Sumit Luthra

How do you quantify and analyze in a rare matrix? I am proud to share that Dr. Prajita Pandey, Assistant Director of Chemistry at Emery Pharma, has developed an LC-MS/MS method for quantitating a small molecule in vitreous humor using human plasma as a surrogate matrix. This approach, aligned with ICH M10 guidelines, addresses bioanalytical challenges such as matrix interference and analyte instability. The method’s robust validation includes specificity, recovery, carryover, stability studies, and parallelism to ensure accurate and precise results. By employing a surrogate matrix, this strategy enhances detection limits and method reliability, offering a cost-effective solution for bioanalysis in challenging matrices.. #LCMS #bioanalysis Moji Bonakdar Ryan Cheu, Ph.D. Hui Zhao Emmett Cunningham Bill Galush Adrienne Graves Eric Donnenfeld https://lnkd.in/grHCyTz4

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In FY24, Indian pharma exports to the U.S. reached $7.83 billion, a significant increase from $6.8 billion in the previous year. This growth has been driven by the affordability and quality of Indian-made drugs, which are often much cheaper than their American counterparts due to lower manufacturing and labor costs.   This isn't the first time Indian pharma companies have faced regulatory challenges in the U.S. This led to a ripple effect, not only hurting pharma market share of Indian companies but also affecting the availability of certain generic drugs in the U.S.   Several factors could be driving this increased scrutiny.   Firstly, the U.S. pharmaceutical industry is one of the most powerful lobbying groups in Washington. The industry has a vested interest in maintaining high drug prices, which are often justified by the costs associated with research and development (R&D) and the complex regulatory approval process. Indian generics, which are significantly cheaper, threaten this pricing structure. By leveraging regulatory bodies like the FDA, Big Pharma can slow down the entry of these cheaper alternatives into the U.S. market.   Secondly, the geopolitical landscape plays a role. As the U.S. seeks to reduce its dependence on Chinese pharmaceuticals, Indian companies have emerged as a preferred alternative. However, this shift has not been without resistance from domestic players who see their market share eroded by these foreign competitors.   The primary beneficiaries of this increased regulatory scrutiny are U.S.-based pharmaceutical companies. By stalling the entry or continuation of Indian generics in the U.S. market, they can maintain higher prices and protect their market share. Also, the scrutiny may benefit other international competitors who are not facing the same level of inspection and can fill the gap left by Indian companies.   On the other hand, U.S. consumers are likely to suffer. The removal or delay of Indian generics from the market could lead to higher drug prices and reduced access to affordable medications. This comes at a time when the cost of healthcare in the U.S. is already a significant burden for many.   The FDA's actions against these Indian pharmaceutical companies appear to be part of a broader strategy to protect domestic interests under the guise of regulatory compliance. While the need for stringent quality control cannot be understated, the timing and frequency of these notices suggest that they are being used as tools to limit competition.     News: https://lnkd.in/dr5q__cs

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India is streamlining the regulatory landscape for stem cell and gene therapies with proposed amendments to the Drugs and Cosmetics Rules, 1945 and updates to forms 27D, 27DA, 28D, and 28DA will now cover: * Cell and Stem Cell-Derived Products * Gene Therapy Products * Xenografts This move simplifies licensing, accelerates access to life-saving treatments, and positions India as a global leader in advanced therapies. A promising leap toward a healthier future! #StemCell #GeneTherapy #Innovation #IndiaBiotech #HealthcareLeadership

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#secret The secret to being great at sales? It’s simple – we believe in what we’re selling. When we truly trust our product or service, it shows in every conversation. Our energy becomes contagious, and clients can feel that authenticity...... #people don’t just buy products, they buy the confidence and passion we have for them. selling with heart is the need, not by just words...... keeping it real & genuine is the need.... #SalesTips #SalesLife #BelieveInYourProduct #AuthenticitySells #SalesMindset #TrustTheProcess #CustomerConnection #BeGenuine #SellWithConfidence #SalesJourney #SalesHustle #SalesSuccess #PassionForSales #RelationshipBuilding #SalesSkills #PositiveVibes #RealTalk #SalesStrategy #SalesGoals #WinWithConfidence #KeepItReal

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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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Excited to share the latest feature in our "Partnering Spotlight" series, where we share some of the connections we are building to foster scientific innovation in healthcare. In this edition, our very own Neha Kaushal sits down with Daniel Anderson, Professor of Chemical Engineering at MIT, to discuss the potential of innovative #mRNA applications in vaccines and novel treatments for genetic diseases. Check out the video to learn more about our collaboration! https://lnkd.in/eHwpyjeY #vaccines #immunoscience

