Press Room

Welcome to the new “Science Turnaround” Series Our multinational team partners with global customers to help deliver lifesaving and life changing medicines for patients all over the world. Most of the projects we are involved in are complex and challenge us to innovate in order to allow our clients’ products to perform better.  In this new compilation of Case Studies presented by our scientists, we share how Hovione’s multi-disciplinary teams’ expertise, scientific rigor and out-of-the-box thinking allowed us to see alternative scenarios, accelerating progress and improving results.   Click on the image to play the video   Case Study #6 - “Enabling lean manufacturing with Process Analytical Technologies (PAT)" In this case study, Ricardo Sousa explains how a 20h bottleneck was eliminated by replacing a loss on drying method with NIR, decreasing the stocking time to 5 hours.   Case Study #5 - “De-risking scale-up of DPI formulations” In this case study, João Pereira and Beatriz Fernandes explain how to approach the scale-up of DPI formulations from lab to commercial scale by maintaining scale-independent blending parameters and the capsule filling mechanism, avoiding impact on processability and final product performance.    Case Study #4 - “Hazardous Chemistry at High Temperature” In this case study, Rudi Oliveira explains how a hazardous chemical process was approached and how continuous flow was applied to achieve a safer and more efficient process at scale.   Case Study #3 - "Understanding crystallization" In this case study, Filipe Vultos and Liliana Silva explain the approach taken to study the physical stability of a multicomponent amorphous solid dispersion formulation with the aim of achieving a better understanding of the crystallization events occurring during stability studies.   Case Study #2 - "Reduction of QC burden" In this case study, André Cruz explains how an analytical bottleneck, that resulted from a combination of a time-consuming analytical technique with a process that involved high throughput of samples, was approached and how Chemometrics allied with Near infrared (NIR) spectroscopy were applied to achieve a faster analytical response that potentiate the increase of productivity for both QC and Production areas.   Case Study #1 - “In water we go” In the first case study, Susana Lucas explains how a multistep chemical process was approached toward a new synthetic route to achieve an efficient and highly sustainable one-pot scalable process.       Wondering if your projects can achieve better results this year?   Contact our experts today          


