Santhanakrishnan Srinivasan Ph.D, MBA

The Biosecure Act’s journey has hit a roadblock with its exclusion from a key defense spending bill . This suggests the Act will now fall under the purview of the incoming Trump administration. Does this delay still present an opportunity for Indian CDMO players? I believe it absolutely does.The global drive to de-risk supply chains for innovators remains critical, and India, with its proven manufacturing ecosystem, is uniquely positioned to lead this transformation.While short-term uncertainties may linger, the incoming administration is likely to prioritize efforts to strengthen global supply chains . Sustainability and predictability in this industry is essential to safeguarding public health. For Indian pharma players, this is the time to continue to shift direction . With over 5,00 generic API manufacturers, 1,000 finished product companies . The increasing investments in biotech, specialty chemicals & agrochemicals, India stands at the cusp of this industry evolution.While many Indian firms already operate as CMOs for drug substances / products, much of this activity falls short of the comprehensive definition of CDMO or CRDMO services from an external perspective. This is not just an opportunity—it is a strategic necessity. Success in the CDMO space is a marathon, not a sprint. Good Times Ahead !!! #pharmaceuticals #cdmoindia.com #smallmolecules #biologicals #Lifescience

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😶 #Indian-manufactured #drugs have seen a surge in popularity among #American #patients, driven by the combination of affordability and quality. Indian export to USA is therefore increasing. In an effort at using the regulatory system to fight competition from Indian pharma companies, eight Indian pharma companies are amongst the 11 global companies that have been served with “#Form483” of United States Food and Drug Administration (USFDA) since the start of 2024. The companies are Cipla Limited (three times), Torrent Pharmaceuticals Limited (once), Dr. Reddy’s Laboratories Ltd CTO Unit 6 (once), Laurus Synthesis Pvt Ltd (once), Eugia Pharma (four times), Zydus Lifesciences Ltd (two times), Alkem Laboratories Limited and Jubilant Generics (both once). The remaining three companies are located in Japan, Iceland and China. #BigPharma is very influential in any US administration, which is why pharma prices in the US are often a hundred or more times more than equivalents produced by Indian companies and are trying to block Indian competition through FDA: https://lnkd.in/dHke7F_e

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Is Suven Pharmaceuticals’s bold move into the ADC sector with NJ Bio the game-changer for its future growth? Vivek Sharma reveals the strategy behind this acquisition. Watch the full interview here: https://lnkd.in/ddywkxsV Ayesha Faridi Vengsarkar Avanne Dubash Times Network 

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This article and maybe the newspaper is bullshit. In simple words. It is so wrong how wrong any information only could be. The style of language and the given message to the readers is the worst that you can choose - it is simply bad. It has nothing to do with ethics, knowledge or any code of journalism. Most probably this is a result of total stupidity on several levels or populistic hate-speech in Goebbels style. In any case, such intolerance should not answered with tolerance - therefore - naming it bullshit is acceptable.

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Introduction to Indian Pharma Entrepreneurs: Number 3 - Shri Ramesh & Rajeev Juneja founders of MANKIND PHARMA LTD 🌟 Meet Ramesh Juneja, the visionary founder of Mankind Pharma, a company that has redefined the pharmaceutical industry with its patient-centric approach and affordable healthcare solutions. From its inception in 1995, Mankind Pharma has grown under his dynamic leadership to become one of India’s leading pharmaceutical companies, renowned for making high-quality medicines accessible to millions. With a focus on innovation, affordability, and inclusivity, Mr. Juneja has not only built a successful business but also contributed significantly to improving lives across the globe. Hailing from Meerut in Uttar Pradesh, the brothers embarked on this entrepreneurial journey with a modest capital of Rs 50 lakh and a small team of 20 employees. Their initial operations were limited to just two states, but their vision and dedication quickly propelled the company to national prominence. Mankind Pharma's success is further demonstrated by its recent accomplishments and calculated actions: Initial Public Offering (IPO): A major turning point in Mankind Pharma's history was reached in April 2023 when the company went public. The company's market position has been further cemented by the IPO, which has also generated a lot of interest from investors. Purchase of Bharat Serums and Vaccines: Mankind Pharma would pay about Rs 13,630 crore to purchase Bharat Serums and Vaccines from Advent International in a significant strategic move. It is anticipated that this acquisition would expand Mankind's product line and market penetration. Investment from Private Equity Firms: Capital International and ChrysCapital are two significant private equity firms that have invested in the company. These investments are well-positioned to help humanity's ongoing growth and development. Mankind had revenue of Rs 8,749 crore and profit of Rs 1,310 crore in FY23. Domestic revenue accounted for 97% of the total. For FY24, revenue rose to Rs 10,335 crores and net profit increased to Rs 1,942 crore. The company had a net cash balance of Rs 3,260 crore as on March 31, 2024. The company has for the last five years been ranked number one in the number of prescriptions. His entrepreneurial journey is a testament to the power of vision, perseverance, and a mission-driven approach. 🌐💊

