Most Leading Generic Pharma Companies to Watch in 2022

Most Leading Companies to Mr JP Pallos CEO PannonPharma Inc. PannonPharma Inc., the Stalwart Frontrunners of the Added-value Pharma Industry O?ers Generic Based BREAKTHROUGH Therapy Against SARS-Cov-2 in COVID-19 and Control over Pandemic

Editor’s Note A Paradigm Shift in the Global Healthcare fulfil additional drug expenses. In both cases, customers end up denying the consumption of prescribed drugs due to resources on complying with the physician’s prescribed their inability to afford them. drugs? With the rising costs of healthcare services globally, a greater percentage of customers’ out-of-pocket spending goes into buying drugs prescribed by their But it doesn’t have to be the case. Instead of completely physicians. Surprisingly, in recent years, this spending has denying it, they have an alternative of using generic drugs. far exceeded the overall medical spending, which is Generic drugs are pharma medicines that are not only cost- concerning for the government, customers, and the effective but perform the same role that a branded drug healthcare sector. would do. They have the same dosage, kinetics, strengths, quality, and intended usage. Approved by the FDA, generic drugs are being promoted in the market at a faster pace The scenario could be attributed to the pharmacy industry, today. which spends millions of dollars in its drug-making process. From conducting multiple drug-making and clinical trials—to wasting a billion dollars on product “If generic drugs can provide us the same therapy that a failure—until they reach a health-satisfactory innovation. branded drug, then why not give it a try?” Hopeful about cost savings, customers are starting to give it a thought. Realizing the increasing preferences towards generic drugs, They consider themselves rightful for pricing their drugs to we at Insights Care, through our latest edition, “10 Most the level they desire and repeat this process until it drains Leading Generic Pharma Companies to Watch in 2022,” the customers’ health and financial resources overall. It is will be signifying the shift in the industry’s operations to impactful for them in all existing forms. reach where customers are headed. For those who are poor, the idea of drug affordability has Have an insightful read! gotten far out of their hands. Even the ones who, despite being insured, are required to spend out of their pockets to - Saloni Agarwal

16 PannonPharma Inc. PannonPharma Inc., the Stalwart Frontrunners of the Added-value Pharma Industry Offers Generic Based BREAKTHROUGH Therapy Against Rus Biopharm Interview with SARS-Cov-2 in COVID-19 and Control over Pandemic A One-Stop Solution for Insights Care Asthma and COPD CONTENTS 28 08 STADA Arzneimittel AG Interview with Legacy of Care with Insights Care High-quality Pharmaceuticals 24 Few Things in Life are Certain –Greater CXO Automation is One of Them! By- Graeme Ladds Articles 32 20 ARTICLES