Science Turnaround - Case Studies

May 06, 2021

  Dear representatives of the Commission, Dear Ministers, Ladies and Gentlemen, Good-Morning It is a privilege for me to address you.   Dear Pedro thank you for giving me this opportunity.   I have been fortunate to have a front row seat watching the Pharmaceutical Industry since I was born, that was 60 years ago. Hovione was founded by my father, a Hungarian refugee, in the basement of our home in Lisbon. Often as children we could not go into the garden because a bromination was going on a l’air libre for safety reasons! My first job in the family business, aged 24, was selling active ingredients made in Portugal to Indian firms in Bombay, Madras, Delhi and Goa.   I will start by telling you about the successes of our industry and end with our failures as these are the ones we need to collectively tackle.   10 years after the HIV virus was discovered in Paris and Washington, American companies invented the protease inhibitors that would treat this horrible disease. But who made these complex molecules industrially possible then were exclusively European companies.   In the last decade several cures for Hepatitis C were discovered. Over 4 million patients have been cured and ¾ of those with pills made with a Hovione process with product that came out of our plants in Portugal and Ireland.   It is also important to acknowledge the complexity of the manufacturing processes and the extreme specialization that each step requires. Remdesivir, one of 3 approved therapies for Covid-19 needs factories in two continents just to make the active ingredient, but it won’t work without an enabling excipient called Captisol® that Hovione makes exclusively. To face the pandemic’s tremendous demand we are now making per month what we usually made per year.   Europe has 600+ plants that have the science, the technology, the know-how and the capacity to be the workhorse of innovative medicines for global supply. For most of us it has been some time that we have stopped focusing on serving the generics industry of our home market, Europe. Hovione has not supplied one kilo of a generic API to Germany for 15 years because one cent of difference means the Indian product is preferred. Had we not exported to the USA and served innovators and generics there we would be bankrupt, or weak and unable to invest in R&D and new technology.   The beauty of the pharma ecosystem is that the very high prices of patented products pay for the R&D and the risk, but as soon as the patents expire the best science can be had for a few cents per pill. Innovative drugs, under patent, and the large multinationals are today a minority volume player – over 80% of prescriptions are filled by generics.   Today the EU is not in control of its generic medicines – we face frequent shortages and a geostrategic fundamental dependence for APIs and precursors from India and China – where serious accidents, government policies and market failures make us vulnerable.    We have ended up in this untenable situation due to 1) the unbridled market forces of globalization and 2) 30 years of EU regulations that failed to consider that pharma is an intensely globalized and highly competitive industry.   Europe was once the cradle of pharmaceuticals. In the 50s any American that wanted to study chemistry had to learn to speak German as all good text books were written in German. We have faced a 30 year decline – today in the top 10 largest generic firms in the world only 1 is European.     As an industry we survived by moving away from intermediates and generic APIs – including the essential ones – and focusing on high value innovative products. The world is competitive and if the climate in Europe in unfavorable to certain segments, factories move – it is that simple.   Nobody saw the unfolding of this radical structural transformation. Nobody heard Industry’s calls for levelling the playing field.     In 2004 the EU API industry founded EFCG, the European Fine Chemicals Group, a member of CEFIC, to level the playing field, this need remains.    In my first trip to Brussels to flag the growing risk to patients and the lack of level playing field, in 2005, I was met with bemusement, étonnement and some sarcasm. In 2007 I testified at a hearing of a sub-committee of the US congress in connection with the risks to patient from imported APIs. I went public and frequently said and wrote that EU Regulators inspected on proximity not risk. The contaminated heparin tragedy that killed over 150 patients occurred in 2008. By 2011 our advocacy work resulted in the Falsified Medicines Directive, too little, too late.    Today price pressure has driven the European Generics supply chain to, in 74% of cases, buy from low-cost countries. These production locations have low regulatory oversight therefore present higher risk to patient, often cause environmental damage and antimicrobial resistance because of poor control over wastes, and have a high frequency of deadly accidents – the EU industry cannot compete with such low standard, low cost operations.    In summary in the last 30 years a large part of the EU API and intermediates industry disappeared to the benefit of its competitors. Certain key technologies (eg fermentation, nitration, halogenation) almost disappeared from Europe. This represents a damaging loss of critical mass, as these technologies act as platforms that allow the production of many different APIs.  Fermentation is key to making many antibiotics. Without fermentation Europe is now totally vulnerable and dependent on supplies from Asia/China.   To reduce this dependence and to ensure the resilience of the medicines supply chains on the long term, the only solution is to rely on the robust, reliable, competitive and sustainable manufacturing capabilities we still have in Europe.   So what are Industry’s proposals in this regard?   First, we must support the existing European manufacturers of APIs and intermediates in the on-shoring of technologies that will guarantee the supply of the essential medicines. Dual sourcing of the essential medicines must be a cornerstone of our policies.   Second, level the playing field with other world regions to ensure that import and purchase requires not only verified compliance with GMPs, but also demands process safety, respect for the environment and an absolutely reliable supply chain. Linking the purchase of critical supplies to the sole criteria of price cannot be a sustainable supply strategy.   Third, we need a long-term EU industrial policy that can accelerate sustainable Research, Development and industrialization of innovative and green technologies, as well as manufacturing capacities within the EU territory.   Fourth, regulatory centralization, transparency and flexibility. EMA must be given more clout. We need a central record of EU shortages.  EMA must know the complete supply chain mapping of each medicine, so it can act. EMA should turn into a compliance matter the good example of the Swedish regulator that considers environmental aspects when granting permits and approving products and APIs.   We are optimistic that this straightforward strategy will be successful to eliminate not only existing drug shortages but more importantly avoid future risks of shortages.     Europe can rely on its the 600+ existing manufacturing sites, on its strong innovation capacity, its highly-trained workforce to reverse the trend and build back a robust pharmaceutical industry in Europe.   Industry is involved in the Commission’s EU Pharma Strategy Structured Dialogue. We are looking forward to working with the Commission to implement, as quickly as possible, the appropriate structural, pragmatic and efficient measures to support our industry.    However as we embark to build the future and drive a Renaissance of the European API and generic industry it is imperative that we first look into the past and understand what got us into this situation of dependence and weakness.    The US and Japan have already launched countermeasures, we must work with our allies and not independently.   An EU patient centric pharmaceutical industry needs a EU centric pharma supply chain with a sustainable EU manufacturing base, this requires deliberate and careful regulation to compensate for market forces and to correct the playing field.   European citizens deserve medicines that are Affordable, Accessible and most importantly Available.    Dear Commission representatives, you can count on me and on our industry associations to fill in the blanks, spend time analyzing the situation and design a solution for the future.   Thank you for your attention.   Guy Villax CEO, Hovione Lisbon, 22nd March 2021 PDF version       Find more about this virtual event at    