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The potential of 3rd party manufacturing in India India's pharmaceutical industry is on the cusp of a transformative journey, poised to make a significant impact on the global stage. With its rich legacy of pharmaceutical manufacturing, India has established itself as a hub for high-quality, cost-effective drug production. As the industry continues to evolve, third-party manufacturing is emerging as a key driver of growth, innovation, and collaboration. By embracing this model, Indian pharmaceutical companies can tap into a wealth of benefits, from enhanced capacity and capabilities to access to specialized expertise and global markets. As the demand for pharmaceuticals continues to rise, driven by an aging population, increasing healthcare needs, and the emergence of new therapies, India's third-party manufacturing sector is well-positioned to meet this growing demand. With its robust infrastructure, skilled workforce, and favorable regulatory environment, India offers a compelling proposition for global pharmaceutical companies seeking reliable, high-quality manufacturing partners. In this context, the potential of third-party manufacturing in India is vast and varied, encompassing: 1. Cost competitiveness: India offers a cost-effective manufacturing base, making it an attractive option for global pharma companies. 2. Skilled workforce: India has a large pool of skilled professionals, including scientists, engineers, and technicians. 3. Regulatory framework: India's regulatory environment is improving, with initiatives like the "Make in India" campaign, encouraging foreign investment. 4. Export opportunities: India's strategic location allows for easy access to markets in Asia, Africa, and the Middle East. 5. Innovation hub: India is home to a growing number of research and development (R&D) centers, fostering innovation and new product development. 6. Government support: Initiatives like the "Pharma Vision 2020" aim to promote India as a global pharmaceutical hub. 7. Capacity expansion: Third-party manufacturing can help Indian pharma companies expand capacity and meet growing demand. 8. Specialized services: India offers specialized services like contract research, formulation development, and packaging. 9. Global partnerships: Indian companies can form partnerships with global pharma companies, enhancing their capabilities and reach. 10. Job creation: The growth of third-party manufacturing in India can lead to significant job creation and economic growth. By harnessing these advantages, India's third-party manufacturing sector can drive growth, innovation, and employment, cementing the country's position as a leading player in the global pharmaceutical industry. Torainse Lifecare Pvt Ltd Chandigarh  Contact - 8427555559  Karanbir Singh  Managing Director https://lnkd.in/gYfnqHYC