Company Featuring Person Brief JAMP Pharma Corp. is commi?ed to suppor?ng healthcare Sophie Jacques JAMP Pharma Corp. professionals so that they may focus on what ma?ers Director of Pooja Bansal Editor-in-Chief jamppharma.ca most: the well-being of Canadians. Communica?ons Anish Miller Senior Editor MJ Biopharm Pvt. Ltd. is a growing mul?-na?onal Shrutika Khedekar Managing Editor MJ Biopharm Pvt. Ltd. Amol Shah conglomerate with a presence in Pharmaceu?cals, Biotechnological, Flavours, Fragrances, Agro Chemicals & mjgroup.co.in Saloni, Drishti Assisting Editors Managing Director Speciality Chemicals Industries. Co-designer Art & Design Head Visualiser David King Sonia Raizada Srinivasu Topalli Natco Pharma manufactures niche and complex pharma Natco Pharma products, making them accessible to all. Senior General Manager natcopharma.co.in Paul Belin Art & Picture Editor Mrunalinee Deshmukh Orchid Chemicals & Pharmaceu?cals is a ver?cal integrated Orchid Chemicals & company having a mul?-therapeu?c presence across Mridul Dhanuka Business Development Manager Amy Jones Pharmaceu?cals segments like an?-infec?ves, an?-inflammatory, central Director nervous system (CNS), cardio vascular segment (CVS), orchidpharma.com Marketing Manager John Smith nutraceu?cals and other oral and sterile products. Sarah Wilson, John Smith, Alex Vincent Business Development Executives PannonPharma Inc has been manufacturing Kelli, Bill, Anna Sales Executives Mr JP Pallos pharmaceu?cals and performing related pharmaceu?cal PannonPharma Inc research and development, as well as pharmaceu?cal CEO pannonpharma.hu analy?cal, and quality development ac?vi?es. Technical Head Jacob Smile David, Robert Amar Sawant Technical Consultants Assistant Technical Head Pharmathen S.A. aims to provide Life Cycle Management solu?ons for branded pharma, as well as develop and Dimitris Kadis Pharmathen S.A. establish new technology pla?orms, and provide op?mized CEO pharmathen.com pharmaceu?cal products to pa?ents. Alina Sege Digital Marketing Manager Renuka Kulkarni SME-SMO Executives Assistant Digital Marketing Manager Pharmax Pharmaceu?cals is a business of manufacturing Gemson and commercializing high quality, safe, efficacious, and Pharmax Pharmaceu?cals Sushmita Tamang cost effec?ve pharmaceu?cal products that exceeds the Pharmax.ae Research Analyst Eric Smith pa?ents and customer expecta?ons. Circulation Manager Tanaji Fartade PharSafar provides tailored solu?ons to act as a complete Graeme Ladds PharSafar pharmacovigilance, cosmetovigilance and medical services sales@insightscare.com CEO pharsafer.com department. September, 2022 Contact Us: Rhodes Pharmaceu?cals L.P—with its R&D capabili?es, Insights Success Media Tech LLC Insights Success Media and Technology Pvt. Ltd. industry partnerships, broad customer base, and strong Rhodes Pharmaceu?cals L.P Vincent Mancinelli 555 Metro Place North, Suite 100, Office No. 22, Rainbow Plaza, Shivar Chowk, rhodespharma.com rela?onships with suppliers—offers reliable supply of President high-quality products at compe??ve prices. Dublin, OH 43017, United States Pimple Saudagar, Pune, Maharashtra 411017 Phone - 302-319-9947 Phone - India: 7410033802, 74100058552 Email: info@insightscare.com Email: info@insightscare.com Rus Biopharm develops and implements innova?ve Satya Karm Punia Rus Biopharm For Subscription: www.insightscare.com For Subscription: www.insightscare.com approaches in biopharmaceu?cs, focusing on pa?ents rusbiopharm.ru President suffering from severe socially significant diseases. https://twitter.com/Insightscare Follow us on : www.facebook.com/InsightsCare/ Stada Arzneimi?el is a leading manufacturer of high-quality Peter Goldschmidt pharmaceu?cals. With a long-standing heritage rooted in Stada Arzneimi?el stada.com pharmacies, we are perceived as a reliable and trustworthy CEO Copyright © 2022 Insights Success Media and Technology Pvt. Ltd., All rights reserved. The content and images used in this magazine should not be reproduced or transmitted in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, without prior permission from Insights success. partner for more than 125 years. Reprint rights remain solely with Insights Success Media and Technology Pvt. Ltd. Insights Care is powered by Insights Success Media and Technology Pvt. Ltd.

Cover Story PannonPharma Inc. PannonPharma Inc., the Stalwart Frontrunners of the Added-value Pharma Industry Offers Generic Based BREAKTHROUGH Therapy Against SARS-Cov-2 in COVID-19 and Control over Pandemic PannonPharma's mission is to develop new medicines, new medical technologies, by inventing, repurposing, repositioning generics to generic+ pharmaceutical products. Mr JP Pallos CEO PannonPharma Inc