Guy Villax speech to the Informal Meeting of Ministers Responsible for Competitiveness

Mar 22, 2021

This year’s theme for International Women’s Day is #ChooseToChallenge to celebrate the achievements of women around the world. Today Hovione women also #ChooseToChallenge. From Portugal to the USA, Ireland, Macau and India, we celebrate our team’s achievements. Thank you to Beatriz Noriega Fernandes, Camie Lou, Kristen Parisi, Linda Cullinane, Louise Dennehy, Madhu Gautam, Mafalda Paiva, Marianna Katz, Marilena Ornelas, Mary Hennessy, Sarah Downing, Sarah Scott, Sónia Cardoso and Tânia Dias for raising their hands high.  From challenge comes change. Read their statements here.   O tema deste ano do Dia Internacional da Mulher é #ChooseToChallenge - Escolher Desafiar - para celebrar as conquistas das mulheres em todo o mundo. As mulheres Hovione também aderiram à campanha #ChooseToChallenge. De Portugal aos EUA, Irlanda, Macau e Índia, celebramos as conquistas da nossa equipa.   Obrigada Beatriz Noriega Fernandes, Camie Lou, Kristen Parisi, Linda Cullinane, Louise Dennehy, Madhu Gautam, Mafalda Paiva, Marianna Katz, Marilena Ornelas, Mary Hennessy, Sarah Downing, Sarah Scott, Sónia Cardoso e Tânia Dias por levantarem as vossas mãos. Do desafio vem a mudança. Leia os seus testemunhos aqui.     My name is Kristen and I’m a HR Business Partner at Hovione USA. My journey at Hovione has been one of my proudest professional achievements. I started June of 2017 in the capacity of a split role, supporting HR initiatives while maintaining office management. I have since been promoted twice and currently hold the role of HR Business Partner. Hovione provides the necessary tools and opportunities for TM’s to have a fulfilling and challenging career. O meu nome é Kristen e sou HR Business Partner na Hovione EUA. O meu trajeto na Hovione é uma das conquistas profissionais de que mais me orgulho. Comecei em junho de 2017 a apoiar iniciativas de RH enquanto mantinha a gestão do escritório. Desde então, fui promovida duas vezes e atualmente exerço a função de HR Business Partner. A Hovione fornece as ferramentas e oportunidades necessárias para que as Colaboradoras tenham uma carreira gratificante e desafiadora. Kristen Parisi - HR Business Partner Hovione USA     My name is Madhu and I’m a Director at Hovione India office. I believe in a world where everyone – regardless of their age, gender, religion, disability, sexual orientation, or ethnicity - is provided with equal opportunities and I share this belief with Hovione. To all my colleagues around the world I raise my hand: by working at Hovione we have committed ourselves to save lives and improve the quality of life of millions of patients. There is no limit to what we can do together. Be proud. Be happy! O meu nome é Madhu e sou diretora do escritório da Hovione Índia. Acredito num mundo onde todos - independentemente da sua idade, sexo, religião, incapacidade, orientação sexual ou etnia - tenham oportunidades iguais e partilho esta convicção com a Hovione. A todas as minhas colegas em todo o mundo, levanto a minha mão: ao trabalhar na Hovione, comprometemo-nos a salvar vidas e a melhorar a qualidade de vida de milhões de pacientes. Não há limite para o que podemos fazer em conjunto. Tenham orgulho. Sejam felizes! Madhu Gautam - Director of Hovione India Hovione India     My name is Camie Lou and I’m the Administrative Manager at Hovione Macau. I am proud to be part of a workplace where everyone is welcomed and so many women have the opportunity to achieve their full potential. I am challenged every day to perform my best and to all my colleagues around the world, I raise my hand: celebrate daily your personal and professional achievements. Let’s celebrate this day together! O meu nome é Camie e sou Administrative Manager na Hovione Macau. Tenho orgulho de fazer parte de uma empresa onde todos são bem-vindos e onde muitas mulheres têm a oportunidade de atingir todo o seu potencial. Sou desafiada todos os dias a dar o meu melhor e para todas as minhas colegas em qualquer parte do mundo levanto a mão: comemorem diariamente as vossas conquistas pessoais e profissionais. Vamos comemorar este dia juntas! Camie Lou - Administrative Manager Hovione Macau     At Hovione Eireann, we are very proud of our diverse and inclusive culture and love to find ways to celebrate it. One aspect of our diversity is our gender balance across our teams and at all levels of the organization and therefore we have again decided to plan an event to celebrate the annual ‘International Women's Day’ on Monday March 8th. We will host a virtual art class, during which we will design a card to send to a woman who inspires us. In keeping with this year’s theme, #choosetochallenge, we are challenging ourselves to try something new and creative, keeping in mind the importance of ensuring everyone on our teams has a voice. This year our event is in aid of Cuanlee, a women's refuge in Cork city which has seen a big increase in calls for help this year due to the lockdowns over the past 12 months. We hope our contribution towards them helps in some way with the challenges they face every day. Na Hovione Irlanda, temos muito orgulho da nossa cultura diversificada e inclusiva e adoramos encontrar formas de a celebrar. Um aspeto da nossa diversidade é o equilíbrio de género nas nossas equipas e em todos os níveis