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You can imagine how big we are talking about when it's 15000 crore. Yes, that’s right. The Indian Government has allocated this budget for APIs and bulk drugs, primarily through Performance Linked Incentive (PLI) schemes. But why? India's CDMO industry is anticipated to grow from $22.51 billion to $44.63 billion by 2029, driven by increased demand. As I was reading more about it, I learned that India currently holds only 2.7% of the global market share, compared to China's 8%. While discussing this with my team, they were enraged by how it affects the #pharmaceutical market. The catch is in the US Biosecure Act. This aims to decouple supply chains from China, presenting significant opportunities for India's pharmaceutical industry. The Act will disrupt American supply chains, affecting clinical trials and drug manufacturing processes. In fact, the Biotechnology Innovation Organisation (BIO) supports the Act despite concerns about its potential challenges. India holds the upper hand here because it supplies 40-50% of all generic drugs in the US, positioning itself as a strong alternative to China. I have personally sat down to thoroughly analyse this stance. Working tirelessly for months to get Pinnacle’s Oncology hub FDA-approved at Baddi made me realise how crucial this geopolitical shift could be. The USFDA has flagged 13% of Indian facilities for non-compliance with good manufacturing practices. This sums up and justifies the investment of 15,000 crore. Keeping all this in mind, the momentum from the Biosecure Act could solidify India's role as the "pharmacy of the world." #USFDA #IndianPharmaceuticals

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"The Medicine world has been evolving year after year and modern science meets ancient wisdom, one thing remains constant: the pursuit of health and healing. As.... Ayurveda continues to gain global recognition, several myths still surround this ancient system of wellness. So, Here are the Myths! Myth 1: Ayurvedic treatments have no side effects Reality: Like any medical treatment, incorrect use of Ayurvedic remedies can lead to side effects. It’s important to consult qualified RMP who understand your unique body constitution. Myth 2: Ayurveda is only about herbs Reality: Ayurveda offers much more, including dietary guidance, detoxification (Panchakarma), yoga, and meditation. It’s a comprehensive system that helps in...balancing the body, mind, and spirit. Myth 3: Ayurveda is outdated Reality: Far from irrelevant, Ayurveda's holistic approach is particularly effective in managing modern lifestyle disorders like diabetes and hypertension. Integrating AI and research, Poly Scientific Ayurveda is proving how science-backed Ayurveda can be a game-changer. Myth 4: Ayurvedic diagnosis is unreliable Reality: Diagnosis methods like #Naadi Pareeksha (pulse reading) offer deep insights, and today, digital technologies are enhancing the precision of these methods. Ayurveda is also a #science, deeply rooted in nature, and with the right scientific validation, it continues to transform healthcare. #Ayurveda #HealthcareInnovation #HolisticHealth #PreventiveCare #WellnessScience #MedicalAdvancement

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How #Postmenopausal Osteoporosis Leads to Heart Disease? It's not just about fragile bones....it’s intricately linked to cardiovascular diseases (CVDs). Here's the mechanism behind this connection: 1️⃣ Estrogen Decline: Menopause leads to a sharp drop in estrogen levels. Estrogen protects bones and maintains blood vessel flexibility. Its decline accelerates bone resorption and triggers inflammatory processes. 2️⃣ Calcium Imbalance: Bone loss releases calcium into the bloodstream. Excess calcium can deposit in arteries, leading to arterial calcification. 3️⃣ Inflammation & Oxidative Stress: Increased inflammation and oxidative stress damage blood vessels. This promotes arterial stiffness, atherosclerosis, and endothelial dysfunction. 4️⃣ Shared Risk Factors: Risk factors like obesity, diabetes, and hypertension overlap, amplifying the effects. 5️⃣ Increased Fracture Risk: Fragile bones and immobility due to fractures further worsen overall health, including cardiovascular strain. As a result of these mechanisms... #Women with #osteoporosis have a higher risk of heart attacks, strokes, and other CVDs. What Can Be Done? ✔️ Early Detection ✔️ Balanced Diet ✔️ Exercise ✔️ Medical Therapies A #healthy heart and #strong bones go hand in hand! #WomenHealth #PostMenopause #Osteoporosis #HeartHealth #CVDPrevention #HealthyAging #BoneHealthMatters

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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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Aseptic filling is crucial for ensuring the sterility and safety of drug products in addition to being compliant with regulatory agencies. Following procedures can be taken to ensure Proper Filling 1. **Controlled Environment and closed system:** Use cleanrooms with HEPA filters to maintain sterile conditions. 2. **Personnel Training and proper PPE:** Train staff in aseptic techniques and hygiene practices. 3. **Equipment Sterilization and calibration:** Regularly sterilize and ensure equipment is within calibration. 4. **Process Validation:** Validate aseptic processes through media fill tests. By adhering to these practices, the risk of contamination can be minimized, ensuring the safety and effectiveness of the drug product.