10 Most Leading Generic Pharma Companies to Watch in 2022 ack in the 1980s, a group of young research fellows, medical doctors, bio-analysts formed a B research group. They were investigating the metabolic changes of astronauts during their space flight, and in parallel, started to study cholesterol metabolism of PannonPharma's R&D team patients with hepatobiliary disorders. They pioneered continuously monitors the new instrumental chromatography, the HPLC, the revolutionary separation science on this field. This research project was treatment opportunities in supported by George Soros in the form of world class medicine and medical technologies scientific instrumentation. related to challenges by new This research work lead to discover the role of bile acids in infections and diseases. cholesterol metabolism and to understand its role in "high cholesterol level associated diseases." Despite the hard working, promising results, the golden age of "statins" as pharmaceuticals, made it impossible to commercialize the invention. But the knowledge they gained is not lost. High cholesterol level is the major risk factor of sever Covid-19, and mostly responsible for the coronavirus pandemic as well. disinfection of the GI tract, necessary to stop virus shedding by symptomless virus carriers, as well. This new treatment Their early results just need to be reevaluated when the first modality (patent application submitted) might be a life- papers published about Cholesterol role in COVID-19, saving treatment of COVID-19 patients and ought to be the which is a major key-risk factor and has a definitive role in Range of PannonPharma's Offerings Ø herbal substances for inhalation solution to subject of emergency market authorization by regulatory the pathogenesis and decourse of SARS-CoV-2 infection. disinfect the respiratory system and lungs bodies. Cholesterol is the question of death or life, and offers new The full scope of PannonPharma's activities covers Ÿ Free radical scavengers to treat oxidative stress diseases treatment modalities for COVID-19 patients. manufacturing of generics and original medicines (EU in virus infections, and vaccinations Non-systemic treatment is a mild medical intervention, as GMP), import and distribution medicinal products from Ÿ Complex health food supplement to tune the immune drug does not enter into the circulatory system, have no This research group and their work laid the foundation for third countries, drug regulatory affairs, sales, scientific and system up against viruses and vaccines effect on vital organs, therefore side effects are rather lower PannonPharmaInc. and among them was the company's technical research and development, medicine analytics, Ÿ Antiviral Cancer treatment by herbal substances in frequency. current CEO – J. P. Pallos. engineering, consulting. Its portfolio includes more than Ÿ Non-GMO superfood, virus-resistant and protein-rich seventy products: tablets, capsules, granules, solutions, potato varieties The active pharmaceutical ingredient (API) of this patented PannonPharma Pharmaceutical Inc. is more an R&D-driven sterile solutions, ointments, injectable and powder mixtures. antiviral therapy is the well known antimycotic drug generic plus pharma company than a large-scale There are new technologies rising on the horizon. Nystatin, with forgotten, repurposed antiviral activity. By pharmaceutical manufacturer. PannonPharma's R&D team PannonPharma Group of Companies is also a think-tank Reconstruction surgeries need precisely manufactured inhibiting the nasty fungy species, mostly Candida continuously monitors the new treatment opportunities in that offers simple solutions for complex problems. implants. PannonPharma's partnership company developed albicans, at the same time, Nystatin is capable to medicine and medical technologies related to challenges by the CT segmentation imaging technology, able to extract denaturalize the coronaviruses and their possible mutants as new infections and diseases. The innovations are based precise anatomic profiles from noisy CT recordings, in a They develop products to meet the unmet needs in the well, which are accounted as one of the major cytokine mainly on repurposing its portfolio with well-established therapy of: very short period of time. They plan to add value by storm inducers too. It can be used immediately, by use products. manufacturing tailor-made bone and 3D tissue cultured emergency use market authorizations. This is Ÿ Multi-resistant SA Staphylococcus aureus topical implants. PannonPharma's very last project, still open, for clinical PannonPharma is the only company so far, that offers ram treatment by primycin antibiotics, trials, one might be necessary afterwards. Investors are welcome! to the jab, a new solution to stop or alleviate the Ÿ To stop coronavirus: the API for COVID-19, SARS- What makes PannonPharma Stand Out coronavirus pandemic, where the barehanded jab is the CoV-2 virus eradication in: Mission: mandatory vaccination, which can strengthen by a ram, Ø GI tract – disinfection agents and their PannonPharma claims to be the only company that may which is the gastrointestinal (GI) SARS-Cov-2 virus combinations, contribute to stopping, alleviating the SARS-CoV-2 PannonPharma's mission is to develop new medicines, new disinfection by the newly discovered virus structural Ø Nose – Nasal drops, spray by interferon, pandemic, by non-systemic viral disinfection of the GI medical technologies, by inventing, repurposing, disrupter. Ø Eye – eye drop, tract, repurposing cholesterol-binding Nystatin drug. Its repositioning generics to generic plus pharmaceutical Ø Ear – ear drops, antiviral activity is a very robust one, destroys the envelop products, having active substances with well-documented The company's new paradigm is a non-systemic treatment structure of all coronaviruses and their mutants, too. safety and beneficial effect in therapies. to eradicate SARS-CoV-2 in the intestines, i.e. viral

The ongoing pandemic shall be controlled applying two principles of social defense: the first is vaccination of masses, as a systemic treatment, as much as possible. The second one must be a non-systemic treatment of GI disinfection, eradication of the virus from the intestines. PannonPharma is the only This non-systemic treatment is also mandatory because the company so far that offers a new infection in the GI tract may cause damage to the intestinal solution to stop or alleviate the barriers. This viral attack on vital organs via circulation (viremia) may cause clinically severe or fatal conditions in coronavirus pandemic, where patients. The persistence of the virus in the GI tract may vaccination is just the first. lead to post-COVID symptoms and further re-infections. Worldwide, there are generic 'me too' companies making one-to-one copies of original drugs, and there are generic plus innovation driven pharmaceutical companies, like PannonPharma. Awards and Accolades The company does repurposing for extension of Mr J. P. Pallos was awarded the 'TOP 100 Hewlett-Packard therapeutical indication of drugs, with well-known API or Employee Award'. added-value reformulation of well-known active pharmaceuticals. These new treatment modalities might be Mr J. P. Pallos is a member of the board of Europharm of high value. SMC Association of Pharmaceutical Manufacturers of the European Union. The Cultivated Leader The Pandemic Dictate From East to West, Mr J. P. Pallos was pioneering the beautiful epoch where technology meets science. A SWOT analysis about the introduction of the pandemic on the global pharma industry specifically, might better He had the privilege to start his pharmaceutical industry explain the effect COVID-19 has had: career at the famous innovation-driven company, Hewlett- Packard Inc's Analytical Instruments Division, now called Strength – the pharma industry is one of the major role Agilent, in 1987. Arriving from the East-Block, he was the players to have control of the pandemic. funny guy in the focus or interest of the whole company, the first direct HP head-count employee from the communist Weakness – means all modalities of treatment shall be world. He got the task, to his carrier, from the President of carefully investigated. Vaccination, by itself, is not HP during their face-to-face short meeting in Vienna, satisfactory to stop the pandemic. Austria. Opportunities – complex problems may require simple In 1987, John A. Young advised Mr Pallos to conquer solutions for a new paradigm. Hungary for HP Analytics Instruments. He did that and supplied the best instrumentation and technology from HP Threats – monopolies in the supply of life-saving drugs Analytic Division to the pharma companies. resulting in weakness in any state defense. By far, separation sciences have played a major role in From the point of view of the industry, COVID-19 acts as a medical, chemical, material disciplines over the past 50 kind of catalyst: it accelerates development and digitization years. No technology, no scientific progress is accountable processes, facilitates the cooperation of actors, etc. On the without chromatography, electrophoresis, technics, and other hand, it also causes unforeseen difficulties, such as instrumentation. Progress was made by US-based securing the supply of APIs. Hence, PannonPharma had to companies and they are leading the way. expand its manufacturing capacity to meet the needs.

