceutical exports account for around 6% of Indias total merchandise exports by value. This figure is expected to rise to approximately 7% by 2047, reflecting the increasing global reliance on Indias cost-effective, high-quality pharmaceutical products.2

Market Size and Projections

The Indian Pharmaceutical Market (IPM) registered a year-on-year growth of 7.7% in the financial year 2024–25, with a three- year compound annual growth rate (CAGR) of 8.8%. The overall market size reached approximately ?2.30 lakh crore. Both chronic and acute therapy segments showed improved performance compared to the previous year highlighting robust demand across the healthcare spectrum.

Chronic Therapies

Chronic therapies grew by 10.4% while acute therapies expanded by 7.9%-an improvement over the previous fiscal. Notably, Indian pharmaceutical companies outpaced multinational corporations (MNCs) in growth, further establishing the competitiveness of domestic firms.

Within the chronic therapy segment, oncology led with an impressive growth rate of 19.6%, followed by urology at 13.6%. Other areas such as chronic pain, cardiac care, and respiratory therapies posted strong double-digit growth of 11.8%, 11.1%, and 10.2% respectively. Meanwhile, neurology and hormone therapies recorded more modest single-digit growth rates of 9.0% and 8.2% respectively, with diabetes growing by 7.4%. The overall growth in the chronic segment was primarily driven by the strong performance of cardiac, oncology, urology, and chronic pain therapies. The individual performances of Chronic therapies are as below:

Cardiac Segment: The cardiac therapy segment posted a value CAGR of 11.1% and a unit CAGR of 2.2% in FY 2024–25, reflecting sustained growth in one of the largest chronic categories. Statins and hypotensive drugs, which together contribute nearly 50% of total cardiac sales, grew by 11.3%, underscoring their dominance in this segment. Other therapeutic classes within cardiac care, such as beta-blockers and angiotensin II receptor blockers (ARBs), recorded more modest single-digit growth. Meanwhile, the anticoagulants market grew by 10% propelled mainly by strong performances from Ticagrelor, which rose by 20%, and Apixaban, which surged by 44%.

Anti-Diabetes Segment: The anti-diabetes market recorded a value CAGR of 7.4% and a unit CAGR of 1.4%. Traditional

1- HYPERLINK "http://www.ibef.org/industry/pharmaceutical-india"

2- Pharmaceuticals Industry Report – Feb 2025

oral anti-diabetics such as the Glimepiride + Metformin combination saw moderate growth of 4.9%. However, significant momentum was observed in the Dapagliflozin and its combination therapies, which experienced a surge in demand following patent expiry leading to a wave of new product launches. The insulin segment maintained steady progress with a 4.7% growth, while GLP-1 (Glucagon-like Peptide-1) agonists delivered exceptional performance, growing by 55%, reflecting increasing adoption of newer and more effective treatment options.

Respiratory Segment: The respiratory therapy segment demonstrated solid performance with a value CAGR of 10.2% and a unit CAGR of 3.9%. Growth was largely driven by the inhalation preparations market, which expanded by 13.3%, contributing significantly to the overall strength of the chronic respiratory category. Among oral treatments, the Montelukast and combinations market grew by 5.4%, while Montelukast + Levocetirizine combinations posted a 3.8% CAGR. New combinations like Bilastine + Montelukast continued their upward trajectory, achieving an impressive growth of 18.7%.

Neurology / Central Nervous System (CNS) Segment: The neurology and CNS segment grew at a value CAGR of 9.0%, although it experienced a slight unit de-growth of -0.3%, indicating rising therapy costs or a shift toward higher-value formulations. Anti-depressants and anti-epileptics, which together account for 51% of CNS sales, recorded growth rates of 7.7% and 9.7%, respectively. Within anti-epileptics, Brivaracetam stood out with a remarkable 39% growth, highlighting its growing acceptance in clinical practice.

Acute Therapies

Amongst the acute therapies, Vaccines and Hepatoprotectives recorded strong growth, registering increases of 12.6% and 12.5% respectively. Despite operating on a high base, Anti-Infectives, Gastrointestinal therapies, and Vitamin, Minerals & Nutrients (VMN) posted single-digit growth, indicating relatively moderate performance. Acute Respiratory drugs showed subdued momentum, with a low growth of just 3%. In contrast, Parenteral drugs gained significant traction, emerging as a strong performer with a growth rate of 14.7%. The detailed break-up of the Acute segment is as follows.

Anti-Infective: The Anti-Infective therapy area recorded a MAT value CAGR of 7.2%, though it saw a slight unit de-growth of -0.9%. Cephalosporins, which account for 43% of the total Anti-Infective market, grew in line with the overall segment at 7.2%, serving as a major growth driver. Significant contributions also came from Systemic Anti-Fungals and Tetracyclines, which posted strong growth of 26% and 17% respectively. Additionally, the Carbapenem market witnessed high growth, primarily driven by increased demand for Faropenem, Meropenem and its combinations with Sulbactam.

Acute Pain: The Acute Pain segment showed a MAT value CAGR of 8.5% despite a unit de-growth of -1.0%. Anti-rheumatic and NSAID drugs, which form the core of this category with a 65% market share, grew by 8%. Muscle Relaxants though on a smaller base, posted a solid 10% growth. Meanwhile, Narcotic preparations and General Anaesthetics saw impressive growth of 26% and 31% respectively, albeit from a relatively low base contributing positively to the overall therapy performance.

Acute Respiratory: Acute Respiratory therapies underperformed relative to other acute categories, with a MAT value CAGR of only 3% and a notable unit de-growth of -4.4%. The largest sub-segment, Cough preparations, which make up 50% of the therapy, grew marginally by just 1.4%, significantly dragging down overall segment performance. Cold preparations showed minimal growth of 0.5%, while Antihistamines were a bright spot with a 6.5% increase.

