Active pharmaceutical ingredients (APIs) and excipients form the foundation of modern medicines. APIs are the substances that exert a direct therapeutic action, while excipients, although devoid of pharmacological activity, are essential for the stability, bioavailability, and efficacy of drugs. In an increasingly demanding global context, the availability and quality of these ingredients have become strategic priorities for the pharmaceutical industry.
The challenges associated with their management intertwine with growing regulatory complexity, the need to ensure sustainability, and the drive for innovation. The pandemic and recent geopolitical events have highlighted the vulnerability of supply chains, making a holistic and integrated approach essential to guarantee the continuity and safety of medicines.
The AFI Session in Rimini: an Opportunity for Discussion
The eighteenth session of the AFI Symposium, scheduled in Rimini on June 12, 2025, addresses these critical issues with a multidisciplinary approach. The title of the event, Markets and Criticalities in Managing APIs and Excipients, reflects the desire to explore the challenges and opportunities that characterize the sector. In his introductory presentation, Piero Iamartino highlighted the importance of this opportunity for discussion, emphasizing that the session represents a unique occasion to engage with experts and professionals in the field on highly relevant topics.
Marcello Fumagalli: a Global Overview of API Markets
The session will open with a presentation by Marcello Fumagalli, director of ACPA – Associazione Generica Farmaceutica. Fumagalli will present the key findings of a recent report by the association, based on an analysis conducted on around fifty API manufacturers, evenly distributed between Italy and other strategic hubs in Asia, the United States, Europe, and North America.
The report offers an updated snapshot of the global API market, outlining the criteria adopted by producers to meet the increasingly demanding needs of their customers. Fumagalli will propose a holistic analysis that integrates technological factors, innovation, sustainability, and the complexity of the regulatory landscape. This presentation will be a valuable opportunity to understand how key players are adapting to emerging challenges and evolving market dynamics.
Pierfrancesco Morosini: the Regulatory Proposal Critical Medicine Act
Another key moment of the session will be the presentation by Pierfrancesco Morosini, President of Aschimfarma. His talk will focus on the Critical Medicine Act regulatory proposal, developed by the European Association of Chemical Finance. This regulatory initiative aims to boost the production capacity of APIs in Europe by introducing financial incentives and supporting strategic production initiatives.
Morosini will outline the guiding principles of the proposal and the expected impacts on the sector. His presentation will provide valuable insights into how Europe can strengthen its production autonomy, a crucial topic to address supply fragmentation and ensure healthcare security.
Maurizio Battistini: the Impact of the API Network on Pharmaceutical Stockpiles
The topic of stockpiles and the continuity of supply will be explored by Maurizio Battistini, who will present a study on the impact of API supply networks on medicine stockpiles, highlighting manufacturing issues and the concentration of production sources.
This presentation will provide an overview of the structural vulnerabilities of the supply chain and the possible countermeasures to mitigate the risks associated with shortages or production interruptions. In a global context characterized by logistical and geopolitical tensions, Battistini’s analysis will represent an essential contribution to understanding the strategic levers available to companies and institutions.
Best Practices and Critical Aspects in API Management
The session will continue with the contribution of Ian Moore, representative of IPEC (International Pharmaceutical Excipients Council). With extensive experience in the field, Moore will illustrate how excipient manufacturers are steadily improving their position in the global market through targeted initiatives to ensure quality and safety.
In particular, Moore will present the new guidelines for a formalized risk assessment process, developed by IPEC to enhance the availability and reliability of excipients. His analysis will highlight the strategic role of excipients in the formulation of medicinal products and the importance of rigorous management to ensure high quality standards.
The session will conclude with the contribution of Giuseppina Ialongo from AIFA, who will provide an overview of the issues and challenges related to API management, offering a summary of non-conformities and opportunities for improvement.
An Invitation to Dialogue and Innovation
As Piero Iamartino highlighted in his presentation, the eighteenth session of the AFI Symposium represents a valuable opportunity for all players in the pharmaceutical supply chain: API manufacturers, excipient suppliers, pharmaceutical companies, and industry professionals. The invitation to participate is extended to anyone interested in exploring critical and strategic topics that, now more than ever, represent both challenges and opportunities for the pharmaceutical industry.