da organização e, por isso, decidimos novamente planear um evento para celebrar o ‘Dia Internacional da Mulher’ na segunda-feira, 8 de março. Faremos uma aula de arte virtual, durante a qual desenharemos um cartão para enviar a uma mulher que nos inspire. De acordo com o tema deste ano, #choosetochallenge, estamos a desafiar-nos para tentar algo novo e criativo, tendo em mente a importância de garantir que todos nas nossas equipas têm uma voz. Este ano, o nosso evento irá apoiar a Cuanlee, um refúgio feminino na cidade de Cork, que teve um grande aumento no número de pedidos de ajuda devido aos confinamentos dos últimos 12 meses. Esperamos que a nossa contribuição as possa ajudar a enfrentar os desafios de todos os dias. Mary Hennessy - Director of Human Resources Ireland Louise Dennehy - HR Business Partner, Linda Cullinane - Supply Chain Director, Sarah Downing - QA Director, Sarah Scott - Product Quality Manager Hovione Ireland     My name is Tânia and I’m an Events Coordinator at Hovione Portugal. In my professional career, I have always achieved my goals, always keeping an attitude based of humility, integrity, and an open mind! Joining Hovione was one of those goals, and it has brought me new experiences, both professionally and personally. O meu nome é Tânia e sou Events Coordinator na Hovione Portugal. No meu percurso profissional, tenho lutado sempre para concretizar as metas a que me proponho, seguindo sempre a minha visão pessoal de humildade, integridade e otimismo! A entrada na Hovione foi uma dessas metas, que me tem trazido novas experiências quer a nível profissional como pessoal. Tânia Dias - Events Coordinator Hovione Portugal     My name is Mafalda and I am a proud scientist at Hovione R&D Portugal. My journey here began six years ago, as an analytical chemist, and evolved to management positions, all within R&D. I am passionate about science, business and people! I truly believe that we can all achieve our goals and pursue our passions, if we truly work for it, independent of gender, race, sexual orientation or religion. The sky is, indeed, the limit! O meu nome é Mafalda e sou uma orgulhosa cientista na Hovione Portugal. A minha viagem começou aqui há seis anos, como analytical chemist, e evoluiu para cargos de gestão, tudo dentro da área de R&D. Sou apaixonada pela ciência, negócios e pessoas! Acredito verdadeiramente que todos podemos alcançar os nossos objetivos e seguir as nossas paixões, se realmente trabalharmos para isso, independentemente do género, raça, orientação sexual ou religião. O céu é, de facto, o limite! Mafalda Paiva - Group Leader, R&D Analytical Development Hovione Portugal     My name is Marilena and I’m an Operational Excellence Engineer at Hovione Portugal. I always thought that to practice cross fit you had to be very strong and a bit crazy. Guess what, I am one of the crazy ones, and all I needed was to step out of my comfort zone, to practice a lot and never give up. O meu nome é Marilena e sou Operational Excellence Engineer na Hovione Portugal. Sempre achei que para praticar cross fit era necessário ser uma pessoa muito forte e louca. Adivinhem, eu sou uma das loucas, e tudo o que eu precisava era sair da minha zona de conforto, praticar muito e nunca desistir. Marilena Ornelas - Operational Excellence Engineer Hovione Portugal     My name is Beatriz and I’m a scientist at Hovione Portugal. From a small town to the capital, from engineering to pharmaceutical development, I feel a sense of accomplishment knowing my everyday small tasks help to save lives. I was lucky to be born in a place where I had all the opportunities available for me, however this is still not the case for so many women all around the world. I will continue to speak up for them.  O meu nome é Beatriz e sou cientista na Hovione Portugal. De uma pequena cidade à capital, da engenharia ao desenvolvimento farmacêutico, sinto-me realizada por saber que as minhas pequenas tarefas diárias ajudam a salvar vidas. Tive a sorte de nascer com todas as oportunidades à minha espera, mas esse ainda não é o caso de muitas mulheres em todo o mundo. Por elas, continuarei a falar. Beatriz Noriega Fernandes - Scientist, R&D DPD Inhalation Hovione Portugal     My name is Sónia and I work at RDP Analytical Sciences at Hovione Portugal. I feel glad to be able to enjoy a fulfilled life by combining the things that I love most: family, science and helping others. O meu nome é Sónia e trabalho na área de RDP Analytical Sciences na Hovione Portugal. Estou feliz por ter uma vida plena ao combinar as coisas que mais amo: família, ciência e ajudar os outros. Sónia Cardoso - RDP Analytical Sciences Hovione Portugal     My name is Marianna and I'm a Scientist at Hovione Portugal. Study hard. Play the cello. Move abroad. Run a half marathon. Explore different cultures. Work hard. Do a headstand. Innovate. Have fun. Change lives. Love. Choose to challenge. The sky is the limit. Women are versatile, support and acknowledge them! O meu nome é Marianna e sou cientista na Hovione Portugal. Estuda muito. Toca violoncelo. Muda de país. Corre uma meia maratona. Explora diferentes culturas. Trabalha no duro. Pratica headstand. Inova. Diverte-te. Muda vidas. Ama. Escolhe desafiar. O céu é o limite. As mulheres são versáteis, vamos apoiá-las e reconhecê-las! Marianna Katz - Scientist – R&D Products Hovione Portugal              