Gastrointestinal: The Gastrointestinal segment delivered a relatively strong performance with a MAT value CAGR of 9.2% and a unit CAGR of 2.2%. Antipeptic ulcerants, which represent 40% of the segments value, grew by 7.5%. Laxatives demonstrated robust momentum with an 11.4% growth rate. Among individual molecules, Pantoprazole and its combination with Domperidone continued to show healthy double-digit growth of 10% and 7.5% respectively, even while operating on a high base.3

Key Strengths and Contributions

- Manufacturing Powerhouse: India has established itself as a global pharmaceutical manufacturing leader with more than 10,000 manufacturing facilities and over 3,000 pharma companies. It also has 650 US-FDA-compliant plants-the highest number outside the United States making it the third-largest producer of drugs and pharmaceuticals by volume globally.

- Active Pharmaceutical Ingredients (APIs): India is the worlds third-largest producer of APIs and contributes around 57% of the APIs on the WHOs prequalified list. This positions India as a vital supplier in the global pharmaceutical supply chain.

- Trade Surplus: Indias pharmaceutical sector continues to be a strong contributor to foreign trade, generating a healthy trade surplus of US$19 billion, a significant rise from the US$15.81 billion recorded in FY22.

- Employment: The industry plays a pivotal role in supporting employment providing livelihoods to approximately 2.7 million people both directly and indirectly.

- Cost-Effectiveness & Quality: India is globally recognized for producing high-quality medicines at affordable prices, earning the title of the "pharmacy of the world." More than 55% of Indias pharmaceutical exports are destined for highly

3. IQVIA – Indian Pharmaceuticals Market MAT Jan-25 Dataset egulated international markets, underscoring the trust placed in its products.

Megatrends Shaping Indian Pharma

- Supply Chain Resilience: The COVID-19 pandemic exposed vulnerabilities in global supply chains, prompting developed nations to localize or near-shore pharmaceutical production. Initiatives like the US Bio Secure Act are aimed at reducing dependency on single-source countries, particularly China. This shift presents a major opportunity for India, given its strong service levels, cost advantages, and deep talent pool.

- No Compromise on R&D and Quality: Top Indian pharmaceutical companies are boosting R&D investment, with a focus on high-value products and the development of New Chemical Entities (NCEs) and New Biological Entities (NBEs). At the same time, India is strengthening its compliance with global quality standards. Notably, the US-FDAs Official Action Indicated (OAI) rates for Indian facilities have declined from 19% in 2013 to 9% in 2023. Additionally, revisions to Schedule M introduced in 2023 are expected to further enhance regulatory adherence.

- Shift toward Value through CDMOs / CROs: Global pharmaceutical companies are increasingly outsourcing research, development, and clinical trials to Indian Contract Development and Manufacturing Organizations (CDMOs) and Contract Research Organizations (CROs). Indias growing capabilities in drug development and innovation make it a preferred partner across the value chain

- Growing Regulatory Harmonization: Efforts such as the African Medicines Regulatory Harmonization Program, US- FDAs Project Orbis, and the European Medicines Agencys (EMA) simplified regulatory frameworks are creating more consistent standards across countries. These initiatives are lowering entry barriers for Indian pharmaceutical firms in key global markets.

- Robust Funding: Indias healthcare sector has seen a sharp rise in private equity and venture capital interest. The share of PE/VC investments in healthcare jumped from 6% in 2021 to 17% in the first half of 2024, the highest increase among all sectors-empowering Indian pharma players to expand their global footprint.

- AI / ML and Digitalization: Artificial intelligence and machine learning particularly generative AI, are transforming the pharmaceutical landscape. From R&D and manufacturing to marketing and drug discovery, AI is driving efficiency and innovation. For example, AI is now capable of diagnosing cancer with 96% accuracy and outperforming nurses in critical care tasks, all at significantly lower costs. When combined with traditional AI, generative AI could double its value contribution within 3–5 years.

- Push for Sustainability: With increasing global emphasis on Environmental and Social Governance (ESG), Indian pharmaceutical companies are intensifying their efforts around sustainability. Waste management, carbon emissions reduction, and ESG reporting are becoming critical pillars for maintaining long-term competitiveness in international markets.5

GOVERNMENT INITIATIVES AND POLICY SUPPORT :

The Indian government has been instrumental in shaping a conducive environment that supports the pharmaceutical sectors growth and transformation into a global leader. Building on the foundational Pharma Vision 2020, subsequent policies and schemes have sought to move India from a volume-based producer of affordable medicines to a hub of innovative, high-quality pharmaceutical manufacturing

Pharma Vision 2020 laid out an ambitious roadmap to position India as a global pharmaceutical powerhouse by focusing on affordability, quality, and innovation. This vision has been bolstered by a series of targeted government initiatives aimed at enhancing manufacturing capabilities, boosting exports, encouraging R&D, and improving healthcare access.

- Production-Linked Incentive (PLI) Schemes: To reduce dependency on imports and strengthen domestic manufacturing, especially in critical areas like Active Pharmaceutical Ingredients (APIs) and medical devices, the government introduced PLI schemes. With nearly US$3 billion earmarked for pharmaceuticals and medical devices, these schemes have already attracted close to US$4 billion in investments as of April 2024. In the first half of FY25 alone, the government disbursed ?604 crores (approximately US$69.76 million) under the pharma PLI scheme, reflecting strong momentum in capitalizing on domestic manufacturing potential.

- Promotion of Research and Innovation in Pharma MedTech Sector (PRIP): Launched in 2023, the PRIP scheme marks a strategic pivot from cost-based manufacturing towards innovation-led growth. With an outlay of ?5,000 crore (US$675 million) planned over FY24–FY28, PRIP aims to accelerate the development of New Chemical Entities (NCEs), New Biological Entities (NBEs), complex generics, biosimilars, medical devices and orphan drugs. This initiative is designed to foster cutting-edge R&D and position India as a key player in advanced pharmaceutical technologies.