Stay in touch. Subscribe to Insightscare Get Insightssuccess Magazine in print, & digital on www.insightscare.com The Future of Pharma When asked about his views on the future of the Pharma Industry, Mr J. P. Pallos answered, "The Pharma Industry is PannonPharma Group of depending highly on health (or 'wholeness' as it is defined Check should be drawn in favor of : in the Hungarian language for the word ‘health') policy. Companies is also a think-tank INSIGHTS SUCCESS MEDIA TECH LLC Nowadays, the main interest is generated from diseases that offers simple solutions for management. Soon, the policy shall be that of repurposing pharma industries to health, or more appropriately, to complex problems. 'Wholeness' management. This is the only option for a brilliant future." Word to the Wise A Fortuitous Future Awaits… For the budding entrepreneurs and professionals aspiring to venture into the pharmaceutical industry, J. P. Pallos has Being an R&D company, PannonPharma is looking for these words of wisdom to share – "One needs to be a good R&D partnerships and investors for market development. health strategist, not just a good disease manager only. Its vision is growth by magnitudes. Strategy means to vision, see, plan, do, act for 'wholeness', as it is defined in the Hungarian language for the word "There are beautiful markets with immense demands, and 'health'.” we have products to supply the needs. The regulatory to these markets is a very specific one, and we shall run "As far as I can see, this industry is fully regulated, clinical trials, preferably in the US. This is the only growth transparent, and predictable. Any reasonable investment rate-limiting factor. We intend to out-license some of our will profit in time when the demand is realistic, and supply products through investment bankers and investors," is structured. And, most importantly, patients are always the concluded the astute CEO of PannonPharma – Mr J. P. first priority," he added. Pallos.

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Redefining Healthcare Costs The Role of Sustainable Generic Drugs in the MEDICAL SECTOR ustainable generic drugs are emerging as a game-changer in the medical sector. With rapidly rising healthcare costs, generic S drugs are becoming increasingly important as a cost-effective and sustainable alternative to expensive branded medicines. Generic drugs can offer the same therapeutic effects at a fraction of the cost, making them a viable and affordable option for many patients. Their effectiveness and affordability make them a practical solution to the increasing burden of medical costs. Moreover, they are widely available and often manufactured in large quantities, allowing them to be widely accessible. This makes them a reliable and cost-effective option for many people. As the medical sector continues to evolve, sustainable generic drugs are gaining greater recognition as an invaluable solution to rising healthcare costs. Overview of the Medical Sector The medical sector is growing at a rapid rate, driven by increasing healthcare costs and a growing population. A growing and aging population represent a large portion of this demand. In addition, many countries are experiencing economic growth, which has led to a higher demand for medical services and products. The medical sector is expected to grow by more than 5% annually, which is more than double the average growth rate of the global economy. This sector generates over $10 trillion in revenue and employs millions of people. As the medical sector continues to grow and evolve, sustainable generic drugs are emerging as a game-changer in this industry. With rising healthcare costs, generic drugs have become increasingly important as a cost- effective and sustainable alternative to expensive branded medicines. www.insightscare.com www.insightscare.com September | 2022 September| 2022 20 21