2021 International Women's Day - Read statements

Mar 08, 2021

Guy Villax spoke for the EU API industry at the EU Pharma Strategy Structured Dialogue that the EU Commission launched today. He said: EFCG members make Active Pharmaceutical Ingredients, the core of medicines. The EU has not been in control over its generic medicines for some time – we face frequent shortages and a geostrategic fundamental dependence on APIs and precursors from India and China – where serious accidents, government policies and market failures make us vulnerable.   We have ended up in this untenable situation due to i) unbridled market forces and globalization and ii) 30 years of EU regulations that did not consider that pharma is an intensely globalized and highly competitive industry.  Europe was once the cradle of pharmaceuticals. Today price pressure has driven the generics supply chain to prefer to buy 74% of APIs and precursors from low cost countries with limited regulation. These production locations have low regulatory oversight therefore present higher risk to patient, often cause environmental and antimicrobial resistance because of poor control over wastes, and have a high frequency of deadly accidents – EU industry cannot compete with such low cost operations.   EFCG was founded to level the playing field, this need remains. An EU patient centric pharmaceutical industry needs a EU centric pharma supply chain with a sustainable EU manufacturing base, this requires deliberate and careful regulation to compensate for market forces and to correct the playing field. The US and Japan have already launched countermeasures, we must work with our allies and not independently. European citizens deserve medicines that are Affordable, Accessible and most importantly Available. EFCG knows the issues well and is ready to help, count on us in this partnership. Pierre Luzeau will next list the needed solutions.     The meeting gathered representatives of pharma industry (generics and innovators), patients, hospital pharmacists as well as addressed Minister Marta Temido, MEPs Dolors Montserrat and Nathalie Colin–Oesterlé, Commissaires Kyriakides and Breton, Vice President Schinas.    About the Structured dialogue on Security of Medicines Supply   About EFCG    


Guy Villax spoke for the EU API industry

Feb 26, 2021

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