- Bulk Drug Parks: To address infrastructural bottlenecks and reduce capital and operating costs, the government has sanctioned funds for the creation of bulk drug parks. These parks provide world-class infrastructure, common utilities and

4. Indian Pharmaceutical Industry – Creating Global Impacts– Mar / Apr 2025

5. Indian Pharmaceutical Industry Analysis Presentation – IBEF Feb 2025

compliance, PTUAS offers financial assistance to Small and Medium Enterprises (SMEs) for upgrading their manufacturing facilities. This support helps domestic players meet international standards including WHO Good Manufacturing Practices (GMP), thereby enhancing their global competitiveness.

- Ayushman Bharat Program: Beyond manufacturing, the governments Ayushman Bharat Program including the flagship Pradhan Mantri Jan Arogya Yojana (PMJAY), is expanding healthcare access across India. This program is boosting demand for essential medicines and driving growth in the pharmaceutical market. Additionally, the Ayushman Bharat Digital Mission (ABDM) aims to digitally transform healthcare delivery ensuring interoperability and streamlining patient care, which further supports pharmaceutical supply chain efficiency and demand forecasting.

- Foreign Direct Investment (FDI): India offers an attractive FDI regime to pharmaceutical investors, allowing up to 100% FDI via the automatic route for greenfield projects and up to 74% for brownfield projects (with government approval required for higher stakes). This openness encourages foreign investments, technology transfers and joint ventures, supporting sectoral growth.

- Union Budget 2025-26: The Union Budget for 2025-26 proposes a significant budgetary boost to the pharmaceutical sector. The Department of Pharmaceuticals is allocated Rs. 5,268.72 crores (approximately US$602.90 million), marking a 28.8% increase from the previous fiscal year. This enhanced funding will support infrastructure development, R&D initiatives and regulatory strengthening.

- Regulatory Reforms: The government is actively reforming regulatory frameworks to align Indian pharmaceutical manufacturing and drug approval processes with global standards. Key reforms include the revision of Schedule M to confirm with WHO GMP guidelines, finalizing a comprehensive new drug regulation Act and working towards membership in international regulatory bodies such as PIC/S (Pharmaceutical Inspection Co-operation Scheme) and ICH (International Council for Harmonisation). These reforms aim to improve product quality, streamline approvals and facilitate Indias integration into global pharmaceutical supply chains.

Overall, the governments multifaceted approach - spanning incentives, infrastructure, innovation, regulatory modernization, and healthcare programs - is critical to driving Indias emergence as a global pharmaceutical leader, balancing affordability with innovation and quality.6

CHALLENGES AND OPPORTUNITIES:

Indias pharmaceutical sector stands at the cusp of transformation, with significant opportunities across APIs, generics, biosimilars, vaccines, innovation and contract services. However, to fully unlock its growth potential and become a value-driven global leader, India must address several structural and systemic challenges. These hurdles impact regulatory efficiency, infrastructure, talent, R&D funding and global competitiveness. Simultaneously, each challenge presents an opportunity for reform, investment and long-term capability building.

- Regulatory Hurdles: Indias regulatory landscape is one of the most significant barriers to rapid growth and innovation in the pharmaceutical sector. The approval process for clinical trials remains complex and time-consuming, often delaying product launches and discouraging early-stage innovation. Additionally, India faces delays in granting national marketing approvals after the closure of the Decentralized Procedure (DCP) in the European Union, leading to a lag in global market access. The sector is also governed by multiple regulatory bodies, such as CDSCO, state-level FDAs and other autonomous councils, often leading to coordination issues, inconsistent enforcement and procedural inefficiencies. Streamlining these regulatory frameworks and aligning them with global standards is crucial to enable faster, more predictable approvals and enhance Indias attractiveness as a global pharmaceutical hub.

- Pricing Pressures: While India is known for providing affordable medicines, price control mechanisms such as the Drug Price Control Order (DPCO) create commercial challenges for manufacturers. The DPCO caps prices of essential drugs, limiting profitability, especially in low-margin segments. While this ensures affordability and access for the Indian population, it also disincentivizes investment in product differentiation, complex generics, and innovation. Striking the right balance between price regulation and market-based incentives will be vital in sustaining both affordability and industry competitiveness.

- Intellectual Property (IP) Issues: Indias IP regime has been a longstanding area of contention, particularly in global collaborations and innovation-intensive segments. While India has made strides in patent enforcement, challenges remain, particularly with Section 3(d) of the Indian Patents Act, which limits the patentability of incremental innovations or "improvement patents." This provision, though intended to prevent frivolous patents, may discourage R&D investments in product lifecycle management. Additionally, there is a pressing need to strengthen frameworks for protecting trade secrets, especially in the context of cross-border partnerships and licensing arrangements. Enhancing IP protection mechanisms is essential to attract investment in biosimilars, biologics, novel therapies and co-development models.

6. 2025 Outlook – Economic Times

- Infrastructure Deficiencies: Logistical and infrastructural bottlenecks remain a critical hurdle for the sectors global expansion. India lacks efficient transhipment infrastructure, with approximately 75% of pharmaceutical transhipment cargo routed through foreign ports, adding to time and cost burdens. Furthermore, domestic logistics costs account for 13–14% of GDP, significantly higher than the 8–9% in developed economies. These inefficiencies undermine Indias cost advantage and affect the reliability of pharmaceutical supply chains. Investments in dedicated pharma corridors, cold chain infrastructure, multimodal logistics and port modernization are essential to strengthen export competitiveness and supply chain resilience.

- Talent Development: The pharmaceutical sector is becoming increasingly science and innovation-driven, requiring deep expertise in vaccinology, immunology, molecular biology, and biostatistics. However, India currently faces a talent gap, particularly in basic and translational sciences, regulatory science, and advanced biotechnologies. Closing this gap will require strategic partnerships between academia, industry, and government to revamp curricula, invest in specialized education and skilling programs and foster research ecosystems at national and state levels.