Advantages of Sustainable Generic Drugs effects at a fraction of the cost, making them a viable and affordable option for many patients. Generic drugs are cost-effective and sustainable alternatives to expensive branded medicines. They can offer the same Their effectiveness and affordability make them a practical therapeutic effects at a fraction of the cost, making them a solution to the increasing burden of medical costs. viable and affordable option for many patients. Their Moreover, they are widely available and often effectiveness and affordability make them a practical manufactured in large quantities, allowing them to be solution to the increasing burden of medical costs. widely accessible. This makes them a reliable and cost- Moreover, they are widely available and often effective option for many people. As the medical sector manufactured in large quantities, allowing them to be continues to grow, sustainable generic drugs are gaining widely accessible. This makes them a reliable and cost- greater recognition as an invaluable solution to rising effective option for many people. There are several reasons healthcare costs. why generic drugs are more sustainable than branded medicines. Firstly, their research and development costs are Examples of Sustainable Generic Drugs lower since they do not require any clinical studies. Due to this, they are often produced in large quantities and are Generic drugs are cost-effective and sustainable alternatives widely accessible. Furthermore, generics are made from the to expensive branded medicines. They can offer the same same active ingredients as branded medicines, which therapeutic effects at a fraction of the cost, making them a ensures therapeutic effectiveness. viable and affordable option for many patients. Their effectiveness and affordability make them a practical Challenges with Sustainable Generic Drugs solution to the increasing burden of medical costs. Generic drugs are cost-effective alternatives to expensive Moreover, they are widely available and often branded medicines. However, they do experience manufactured in large quantities, allowing them to be challenges that can jeopardize their sustainability. For widely accessible. This makes them a reliable and cost- example, they are often manufactured in small quantities. effective option for many people. As the medical sector This means they are not always widely accessible, and the continues to evolve, sustainable generic drugs are gaining amount of supply is often not enough to meet the growing greater recognition as an invaluable solution to rising demand. As a result, there may be a delay in shipping or healthcare costs. availability of the product. Conclusion Due to these challenges, the supply of generic drugs may not always be consistent. This can lead to interruptions in Sustainable generic drugs are emerging as a game-changer treatment, which can be problematic for patients who need in the medical sector. With rising healthcare costs, these a regular supply of these drugs. Another challenge with drugs are becoming increasingly important as a cost- generic drugs is the quality of the product. While these effective and sustainable alternative to expensive branded drugs are therapeutically equivalent to branded medicines, medicines. These drugs can offer the same therapeutic they are not subject to the same rigorous testing as their effects at a fraction of the cost, making them a viable and branded counterparts. This means that generic drugs may affordable option for many patients. not meet the same quality and safety standards as branded medicines, which can be problematic for patients who need Their effectiveness and affordability make them a practical reliable treatment. solution to the increasing burden of medical costs. Moreover, they are widely available and often Impact of Sustainable Generic Drugs on the Medical manufactured in large quantities, allowing them to be Sector widely accessible. This makes them a reliable and cost- effective option for many people. As the medical sector Sustainable generic drugs are emerging as a game-changer continues to grow, sustainable generic drugs are gaining in the medical sector. With rising healthcare costs, generic greater recognition as an invaluable solution to the rising drugs are becoming increasingly important as a cost- healthcare costs. effective and sustainable alternative to expensive branded - Anish Miller medicines. These drugs can offer the same therapeutic www.insightscare.com September | 2022 22

Few Life Certain is By- Graeme Ladds Current Industry Situation In Europe alone, since the introduction of numerous pieces of revised and additional hroughout the years, pharmaceutical companies, for legislation in 2021, as a cumulative result of macro About the Author their developmental and marketed products, have factors such as Brexit and the Covid-19 pandemic, Graeme Ladds, CEO T continuously worked towards ensuring their adverse reaction reports have increased significantly products comply with the varied, numerous, and extensive – with the number of reports being submitted per year With a first degree in Biochemistry and Pharmacology, and a Ph.D. focusing on drug metabolism legal safety/medical obligations – established and put in now at an all-time high. and Pharmacokine?cs, Graeme has worked in the areas of Drug Safety and Medical services for place by various national and international governing over 30 years. authorities and agencies – to ensure the appropriate level of As a result, this has placed an increased demand within vigilance is upheld in accordance with the safety the drug safety Departments of Companies for adverse Graeme has been working as Head of Global Pharmacovigilance for a mul?-na?onal innovator requirements of each region. event case processing and analysis duties and has inevitably Company and EU QP PV for several of the top ten Pharma Companies, large generic and smaller led to the subsequent, ever-increasing demand being placed innova?ve Pharma, and is also the CEO of PharSafer® – a posi?on held for the last 19 years. Since the 1960s, the number of adverse reaction reports on employee output and labor; the need for new and received by pharmaceutical companies, Market additional staff; the associated cost of hiring and properly Furthermore, Graeme is also a member of the DIA; TOPRA; RQA, PIPA and MAPS and has helped Authorisation Holders (MAHs), and regulatory authorities training said staff initially and long term, and the added small start-up Companies (Biotech; Advance Therapy; Medical Devices; Biologics; Generics; has risen year after year – a trend which continues to rise to pressures placed on ensuring processing timelines are met Herbal; OTC) in their planning and growth, and has been involved in Company and product this day, with the emergence and exponential growth of in accordance with regulatory requirements. acquisi?ons, due diligence ac?vi?es for product in-licensing and marke?ng, and development markets such as the cosmetics and medical device industries strategies with partner and distributor Companies. and the additional legislative changes for all of these areas Moreover, this concern is one already shared by major bring to the wider pharmaceutical industry, giving reason to industry stakeholders, with notable bodies such as the Addi?onally, Graeme has been involved in many drug-development programs, taking products believe this rise will show no sign of slowing any time World Health Organisation (WHO) and European from the bench to market in a wide range of therapeu?c areas, and also has an addi?onal role as soon. Medicines Agency (EMA) highlighting the implementation Research & Development Director for products to be developed for global launches. www.insightscare.com www.insightscare.com September | 2022 September| 2022 24 25