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#Y2KMoment #CDMOindia As the Bio-Secure Act takes centre stage, there is a growing buzz across both affected and beneficiary countries. The big question on everyone's mind in Indian industry: Should we invest now in new technology, infrastructure, R&D, and market reach, or should we wait? Interestingly, this moment reminds me of the Y2K scenario for the Indian IT industry. Back in the late 1990s, the world braced for a potential digital crisis as we approached December 31, 1999. Indian IT firms seized the opportunity, working hard to establish themselves as global leaders. While larger companies initially had the edge, it was the mid and smaller, more agile, and transparent firms that have since become into today's industry giants. So, are there parallels for the Indian CDMO industry today? I believe so..... A ) Y2K had a clear deadline, and so does the Bio-Secure Act. US innovators have a 5-year window to realign and shift supply chains for commercial projects. Of course new molecules will find their homes from day one, which means an immediate inflow of RFPs and due diligence of the service providers. B ) For the Indian CDMO sector, now is the time to act. Building technical capabilities and scaling efficiently should be our focus. Let us not forget—during the Y2K frenzy, poor execution, overpromising, and greed wiped out many IT companies. We must avoid those pitfalls. C ) The IT industry’s success hinged on human capital and brilliant minds. The best HR practices played a crucial role during the Y2K period and beyond. The same applies now to the CDMO industry—talent and leadership will be pivotal in this knowledge based industry as well . This is not just a one-time event; it is a journey. If we handle it right, this could reshape the industry for years to come. We had other countries at that time looking for IT business as our competitors ! And we have the same situation for CDMO today . India prevailed and will do the same this time as well ! The key ! Shift business models, deploy resources with long-term vision, execute responsibly, and deliver consistently. The future is massive !!!

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As 15 Blockbuster drugs whose revenue worth of USD 112 Billion will go Off patent in next 5 years, Indian pharma industry is having a growth opportunity of USD 10 Billion. Exports are expected to reach $ 55 Billion by 2030 Drugs going to be Off patented soon KEYTRUDA—Merck ELUQUIS — BMS & PFIZER EYELIA — Bayer OPIVIDO — BMS & PFIZER IBRANCE —Pfizer XARELTO —Bayer TRULICITY — Elililly PRENVER-13 — GSK OCREVUS — Roche PROLIA/XGEVA —Amgen ESBRIET — Roche OPSUMIT —Actelion ENTRESTO — Novartis FARXGIA —Astra Zeneca XELJANZ — Pfizer #Indianpharma #offpatent #Generics #Biosimilars Indian Pharmaceutical Alliance Indian Drug Manufacturers' Association Department Of Pharmaceuticals https://lnkd.in/gStZ7hyg