- Funding Gap for R&D: Despite recent initiatives like the PRIP scheme, India continues to lag behind global peers such as the United States and China in R&D investment, particularly in biotech and innovative drug development. Public and private R&D spending remains modest relative to GDP, limiting the pace and depth of innovation. Moreover, early-stage biotech and medtech startups often face hurdles in accessing risk capital, venture funding, and translational research infrastructure. Addressing this funding gap through enhanced government grants, PPP models, biotech incubators and incentives for venture capital will be crucial to nurture a sustainable innovation ecosystem.

While these challenges are significant, they also represent opportunities for transformative change. Regulatory reform can accelerate time-to-market and boost clinical trial activity. Infrastructure upgrades can reduce logistics costs and improve export efficiency. Strengthening IP frameworks can unlock global partnerships and attract high-end R&D. Investing in talent and funding can establish India not just as the "pharmacy of the world," but as a global innovation hub. With the right policy, investment and executional push. India can position itself as a leader in affordable, high-quality and cutting-edge pharmaceutical solutions by 2047.7

Overall Outlook

The Indian pharmaceutical industry stands at a pivotal juncture, poised for transformative growth. Bolstered by robust government support, strategic policy interventions and a rapidly evolving innovation ecosystem. India is well-positioned to move beyond its traditional role as a volume-driven supplier of affordable generics. With increasing investments in R&D, infrastructure, and specialized talent, alongside a clear focus on high-value segments such as biosimilars, specialty generics, vaccines, and innovative therapies, the sector is undergoing a paradigm shift.

Strategic global collaborations, regulatory alignment with international standards, and the development of advanced manufacturing capabilities will be crucial enablers of this transition. By 2047, as India approaches its centenary of independence, the nation aspires to be recognized not just as the "pharmacy of the world," but as the "healthcare custodian of the world",a trusted, innovation-driven leader that delivers high-quality, affordable and impactful healthcare solutions to global populations.

COMPANY OVERVIEW :

Gufic Biosciences Limited ("Gufic") is a distinguished global pharmaceutical Company dedicated to offering a comprehensive portfolio of products and services. With a strong presence across both domestic and international markets, Gufic has established itself as a trusted end-to-end solution provider, supported by a robust distribution network. The Company consistently ranks among the top 100 pharmaceutical companies in India.

A pioneer in lyophilized injections, Gufic operates state-of-the-art automated lyophilization facilities in Navsari, Gujarat, and Indore, Madhya Pradesh. Its diverse product portfolio spans multiple therapeutic segments, including herbal formulations, antibiotics, antifungals, cardiology, infertility, antivirals and Proton Pump Inhibitors (PPIs).

Driven by a strategic vision for global expansion, Gufic continues to strengthen its footprint in key markets such as India, Germany, Switzerland, South Africa, Russia, Canada, Brazil, Europe and other emerging regions. The Company remains committed to its mission of providing affordable, high-quality, life-saving medications to patients worldwide.

In recognition of its progressive workplace culture, Gufic was awarded the title of "Most Preferred Workplace for Women" for FY 2024-25 at an event organized by Team Marksmen Network Private Limited held at The Lalit Hotel, Mumbai, in September 2024.

OPERATIONAL PERFORMANCE AND OUTLOOK:

Criticare Cluster Divisions: Critimax, Mycocare, Primacare & Sparsh

Criticare represents Gufics flagship division, this division caters to Indias critical care injectable market with approximately

?22,000 to ?24,000 Crores addressable opportunity for the current molecule portfolio. The division specializes in life-saving

7. OPPI Annual Summit Report 2023

Market Nuances & Subtle Needs

Hospitals inherently seek seamless dependable solutions that align with stewardship objectives and contain complexity at the bedside whether in preparation, dosing accuracy or drug stability under pressure. Dual-chamber formats, ready-to-administer injectables and clinician education investments speak directly to these operational subtleties.

Market & Therapeutic Focus

Combating Antimicrobial Resistance through Advanced Critical-Care Anti-Infective Solutions:

Antimicrobial Resistance (AMR) is a growing public health crisis in India, with surveillance data showing alarming resistance rates-over 50% in some hospital-acquired pathogens like Klebsiella and Acinetobacter-driven by limited availability of new antimicrobials, inappropriate use, and supply gaps in critical-care anti-infectives.

Advanced injectables play a critical role in enabling hospitals to effectively treat Antimicrobial Resistance (AMR) cases, where timely administration of the right drug, in the right form, can mean the difference between recovery and rapid deterioration. In severe, hospital-acquired infections caused by resistant pathogens, clinicians often rely on last-line and combination therapies that are predominantly available as sterile, lyophilized injectables to ensure stability, potency and rapid bedside preparation. Ready-to-use or ready-to-reconstitute formats further reduce compounding errors, maintain asepsis and allow for optimized dosing strategies such as extended or continuous infusions-vital for drugs with time-dependent killing.

Key molecules in this arsenal include meropenem, ceftazidime-avibactum, colistin and tigecycline, along with newer ?- lactam/?-lactamase inhibitor combinations. Ensuring their uninterrupted availability in advanced delivery formats empowers hospitals to respond swiftly and effectively to AMR-driven critical infections.

Addressing the Immune Dysfunction Gap in Sepsis Management:

Sepsis continues to be a major cause of ICU mortality in India, with outcomes worsened by the dual challenge of high antimicrobial resistance and the immune dysregulation that follows severe infections. Indias ICU landscape sees sepsis in approximately 50-56% of admissions-a stark reality revealed by a 35- ICU point prevalence study (56.4% per Sepsis 3; 27.6% 30 day mortality) - American College of Chest Physicians*

Nationally, sepsis claims roughly 2.9 million lives annually among an estimated 11.3 million cases (CHEST Journal#).