of automation as a key factor in addressing issues with In order for governing and guiding authorities such as the increasing safety reporting demands and combating the WHO, FDA, PDMA, and EMA to ensure their goals of increasingly inaccurate and poor quality of case reports greater levels of ensuring safe and effective products and respectively. patient well-being on a global scale are achieved, the wider industry will require companies and MAHs to innovate and The Importance of Finding a Solution streamline processes supported by seeking an automated leap into the future of data entry and safety reporting and, in In recent years, most notably as a result of the Covid-19 doing so, industry stakeholders will not only see their issues pandemic, the subject of patient safety has excelled to new resulting from the ever-rising demands placed upon the heights, with many areas of regulation have been and still workforce addressed, but improved to levels not previously being extensively reviewed and updated, and greater levels seen before. of public interest and involvement leading to large proportions of both patients and consumers becoming more Through a greater implementation of automation, aware of the requirements placed on industry organizations companies will now expect to see the human element of and MAHs. This is paired with industry companies and data entry repositioned towards analysis duties – freeing up MAHs being required to adapt, update and outright change professionals and enabling them to better utilize their skill their company processes to align with any amendments sets and apply their knowledge towards finding solutions to made to regulation and case volume increases, usually to potential safety issues – with manual case data entry set to scales and within timespans previously otherwise unseen become something overseen and driven by automated during this period. processes. Furthermore, when looking beyond the realm of safety data The greater implementation of automation will allow safety capture, reporting, and obtaining follow-up information and professionals to better concentrate on their analysis duties, towards the wider pharmacovigilance activities, due to the providing greater levels of job fulfillment by removing the activity of case processing is instrumental to ensuring a growing pressures felt from increased manual case company can best address potential new safety information processing; removing any repetitious procedures associated relating to their product, issues with inaccurate and poor with data entry; eliminating human errors that result quality of data processing have a direct, negative impact on directly from issues with reporting quantities and the reliability of safety data analysis duties such as signal timescales, whilst also maximizing the efficiency and affordability of case processing through superior global detection, periodic report writing, and benefit-risk coverage; unprecedented reporting capabilities for both determinations. quantity and timescales; enhanced disaster recovery and business continuity processes, and reduced costings Consequently, the ever-rising demand being placed on typically associated with staffing recruitment and initial and safety reporting activities – in line with the aforementioned on-going training. factors – has ultimately resulted in an unsustainable strain being placed upon the wider industry, with the unavoidable Furthermore, by addressing issues associated with case outcome of serious regulatory findings originating from processing and enhancing vigilance over the first phase of inaccurate data, incomplete data, and reduced quality of safety reporting processes, improving the efficiency, data reported together with failing compliance becoming consistency, and accuracy of safety data capture and more of an eventuality than a possibility. collection will undoubtedly result in a positive, knock-on The Solution effect on the quality and speed of analysis activities and promote greater levels of global patient safety for years to For these reasons, the need for greater levels of automation come. within the pharmaceutical industry and, more specifically, drug safety has never been greater. www.insightscare.com September | 2022 26