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In the life sciences domain, software validation often becomes the biggest hurdle in the journey toward digitisation. While validation is a non-negotiable requirement, companies are constantly looking for scalable solutions to minimise revalidation efforts, especially when faced with the dynamic needs of business processes and regulatory changes. But here’s the catch: Many solution providers promise scalability during product evaluations. Unfortunately, this often refers only to technical scalability—handling more users or larger data volumes—and not functional scalability, which is about adapting to evolving business needs, regulatory updates, or CAPA-driven changes without repetitive validation efforts. Without functional scalability, even small changes can lead to complete revalidation, causing delays, escalating costs, and unnecessary effort. 𝟓 𝐒𝐞𝐜𝐫𝐞𝐭𝐬 𝐭𝐨 𝐀𝐜𝐡𝐢𝐞𝐯𝐢𝐧𝐠 𝐅𝐮𝐧𝐜𝐭𝐢𝐨𝐧𝐚𝐥 𝐒𝐜𝐚𝐥𝐚𝐛𝐢𝐥𝐢𝐭𝐲 Here’s how to ensure your systems evolve with minimal revalidation efforts: 𝟭. 𝗘𝗺𝗯𝗲𝗱𝗱𝗲𝗱 𝗪𝗼𝗿𝗸𝗳𝗹𝗼𝘄 𝗮𝗻𝗱 𝗔𝘁𝘁𝗿𝗶𝗯𝘂𝘁𝗲 𝗠𝗮𝗻𝗮𝗴𝗲𝗺𝗲𝗻𝘁 Your system should support dynamic approval hierarchies and evolving compliance roles. Additionally, metadata configuration must be seamless to keep pace with organizational growth and regulatory demands. 𝟮. 𝗣𝗿𝗲-𝗖𝗼𝗻𝗳𝗶𝗴𝘂𝗿𝗲𝗱 𝗠𝗮𝗿𝗸𝗲𝘁 𝗙𝗶𝘁 𝘄𝗶𝘁𝗵 𝗙𝗹𝗲𝘅𝗶𝗯𝗶𝗹𝗶𝘁𝘆 A system pre-configured with industry best practices is essential but must also allow configuration to cater to specific organizational needs. This ensures you can validate the variable configurations rather than revalidating the entire system. 𝟯. 𝗙𝗿𝗼𝗻𝘁-𝗘𝗻𝗱 𝗖𝗼𝗻𝗳𝗶𝗴𝘂𝗿𝗮𝘁𝗶𝗼𝗻 𝗠𝗮𝗻𝗮𝗴𝗲𝗺𝗲𝗻𝘁 Mature systems with robust front-end configuration tools reduce revalidation efforts. These allow you to validate specific functionalities rather than revalidating workflows for every change. 𝟰. 𝗣𝗿𝗲-𝗗𝗲𝘃𝗲𝗹𝗼𝗽𝗲𝗱 𝗔𝗣𝗜𝘀 Seamless data exchange between systems is the backbone of digital transformation. Look for service providers offering pre-developed APIs that integrate various systems effortlessly, saving both time and effort. 𝟱. 𝗗𝘆𝗻𝗮𝗺𝗶𝗰 𝗗𝗮𝘁𝗮𝗯𝗮𝘀𝗲 𝗮𝗻𝗱 𝗔𝘂𝗱𝗶𝘁 𝗧𝗿𝗮𝗶𝗹 While allowing configuration, your system’s architecture must ensure scalability in the database structure and audit trail scope to support compliance and growth effectively. 𝐖𝐡𝐲 𝐈𝐭 𝐌𝐚𝐭𝐭𝐞𝐫𝐬 Balancing scalability with agility is vital for sustainable digital transformation in pharmaceutical and biotech industries. Let’s focus on solutions that enable growth, compliance, and adaptability—without stretching budgets or timelines. Digitize smartly. Choose scalability that works for you! #LifeSciences #Validation #Scalability #DigitalTransformation #srutasolutions #CAPA #pharmaceuticals #softsign

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Start Your Own Profitable Industry “The Industry Success Formula“ A Blueprint for Success: Starting and Scaling a Micro and Small Scale Industry in India https://lnkd.in/gWXKe-_n

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MANKIND PHARMA LTD Pharma is set to acquire Bharat Serums and Vaccines Limited (BSV) from Advent International for approximately Rs 13,630 crore. Here’s what you need to know: 🎯 Strategic Acquisition: This move positions Mankind Pharma as a leader in the Indian women's health and fertility drug market. 💊 Portfolio Expansion: The acquisition includes high-entry barrier products in critical care, backed by advanced R&D technology platforms. 👨‍⚕️ Enhanced R&D Capabilities: BSV’s research teams will significantly bolster Mankind Pharma's existing R&D efforts. 💉 Biologics Boost: This acquisition will provide a significant boost to Mankind Pharma's biologics plans, enhancing their capabilities in this advanced field. 🌎 Global Reach: BSV’s operations span over 70 countries, with subsidiaries in Germany, the Philippines, and the US, further strengthening Mankind Pharma's international footprint. MANKIND PHARMA LTD - Sheetal Arora

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When an apple turns into a brinjal, the CEO wonders what happened. The world is adept at changing 'what is' to ' what I hear' to 'what I say' & 'what I see'. The least one can do is not to jump to 'what' without understanding and explaining the 'why'. Keep the content in communication clear & concise, yet complete. If the essence is lost, the impact is lost. Guided random inquiry across hierarchy can avoid chinese whispers.