* CHEST Journal 2022 Jun;161(6):1543-1554. doi: 10.1016/j.chest.2021.12.673. Epub 2022 Jan 31.

# Burden of Sepsis in India Jeganathan, Niranjan CHEST, Volume 161, Issue 6, 1438 - 1439

While antibiotics remain essential, they do not address the underlying immune dysfunction-leaving a clear market gap for therapies that can modulate and restore immune competence. There is a pressing need for interventions that can enhance immune responsiveness, promote faster pathogen clearance, and reduce secondary infections in critically ill patients.

Our immunomodulatory therapy approved by the DCGI for sepsis directly targets this gap by rebalancing the host immune response, aiding recovery in patients where conventional antimicrobial treatment alone is insufficient and offering hospitals a valuable adjunct in the fight against sepsis-related mortality.

Gufics Criticare portfolio is purpose-built around these priorities: suite of complex sterile injectables including advanced ?- lactam/?-lactamase inhibitors, next-generation echinocandins and first-to-market immunomodulator for sepsis; dual-chamber and ready-to-administer technologies to simplify critical care workflow; and sustained clinician engagement through sepsis and AMR scientific programs. This approach supports both hospital process integrity and improved clinical confidence.

Sparsh is built as a comprehensive hospital platform: a wide, up-to-date portfolio spanning routine to specialized injectables; Ready to administer/dual-chamber technologies to simplify bedside use; and lyophilization/aseptic know- how to safeguard stability and potency. Operationally, Sparsh offers hospitals single-window access to high-quality SKUs with disciplined pricing and supply resilience-supported by ongoing formulary collaborations, pharmacy education, and continuous stability work to keep instructions, infusion rates, and excessive use guidance unambiguous and current. In short, Sparsh pairs quality-first manufacturing with procurement-friendly economics, helping institutions standardize practice while protecting budgets.

Ferticare Cluster Divisions: Ferticare & Fertimax

Ferticare addresses Indias substantial infertility challenge, targeting the ?4500 crores fertility treatment market serving 15-20 million couples struggling with infertility. The division specializes in assisted reproductive technologies (ART), hormonal therapies, IVF support medications and reproductive health solutions across ART service providers – corporate chains and individual practitioners.

Market Gap & Therapeutic Focus

Indias fertility care is scaling on the back of later parenthood, improved access and formalization under the ART Act (2021). Estimates peg the India IVF market at ~ 300,000 cycles p.a with a projected early teen CAGR through 2030, reflecting steady, structural demand rather than episodic spikes. Regulatory tightening is improving transparency while costs remain largely out-of-pocket, shaping case-mix and provider economics.

Clinically, two cohorts concentrate unmet need: low-prognosis/poor responders and recurrent implantation failure (RIF). In these cases, POSEIDON* emphasizes individualized prognosis and oocyte yield targets; it helps clinicians tailor stimulation intensity and adjunct choices. RIF-failure of implantation despite transfer of good-quality embryos-affects roughly

~10% of IVF couples and reflects multi-factor biology (embryo competence, endometrial receptivity, immune/endocrine milieu).

* POSEIDON refers to the POSEIDON criteria - a classification system for identifying and stratifying women with a low prognosis in IVF/ICSI treatment. POSEIDON Group is an international panel of reproductive medicine experts.

Market Nuances & Subtle Needs:

High-Purity Gonadotrophins - Closing a Critical Quality Gap in ART:

As ART protocols in India move toward greater standardisation, cycle outcomes are increasingly dependent on the precision, purity, and consistency of gonadotrophins. The current market has a clear gap-many available products do not match the purity profile, bioactivity consistency, or reliability of innovator brands, affecting clinician confidence and patient outcomes. Fertility centres seek gonadotrophins with tightly controlled bioactivity (IU), high purity, predictable trigger/luteal performance and robust cold-chain stability that can perform equally well in both metro and Tier-2/3 settings.

Purchasing decisions are shaped more by product reliability, availability, and clinician trust than by molecule branding. Gufics focus on stringent manufacturing controls, advanced purification processes and targeted clinician trust building directly addresses this market gap-positioning the company as a trusted partner in delivering high-quality gonadotrophins that optimise ART outcomes.

Immune Therapy in Recurrent Implantation Failure: Targeted Approach for Better Outcomes:

Recurrent Implantation Failure (RIF) is often linked not only to embryo quality or endometrial receptivity but also to an underlying imbalance in the maternal immune response-where excessive immune activation or inadequate tolerance impedes successful implantation.

Gufics Immune-modulating therapy for RIF restores this balance work by enhancing T-cell regulation, promoting Natural Killer (NK) cell modulation and improving cytokine profiles to create a more receptive endometrial environment. Gufic has advanced

By selecting the right cohort-those with immunological profiles predictive of a positive response-this targeted strategy improves implantation success rates, reduces unnecessary exposure to therapy and enhances clinician confidence in treatment planning. This precision-driven model strengthens both clinical outcomes and trust in immune-based interventions for RIF.

Ferticare Cluster is oriented to these practicalities, an emphasis on high-purity gonadotropins designed for precise titration; portfolio breadth across stimulation, trigger and support to simplify clinic protocols; lyophilization and cold-chain discipline to safeguard stability; and evidence-building with Indian KOLs in low-prognosis/RIF contexts as the science evolves. Structured center engagement-scientific engagements, protocol formulation, and multicenter evaluations-aims to translate clinical nuance into everyday reproducibility, lifting outcomes without adding complexity.

Toxin Segment Divisions: Aestherderm & Neurocare Market & Therapeutic Focus

Indias toxin market straddles two distinct but complementary spheres:

- Aesthetics: Rising self-care consciousness, "age-freezing" aspirations, and growing disposable incomes are gradually shifting the demand curve. While Indias median age is ~29, in mature Western markets, first-time botulinum toxin use often begins around 30-35 years of age. In India, younger consumers are still forming perceptions-category creation here requires sustained education, visibility and trust-building.