Interview with Insights Care st Since September 1 , 2018, Peter Goldschmidt is the CEO of STADA Arzneimittel AG. He strongly pursues the STADA vision, to be the partner of choice in generics, speciality medicines and consumer health in Europe and selected emerging markets, while continuously outgrowing the industry in terms of growth and profitability. Peter Goldschmidt has 30 years' experience and success in the pharmaceutical industry. He worked in OTC, Generics and the innovative Legacy of Care with High-quality Pharmaceuticals Pharma Business in Asia, Europe and the US in several different leadership functions. Over the past three years at STADA, Peter harmaceutical companies the world over patent the STADA focuses on a three-pillar strategy consisting of Goldschmidt has led the group on a cultural drugs that are derived from their own research. This generics, speciality pharma, and non-prescription consumer journey, implementing a growth mindset culture allows them to have a monopoly in the sales of a healthcare products. Worldwide, STADA Arzneimittel AG P based around the common purpose of "Caring product for many years and these companies do not have to sells its products in approximately 120 countries. Consumer for People's Health as a Trusted Partner". By worry about competitors when setting prices. Hence, they Healthcare brands such as Zoflora®, Grippostad®, Snup®, ensuring that all of STADA's almost 13,000 can charge as high a price for products as they want. Aqualor®, Vitaprost® and Nizoral® are among the top employees worldwide truly live the four STADA sellers in their respective product categories. In the financial values of Agility, Entrepreneurship, Integrity But once an initial supplier’s patent, which generally lasts year 2020, STADA achieved group sales of EUR 3,010.3 and One STADA, he has led the group in up to 25 years, expires, other manufacturers of medicines million and adjusted earnings before interest, taxes, consistently delivering above-market sales and can also produce these long-standing pharmaceutical depreciation, and amortization (EBITDA) of EUR 713.3 profit growth. As a top-five supplier of both products and sell them at significantly lower prices. These million. As of 31 December 2020, STADA employed generic and consumer healthcare medicines are called ‘Generics’. 12,301 people worldwide. products in Europe, STADA helps millions of people to Generics are pharmaceutical drugs that contain the same “At STADA, we follow our purpose of ‘Caring for people’s lead healthy, dignified active pharmaceutical ingredient as the first supplier’s health as a trusted partner’,” remarked the Chairmanof the and fulfilled lives. proprietary product. Generics are significantly less Executive Board and the trailblazing CEO of STADA expensive, despite their great quality. A leading manufacturer of high-quality pharmaceuticals, with a long-standing heritage rooted in pharmacies, is the Germany-based company that has carved itself a legacy of Quality and care with high-quality pharmaceuticals – STADA responsibility towards Arzneimittel AG. all those who use its STADA is highly regarded in the pharmaceutical sector as a products and services is reliable and trustworthy partner for over 125 years. With its products, STADA helps protect people and regain a a fundamental dignified and able life. With its proven Generics, the component of STADA's company ensures that everyday health remains affordable. corporate strategy. And for its employees, STADA facilitates an attractive working environment in which they can develop personally. Peter Goldschmidt www.insightscare.com September | 2022 28

Today, the company is a leading manufacturer of high- quality pharmaceuticals. With a long-standing heritage rooted in pharmacies, the STADA Group is a reliable and Our strategic priorities and values are the trustworthy partner for more than 125 years. basis of our entire commitment to sustainable development in order to lead Purpose: Caring for people’s health as a trusted partner sustainable business and growth while Vision: To be the partner of choice in generics and achieving a positive impact on people and consumer health, while continuously outgrowing the their health, the economy and the industry in terms of growth and profitability. environment. And we bring these to life every day. For us, caring for people's Core Values: health is more than providing support for prevention and treatment through a Integrity – “Each and every one of us acts ethically in line with the company's internal and external standards. Our complete range of STADA's quality, actions are led by speaking up and respect.” reliable and affordable pharmaceutical products. It also involves raising Entrepreneurship – “Each and every one of us drives new awareness of personal health care and ideas and actions, creating future growth and value.” healthy lifestyles, while supporting public health care systems. Further, it is our civic Agility – “Each and every one of us leads change with flexibility and decisiveness as part of our ongoing journey duty to act as responsible citizens - we as of personal development.” individuals, we as a team and a society. This is exactly what makes us a partner of One STADA – “Each and every one of us acts in the best trust and choice when it comes to interests of the company as a whole rather than our business people's health. unit or function in order to build one successful STADA.” roup – Peter Goldschmidt. “In pursuit of this purpose, Quality at STADA we are committed to further accelerating the successful G trajectory of our company,” he added. Quality and responsibility towards all those who use its products and services is a fundamental component of Caring for People’s Health STADA's corporate strategy. It thereby takes account of the great significance of quality in product safety in the health As all success stories do, STADA Arzneimittel's company care market. Overall, the company aligns the quality policy history started with a great idea. In 1895, a group of throughout the Group to meet criteria that at least fulfil the pharmacists had a common objective: The standardized strict legal requirements for pharmaceutical and health care production of medicinal products to ensure an effective and products. reasonable provision of healthcare for the many. This was the beginning of STADA” impressive development. “Assessing the risks of newly arising, previously unknown side effects of active ingredients also play an important role in the quality of pharmaceutical products,” explains the astute CEO, Peter Goldschmidt. “This risk remains low for With its products, most of our products as only long-standing and researched STADA helps active pharmaceutical ingredients are generally used. Of course, we have nevertheless implemented within our protect people and operations all the standard graduated plan proceedings for regain a dignified recording or detecting such pharmaceutical product risks throughout the Group,” he elaborated. and able life. www.insightscare.com September | 2022 30