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No, You are NOT prepared for this❗️❗️ 👇 ❗️Indian Pharmabiotech and other automated heavy industries Seems ignoring this ❗️I don't think they fully understand the magnitude of this situation. ❗️Approximately a million computers, primarily corporate ones, are rendered inoperable globally. ❗️This isn't merely an online service outage for a few hours. Each affected computer requires a reboot in safe mode, and manual removal of driver. Or wait for service ❗️Most corporate-issued computers don't permit employees to perform this task themselves. ❗️ how it translates to an operation is nightmare flight hotel booking is still ok but imagine #Cell and Gene Therapy #CGT #Vaccine #Automation #CSV #Digitalization

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Indian Pharma Manufacturers are Dominating Exports 💊 💉 🌍 The Nifty Pharma Index has surged over 5% in the past month and is up nearly 18% year-to-date. Indian pharmaceutical manufacturers are excelling in export markets, with domestic market growth further boosting their performance. The Indian Pharma market grew steadily at 10% in May 2024, up from 8.9% in April 2024. This growth is impressive given the high base of May 2023, which saw a 10.3% increase. The chronic product segment continues to support growth, while the acute segment is gaining momentum. Top performers among the top 20 pharma companies include Glenmark Pharmaceuticals with 18.9% year-on-year growth and JB Pharma with 13.1% growth. Ajanta Pharma, Zydus Lifesciences, Mankind Pharma, Cipla, and Sanofi India also posted significant gains. Some companies underperformed, such as Pfizer, Indoco Remedies, GSK, IPCA Laboratories, and Alembic, with 1-7% YoY growth. Over the past six months, Torrent Pharmaceuticals, Abbott, Lupin, JB Pharma, and Zydus have gained the most market share. Conversely, Cipla, Aristo, GSK, Alembic, Pfizer, Alkem, Glenmark, and Sun have lost market share. Analysts are optimistic about sustained IPM growth due to improved field force productivity, price hikes in non-NLEM portfolios, new launches, and increased sales. #pharmaceuticalsales #healthcare #pharmaindustry #pharmamanufacturing #sunpharma #pfizer #cipla Source:Janardhan Boyapati

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PharmaBusiness Shift in Indian Pharma Landscape: Branded Generics Losing Share to Rapidly Growing Pure Generics Branded generics continue to dominate the Indian pharmaceutical market, although their share has declined over the past five years due to the growth of pure generics. Here’s a look at the changes in value market share: Five Years Ago: Generics (Generic-Generic): Five years ago, pure generics held approximately 15-20% of the market in value terms. While they were widely used in volume, their lower pricing kept their value contribution relatively modest compared to branded generics. Branded Generics: Branded generics commanded a substantial 80-85% of the market in value terms. This dominance was due to their premium pricing, strong brand recognition, and continued preference among higher-income consumers and in urban centers. Current Scenario: Generics (Generic-Generic): Today, the value market share of pure generics has increased to roughly 25-30%. This increase reflects not only their growing volume but also strategic moves by some generic manufacturers to differentiate through quality, thus justifying slightly higher price points in certain categories. Branded Generics: Branded generics now hold an estimated 70-75% of the market by value. While still significant, this share has reduced as more consumers and physicians shift to lower-cost generics, particularly in regions where affordability is critical. Additionally, the Indian government’s pricing controls on essential medicines have put pressure on branded generics’ profit margins. Factors Driving the Shift in Value Share: Pricing Pressure on Branded Generics: Price caps by the National Pharmaceutical Pricing Authority (NPPA) and increased scrutiny over drug pricing have restricted the pricing power of branded generics, reducing their value share. Rising Value in Generics: Generic manufacturers are increasingly targeting higher-value therapeutic segments and investing in quality standards, leading to improved acceptance of generics even in value-sensitive segments such as chronic therapies. Government Support and Initiatives: Government efforts to promote affordable healthcare, including initiatives like the Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP), have made generics more accessible, especially in rural and semi-urban areas. In summary, branded generics have seen their value market share decrease by about 10-15 percentage points over the past five years, largely due to competition from lower-priced generics and regulatory pricing pressures. Generics, meanwhile, have increased their value share as they capture more market segments and improve in perceived quality, reflecting a trend toward greater acceptance and value contribution in the Indian pharmaceutical market. www.pharmsstar.com

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