- Neurology: Therapeutic toxin use for conditions such as chronic migraine, spasticity, dystonia, and urology indications is anchored in specialist clinics. These are smaller, high-acuity patient pools where under-penetration is common, but clinical outcomes drive loyalty once adoption occurs.

Market Nuances & Adoption Dynamics

Both segments share a slow initial adoption curve but exhibit high retention and loyalty once patients or consumers see sustained benefit. For aesthetics, the social normalization of preventive or corrective procedures is still emerging-making trusted clinicians and portfolio breadth critical to product penetration. For neurology, specialist familiarity, clear local evidence, and hands-on technique confidence are essential to build comfort with toxin protocols.

Gufics Solutions & Strategic Positioning

Gufics toxin strategy unites portfolio completeness with ecosystem development:

- Aesthetic arm expanding beyond botulinum toxin into antioxidant therapies, dermal fillers, and stimulators- enabling clinicians to manage the full spectrum of age-management and facial harmonization needs for their cohort.

- Neurology arm driving category penetration through scientific initiatives-local observational studies, structured hands-on training workshops, and continuing medical education targeted at headache, spasticity, and dystonia specialists.

- Cross-segment focus on quality, accessibility, and training to build clinician confidence and patient trust.

By coupling portfolio expansion with sustained category-building in both consumer and clinical segments, Gufic is positioned to shape long-term toxin adoption in India-transforming early-stage interest into durable, recurring demand.

Mass Market Specialities:

Nutraceuticals & Herbal Wellness Division: Healthcare

Built around our Sallaki? (Boswellia serrata) platform, this division brings together joint care (Sallaki range, Nucart- OA/VG), bone health (Bocomo Forte with Cissus), uro-stone prevention (Smashit), and recovery & resilience (Imunocin, Aswal Plus), supported by topical pain relievers (liniment/gel). The portfolio is designed as protocolised adjuncts for orthopedics, rheumatology, urology and primary care-covering acute flare, maintenance, and prevention.

What differentiates us:

- End-to-end integration: Our in-house extraction facility and dedicated nutra/herbal manufacturing give full control of sourcing, standardisation (e.g., AKBA-standardised Boswellia), and contamination limits, ensuring batch-to- batch consistency and reliable clinical experience.

- Evidence-led formulations: Vegetarian/shellfish-free options (Nucart-VG), NSAID-sparing joint regimens (Sallaki + Nucart), multi-target stone prophylaxis (Smashit), and bone support beyond plain calcium (Bocomo Forte with Cissus).

- Care pathways, not pills: Ready-to-use clinic protocols (systemic + topical bundles, fracture-healing and recurrence- prevention kits) with simple patient education and adherence tools.

Market gaps we address:

- Quality variability in herbals: We close the gap with standardised actives, CoAs, and rigorous heavy-metal/pesticide testing.

- Limited vegetarian choices in joint care: Nucart-VG serves ethical/vegetarian and shellfish-allergic patients without compromise.

- Overreliance on NSAIDs for chronic OA: Sallaki-centric regimens enable longer-term, gut-safer adjunctive management.

- Poor protocolisation and adherence: Our bundled kits and guidance help clinicians deliver consistent outcomes.

- Underserved prevention segments: Stone-recurrence and bone-strengthening programs extend care beyond symptom relief.

This integrated model positions us to scale a trusted, science-forward nutraceutical franchise with defensible quality, clinician confidence, and patient-friendly outcomes.

Womens Health & Ortho-Gynac:

Division: Zenova

Zenova is built to be the partner of choice for OB/Gyn OPD practices running IUI programs and for clinics at the womens health–mobility concerns. Our focus is on reliability at cycle-deciding moments, patient-friendly formats, and protocolised care pathways rather than molecule novelty.

Market & therapeutic focus:

- IUI pathways in OB/Gyn OPDs: Products and clinic tools that support the critical points of an IUI cycle-ovulation trigger and luteal support-delivered with validated potency and last-mile cold-chain integrity to reduce cycle variability.

- Pregnancy anticoagulation when prescribed: A prefilled safety-device pen presentation of enoxaparin that enables confident initiation and self-use under clinician guidance.

- Womens mobility & recovery in clinic: Joint-nerve support and analgesia for peri-/post-partum and peri-menopausal patients, reflecting the everyday case-mix OB/Gyns see alongside reproductive care.

- Skin integrity in pregnancy: Stretch Nil establishes a clinician-led category as the only pregnancy-dedicated stretch-mark solution in the prescription channel, enabling OB/Gyns to guide prevention and early care.

What gaps we address:

1. Cycle-critical reliability: Fragmented supply and handling can jeopardise IUI outcomes. We compete on assured availability, potency-linked release, and documented cold-chain to the pharmacy level.

2. Protocol & adherence at the point of care: Calendarised packs, clear dosage cards and prefilled safety devices translate guidelines into simple, repeatable clinic workflows.

3. Integrated womens care under one roof: OB/Gyn clinics often manage pain, mobility and recovery needs; our portfolio and care kits allow a single-stop pathway from cycle support to convalescence.

4. Credible, OB-led skincare in pregnancy: Stretch Nil fills a long-standing gap with a pregnancy-specific, Rx-grade option backed by clinician counselling.

International Business – Strategic Growth Roadmap Market Potential & Portfolio Leverage

With a strong base of regulated market dossiers already developed, Gufic is well-positioned to accelerate entry into select international geographies. These dossiers provide a ready platform to participate in high-value, compliance-driven markets, ensuring faster speed-to-market. Over the medium term, the portfolio will be broadened with new products from the Indore facility, where dossier approvals and tailored launch strategies will be aligned with local market dynamics. Multiple go-to- market models including direct partnerships, licensing, and tender participation-enable us to customize engagement by molecule and geography, strengthening relevance and competitive positioning.