Top Technological Trends Revamping the Pharmaceutical Niche imple sayings often have deep engraved meanings and one of the old saying is, ‘Health is wealth’. S Understanding that individual could progress best in the good health conditions, has taken the health sector to new heights of invention. Stormed with new healthcare inventions with time, one of the most important parts of it has been taken by technology. Growing technological involvement in Medicare has led to a reduction of lots of risks while coming up with better facilities and cures unimaginable a few decades ago. With the touch of tech Pharmaceutical industries are at immense benefits. With ever-changing trends in the industry let us see the amazing developments in pharmaceuticalfield topping the list. The Spark of Artificial Intelligence (AI) Talking about technological development without AI is nearly unimaginable. AI is a technology that has crept into almost every field including pharm. The technology is used in pre-clinical trials of drug designing procedures which has considerably reduced health hazards involved in it. This entire use of AI during each step of the process has also considerably reduced the cost of the procedure benefiting industries. Being an effective tool for mining data, AI, manages clinical trial databases while maintaining, organizing, and storing the data securely. www.insightscare.com www.insightscare.com September | 2022 September| 2022 32 33

Connecting the Wireless: IoT like any pill. It allows medical professionals to monitor their patients ensuring they are following the dosing Along with AI, IoT or the internet of things has enabled schedule recommended. The pills are embedded with end-to-end digital integration in the value chain. electronic circuits and sensors which are edible and send Accompanied by Big Data analytics along with cognitive messages to operative devices such as smartphones, systems, IoT has created even better chances of patches, or tablets. development in the field of medicine and Pharm. This is magic for doctors looking after rebel patients as it In the pharmaceutical sector, IoT aids in various activities helps them keep tabs on them. starting right from the initial stage to the intermediate process. Used to monitor real-time data, supervise unit Med for You: Precision Medicine operations, and enhance product efficiency, IoT has made the tasks of the industry a lot easier. It has become a reliable The belief that every individual is unique and thus requires technology for the pharmaceutical sector despite being in its treatment accordingly is the underlying principle of infant stage. Precision medicine. The initiative involves the study of biological indicators based on personality traits, genotype, VR, XR, MR: New Dawn in Pharmaceuticals genetic code, age, gender, etc., and tailoring individual- specific treatment. Virtual Reality (VR), Extended Reality (XR), and Mixed Reality (MR) are some of the fascinating children of The technology determines the pharmacokinetic and technology that many restricted to the world of games. pharmacodynamics properties of drugs and arrives at a However, with time and the development of these point of precision for the dosage of drugs. technologies they have released their potential in various fields. Cure Over Temporary Relief: Curative Therapies These technologies comes to the rescue, as it provides a Being for long time under research curative therapies have structure and allows one to experience the technology or risen to popularity in the field of Medicare. The therapy structure before it is created. Precision is one of the most provides a time-limited treatment for underlying disease important factors while building a structure specifically in and symptoms. The driving motive of the therapy is to cure the pharmaceutical industries that require extra care as there patients instead of just reducing pain or stress. are more chances of hazards during experiments. This real- life experience helps in the reduction of hazards and gives a These therapies deal with chronic diseases and difficult better idea of manufacturing. conditions. Digital Twins: Project for Experiment The therapy includes modification in gene material to help with the diseases. Chemotherapy could be classified under Used for testing and monitoring purposes, Digital twins is a curative therapies as it intends to cure cancer patients. technological boon that is a virtual representation of systems or objects updated by real-time data. As fascinating With the time these trends would certainly change further, as it sounds the technology helps companies to test products be replaced and modified, however, one thing that remains before actually creating them. constant is evolution. We, humans, have evolved with time, and with us, we have evolved the world surrounding us A replica of the planned project is created using this which is a continuous process leading us to the future. With technique where engineers can identify the potential time health and the environment has also raised to the process failures before the project is created. priority list and I hope it remains so. Alert! Patient Update: Digital Pills As it’s said ‘Health is Wealth.’ Digital pills, as weird as it sounds it is a reality of the day - Anish Miller approved by the FDA, this pill is an amazing contribution to the field of medicine. The pill is ingested by patients just www.insightscare.com September | 2022 34

Most Leading Generic Pharma Companies to Watch in 2022

Most Leading Generic Pharma Companies to Watch in 2022

Presentation Transcript

Commercial and Government Pricing Projects at Leading Generic Pharma Co.

Commercial and Government Pricing Projects at Leading Generic Pharma Co.

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