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“Hope is the word that comes to mind.” Great feet achieved by Indian biotech ImmunoACT for trimming down the cost of CAR T cell based therapies from ~$500,000 to ~$40,000. CAR T cell is an approach that can help treating life threatening diseases such as different types of cancers. Two challenges for this treatment to reach more patients have been the cost of treatment and toxicity. As a result, this treatment is given to patients with very severe disease manifestation as nearly the last resort and only if financial resources allow. ImmunoACT made innovative advances in various steps of the process to make CAR-T approach much more affordable as it is now available at 10% of the cost in India compared to western countries. Apart from the cost, the CAR-T approach here seems to have improved the safety profiles. The results look very promising in first 33 patients. Great news for cancer treatment in India. #india #biotech #CARTcells #cancer https://lnkd.in/eWuqGh4P.

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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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"The greatest wealth is health." – Virgil Diabetes is on the rise, both in India and the world! According to the recent ICMR INDIAB study, around 101 million people in India are currently living with diabetes. This staggering figure reflects this as a....global epidemic, with diabetes cases surging from 108 million in 1980 to 422 million in 2014. Key Facts: In 2019 alone, diabetes directly caused 1.5 million deaths globally, with 48% occurring before the age of 70. Increasing prevalence: Between 2000 and 2019, diabetes mortality rates increased by 3%, with a worrying 13% rise in lower-middle-income countries. Why This Matters? Diabetes is not just a personal health issue; it has profound implications for families, communities, and healthcare systems. It can lead to severe complications like: Blindness Kidney failure Heart attacks Strokes Lower limb amputations But....Prevention is Key! Many cases of type 2 diabetes are preventable through simple lifestyle changes! #DiabetesAwareness #PublicHealth #Prevention #HealthIsWealth #ICMRINDIAB

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Akums bags patent for formulation to manage sickle cell disease. Here are a few #PressCoverages of the patent news featured in the media. #Akums #Innovation #Healthcare #Pharma #Research #Indigenous #India #SickleCellAnaemia #SickleCellDisease #Hydroxyurea #PatentNews #Indian #PharmaceuticalInnovation #Drugs #BreakingNews #SCD #MedicineNews #PatentGranted #RoomTemperatureStable #Affordable #OralSuspension #Innovative #Med #MedicalBreakthrough #Patent #LowCost #Medicine #AffordableDrug #Health #Aim #HealthcareAdvancements #Breakthrough #AkumsDrugs #InnovativeDrug #Pharmaceuticals #Achievement #Disease #SickleCell #HealthcareAdvancement #AkumsDrugs #HydroxyureaNews

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#Newsupdate Biocon received EIR (Establishment inspection report) from FDA for their Greenfield API facility at Vizag, Andhra Pradesh. This now allows them to commence commerical supplies from this facility to US Market. EIR is Based on the Pre-Approval Inspection conducted by agency between 10-14 June 2024. #News #Pharma #Update #Newsupdate #Biocon #Vizag #Andhrapradesh #Andhra #India #API #active #pharmaceuticals #industry #business #US #FDA #commercial #inspection #EIR #Report

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Amneal Pharma to invest Rs 1,600 crore in Gujarat to make GLP-1 drugs Amneal Pharmaceuticals, is further investing up to Rs 1,680 crore ($200 million) over the next four to five years for peptide synthesis and advanced sterile fill-finish manufacturing. The company said on Tuesday that it will build two new manufacturing facilities in Ahmedabad with a total investment of $150–200 million. The company will develop and supply a portfolio of next-generation branded medicines for metabolic diseases and obesity, including GLP-1 and amylin receptor agonists, in collaboration with Metsera. Glucagon-like peptide 1 (GLP-1) agonists, a new class of drugs offering breakthrough treatment for diabetes and obesity, are estimated to be a $100 billion global opportunity by 2030. At present, there is a global shortage of GLP-1 products like semaglutide due to off-label usage for weight loss. Innovators like Eli Lilly and Novo Nordisk are scaling up production to meet this overwhelming demand.

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