Roadmap (3–5 Years)

Our goal is to capture 5-10% share in targeted geographies by scaling across both current and upcoming molecules. The EU-GMP certified Unit II at Navsari forms the backbone of current production, with exports already gaining traction. The next phase of growth hinges on the scale-up at the Indore facility, which will de-bottleneck Navsari, unlock capacity for new products, and ensure alignment of manufacturing with portfolio expansion. Tech transfers to Indore and selective domestic CMO outsourcing will further free up Navsari capacity exclusively for regulated exports.

This strategic shift is already translating into measurable wins. A prestigious UK NHS tender has been secured, with supplies from Navsari commencing in FY25–26. This milestone validates Gufics quality, reliability, and execution capability in highly regulated settings. With capacity now opening at Navsari, export volumes are scaling steadily, providing the operating leverage to fuel growth. These early successes lay a strong foundation for long-term expansion in international markets, reinforcing confidence in our ability to execute and scale.

Research & Development:

Our R & D approach continues to be guided by three pillars: leveraging our world-class lyophilisation capabilities, building a pipeline of differentiated complex injectables and pursuing partnerships and in-licensing to expand our therapeutic reach.

1. Focus on Complex and Niche Injectables

• The Company has deliberately built a portfolio concentrated on complex injectable formats-including liposomal formulations, long-acting microspheres, suspension-based injectables, ready-to-use (RTU) solutions and high potency molecules.

• By focusing on products that require advanced technology platforms (e.g., lyophilisation, microspheres, depot injections, lipid-based drug delivery), we are differentiating from commoditised injectables and positioning ourselves for sustainable growth in global markets.

2. Leadership in Lyophilisation

• With one of the largest lyophilisation capacities in the region, we are uniquely placed to serve high-value segments where stability, extended shelf life and sterility assurance are critical.

• This capability allows us to pursue opportunities in anti-infectives, antifungals, critical-care injectables and oncology/biologics, where lyophilisation is often the gold standard.

3. Diversified Therapeutic Coverage

• The R&D pipeline spans critical care, anti-infectives, pain management, CNS, cardiovascular, metabolic disorders, and oncology, ensuring both therapeutic diversification and risk balance.

• Several pipeline candidates address unmet needs in hospital-based acute care settings, further enhancing the relevance of our portfolio to physicians and healthcare systems.

4. Technology Platforms Driving Innovation

• Beyond lyophilisation, the company is building strong competencies in liposomal drug delivery, microsphere based sustained release, emulsions, and suspensions.

• These technology platforms create barriers to entry and enable the development of products that are not easily replicable by generic peers.

5. Balanced Portfolio Strategy

• The pipeline reflects a mix of high-volume hospital injectables (to ensure baseline business stability) and niche, limited competition molecules (to drive margin expansion).

• This dual-track approach allows us to capture both scale-driven opportunities and value-driven opportunities in regulated and emerging markets.

6. In-Licensing and Global Partnerships

• Selective in-licensing is being pursued to complement internal development in areas requiring advanced know-how or market access synergies.

• Such collaborations expand our reach into specialty and innovative products while reducing development timelines.

Looking Ahead

While we continue to deepen our investments and progress within our core focus areas of complex and differentiated injectables, we are also strategically expanding our horizons. Our R&D pipeline now includes biosimilars in the recombinant ormone space, aimed at addressing critical therapeutic gaps with high-quality, affordable solutions. In parallel, we are advancing novel, first-of-their-kind innovations in the fields of toxins and oral vaccines, reflecting our commitment to pioneering therapies that redefine standards of care. This balanced approach ensures that we remain firmly anchored in our strengths while opening new frontiers of growth and innovation.

FINANCIAL PERFORMANCE:

In the financial year 2024-25, the Company reported revenue from operations of INR 81,980.60 lakhs, as against INR 80,666.57 lakhs in 2023-24. EBITDA stood at INR 14,001.90 lakhs compared to INR 14,947.78 lakhs in the previous year.

The domestic market contributed 79.83% of the Companys turnover, while exports accounted for 20.17%, as against 10.93% in the previous year. The Company will continue to strengthen its focus on expanding export revenues.

Net Profit for the current financial year was INR 6,993.28 lakhs, compared to INR 8,613.55 lakhs in 2023-24.

The consolidated financial statements include the results of Gufic UK Limited (Wholly Owned Subsidiary in the United Kingdom), Veira Life FZE (Wholly Owned Subsidiary in Dubai), and Gufic Prime Private Limited (Subsidiary in India). As these subsidiaries did not undertake business operations during FY 2024-25, the revenue and profit figures are consistent across standalone and consolidated financials.

Overall, FY 2024-25 was marked by steady performance, reflecting progress in strategic objectives. The Company remains committed to delivering innovative, high-quality healthcare solutions while creating long-term value for its stakeholders.

KEY FINANCIAL INDICATORS:

PARTICULARS	Unit	2024-25	2023-24	Variance (%)	Reasons if variance is more than 25%
Operating profit margin (%)	%	14.51	16.42	-11.64	-
Net profit margin (%)	%	8.53	10.68	-20.11	-
Debtors turnover ratio	Times	2.54	3.01	-15.58	-
Current ratio	Times	1.61	1.61	NIL	-
Return on Net Worth	%	11.63	16.17	-28.10	Return on Net Worth decreased on account of decrease in Profit.
Inventory turnover ratio	Times	3.57	4.01	-10.89	-
Interest coverage ratio	Times	5.71	8.90	-35.86	Interest coverage ratio decreased due to increase in Finance Cost, monthly repayment of Term Loan & decrease in profit.
Debt Equity Ratio	Times	0.52	0.60	-13.30%	-

INTERNAL CONTROL FRAMEWORK:

At Gufic, we recognize that a robust internal control system is fundamental to sound governance. We are committed to executing our business strategies within a framework that emphasizes checks and balances. Our company has developed a comprehensive internal control framework to continually assess the adequacy, effectiveness, and efficiency of our financial and operational controls. We are dedicated to fostering an effective internal control environment that reflects the scale and complexity of our operations, ensuring adherence to internal policies, relevant laws and regulations, and safeguarding our resources and assets.

The Company has in place SAP software which enhances our ability to manage and monitor these controls more effectively. Additionally, we have an in-house internal audit team, led by a Chief Internal Auditor, that plays a crucial role in this framework. The Audit Committee of the Company reviews the internal audit reports on a quarterly basis. Based on these reports, corrective actions are undertaken as necessary and controls are continuously strengthened. During the year under review, no material or serious observations have been reported by the internal auditors regarding inefficiencies or inadequacies in our controls.

Furthermore, our Company adheres to all applicable Indian Accounting Standards to ensure accurate maintenance of our books of accounts and the reliable reporting of our financial statements.

At Gufic, our people are at the heart of everything we do. As of March 31, 2025, we were proud to have a dynamic and diverse team of 1,988 employees who continue to be the cornerstone of our success. We remain committed to providing a secure, inclusive and sustainable workplace, strengthened by eco-friendly initiatives and stringent industrial hygiene standards that safeguard employee health and well-being. Guided by a strict code of conduct and a zero-tolerance policy against discrimination or harassment, we strive to uphold fairness, integrity, and respect across the organisation.

To keep the workplace vibrant and collaborative, we place strong emphasis on employee engagement. Our "Together Team", formed by employees from different departments on a rotational basis, actively organises creative events throughout the year. These efforts are complemented by an annual week of fun-filled activities, culminating in our Annual Day celebration, which further strengthens camaraderie and team spirit.

Recognising the efforts and contributions of our employees remains central to our people practices. We run structured programs such as:

• Employee of the Month Awards, appreciating outstanding performance.

• Long Service Awards, celebrating employee loyalty at milestones of 5, 10, 15, 20, and 25 years.

Our commitment to building an empowering workplace has also been acknowledged externally. In FY 2024-25, Gufic was honoured as the "Most Preferred Workplace for Women", at an event hosted by Team Marksmen Network Private Limited at The Lalit Hotel, Mumbai.

We continue to invest in the professional development and welfare of our employees through a wide range of initiatives, including:

• Comprehensive Medical Insurance covering all employees.

• Grievance & Suggestion Mechanisms for transparent feedback and resolution.

• Training Programs and Seminars to enhance technical and leadership skills.

• Sponsorship for Higher Education, encouraging continuous learning.

• Internal Complaints Committee, constituted under The Sexual Harassment of Women at Workplace (Prevention, Prohibition and Redressal) Act, 2013, ensuring a safe and respectful workplace.

Additionally, our Whistleblower Policy, monitored by the Board of Directors, empowers employees and directors to report unethical behaviour, fraud, or policy violations without fear of retaliation. Full details of this policy are available on the Companys website.

At Gufic, teamwork, excellence, and integrity define our work culture. The dedication of our people has been pivotal in driving the Companys progress, and we remain committed to nurturing a workplace that fosters growth, innovation, and collaboration. Importantly, there were no significant changes in Human Resources or Industrial Relations during FY 2024-25, underscoring the stability and strength of our people practices.

Our employees remain central to Gufics vision of delivering healthcare excellence and their collective passion and commitment continue to propel the Company towards greater achievements.

THREATS, RISKS & CONCERNS

Risk management is integral to the Companys operations. Gufic proactively addresses risks in a structured and organized manner. The Company has established a comprehensive risk management policy, which is periodically reviewed and updated by the Board of Directors. While it is not possible to entirely eliminate the risks inherent in the business, they can be effectively mitigated through precautionary measures.

Risk Type	Risk	Mitigation Measures
Business Risk	Concentration Risk	Remain diversified across products and geographies.
	Competition Risk	Focus on product quality, timely supplies and industrial practices.
	Price Risk	Work on cost control and improved yields.
	International Operations Risk	Hedge risks through third parties and avoid high-risk countries.
	Insurance	Maintain various insurance covers for property and human resources.
	Human Capital Risk	Enhance employee well-being and development through talent management.
Financial Risk	Credit Risk	Follow SOPs for credit approval processes.
	Treasury/Foreign Exchange Risk	Monitor the forex market regularly and hedge risks.
	Liquidity Risk	Maintain flexible funding and monitor cash flows.
External Risk	Legal Risk	Regular reviews of contracts, insurance audits and compliance monitoring.
	Cyber security and Data Privacy Risks	Install IT security systems, train employees and regularly review practices.
	Market Risks	Diversify suppliers and conduct periodic audits.
	Intellectual Property Risk	Ensure due diligence in agreements and include IP terms with third parties.

CAUTIONARY STATEMENT

Certain statements in the MDA section concerning future prospects, Companys objectives, projections, estimates, expectations, plans or industry conditions or events may be forward-looking statements which involve a number of underlying identified / non identified risks and uncertainties that could cause actual results to differ materially from those expressed or implied. Important factors that could make a difference to the Companys operations include global and Indian demand-supply conditions, finished goods prices, feedstock availability and prices, competitors pricing in the Companys principal markets, changes in government regulations and policies, tax regimes, economic conditions within India and the countries within which the Company conducts business and other factors, such as litigation and labour unrest or other difficulties. These forward- looking statements represent only the Companys current intentions, beliefs or expectations and any forward-looking statement speaks only as of the date on which it was made. The Company assumes no obligation to revise or update any forward-looking statements, whether as a result of new information, future events, subsequent development or otherwise except as required by applicable law.