Lactalis

Ingredients

Pharma

9 April 2025

European Pharmaceutical Sovereignty: The Role of Local Excipients

Discover how local excipients like pharmaceutical-grade lactose from Lactalis Ingredients Pharma strengthen European pharmaceutical sovereignty by ensuring reliable, high-quality supply chains.

Ensuring European Pharmaceutical Sovereignty: The Key Role of Local Excipients

The growing need for pharmaceutical sovereignty has become a critical concern for Europe. Recent supply chain disruptions have exposed vulnerabilities in the availability of essential pharmaceutical ingredients, highlighting the importance of local and reliable sources. By ensuring full control over its supply chain, Lactalis Ingredients Pharma plays a key role in strengthening European pharmaceutical independence with pharmaceutical grade lactose locally produced. In this article, we examine the impact of supply chain risks, European initiatives, and how local production contributes to a more secure future.

The Post-Pandemic Reality: Strengthening Europe’s Pharmaceutical Supply Chain

The COVID-19 pandemic exposed Europe’s heavy reliance on global supply chains for critical pharmaceutical ingredients, particularly from China and India. With 40% of finished medicines sold in the EU sourced from third countries and 60–80% of active pharmaceutical ingredients (APIs) manufactured outside of Europe (1), the crisis underscored the continent’s vulnerability to supply disruptions. These challenges led to urgent calls for action at the European level, including the European Commission’s Pharmaceutical Strategy for Europe launched in 2020, which aims to:

  • Ensure patient access to safe, effective, and affordable medicines
  • Strengthen Europe’s pharmaceutical manufacturing capabilities
  • Improve crisis preparedness and supply chain resilience (3)

The French government’s 2024–2027 roadmap further emphasizes the necessity of industrial sovereignty, proposing measures such as strategic stockpiles, localized production incentives, and the Critical Medicines Act at the European level (4). Additionally, in 2025, the EMA (European Medicines Agency) and HMA (Heads of Medicines Agencies) introduced the EMANS 2028 strategy, focusing on reinforcing the resilience of supply chains, leveraging AI for health data, and mitigating antimicrobial resistance (5).

The Risks of Supply Chain Disruptions in Pharmaceuticals

The consequences of pharmaceutical supply chain disruptions are severe, affecting both patients and healthcare systems. 88% of supply shortages lead to treatment interruptions, while 35% result in increased medication errors due to substitutions (2). Critical therapeutic areas impacted include anti-infectives (84% of shortages), nervous system medications (60%), and cardiovascular treatments (56%) (2). The increasing frequency of shortages in Europe, with some countries facing over 600 simultaneous drug shortages in 2023, highlights the urgent need for localized and secure production solutions (2).

In response, the European Shortage Monitoring Platform (ESMP) was launched in February 2025 to provide real-time tracking of pharmaceutical shortages and ensure better coordination between industry stakeholders and regulators (6).

Lactalis Ingredients Pharma: A European Leader in Secure Excipient Supply

According to Maeva Croué, Marketing Manager at Lactalis Ingredients Pharma, “Local sourcing and full supply chain control are essential to securing Europe’s pharmaceutical sovereignty. At Lactalis Ingredients Pharma, we ensure that  our pharmaceutical lactose originates from within our Lactalis group, limiting dependencies and reinforcing reliability of our pharmaceutical grade lactose.

Our role at Lactalis Ingredients Pharma is not just about providing high-quality ingredients but also ensuring a robust and self-sufficient supply chain. By sourcing most of our permeates internally within the Lactalis Group, we limit our dependency on external suppliers and reinforce European pharmaceutical sovereignty.

A Sovereign, Fully Integrated Supply Chain

Unlike some pharmaceutical  excipients suppliers, Lactalis Ingredients Pharma integrates its production within the Lactalis Group, a world expert in lactose crystallization.  The pharmaceutical lactose produced at Retiers is derived from permeates within the Lactalis Group, ensuring local sourcing and complete traceability (6). This integrated model strengthens Europe’s pharmaceutical sovereignty by reducing dependence on external supply chains.

Furthermore, Lactalis Ingredients Pharma maintains full control over its supply chain, as the permeates used for pharmaceutical lactose production at the Retiers site are sourced directly from within the Lactalis Group. This autonomy makes Lactalis Ingredients Pharma a key player in securing the sustainability of its own production.

Resilience and Reliability: A Commitment to Secure Supply

Lactalis Ingredients Pharma’s business model prioritizes the full valorization of dairy by-products, ensuring a sustainable and efficient use of resources. By converting whey permeates and whey  from Lactalis cheese production into dairy ingredients such as pharmaceutical lactose(6), the company maximizes the value of each dairy component while contributing to Europe’s circular bioeconomy.

Moreover, Lactalis adheres to the highest pharmaceutical certification standards, including Ph. Eur., USP-NF, and JP compliance, as well as ISO 9001, FSSC 22000, and EXCiPACT certifications, reinforcing its commitment to quality and safety (6).

Strengthening European Health Sovereignty Through Local Partnerships

According to Maeva Croué, while some European pharmaceutical initiatives emphasize diversification of supply chains, true sovereignty is built on local, integrated, and resilient production networks. Lactalis Ingredients Pharma’s model exemplifies this approach by:

  • Ensuring complete vertical integration from dairy collection to final excipient production
  • Providing 100% European-sourced pharmaceutical lactose, reducing external dependencies
  • Delivering  consistent pharma-grade excipients, meeting stringent global regulatory standards

Pharmaceutical sovereignty is a shared responsibility between policymakers, manufacturers, and industry leaders. By ensuring complete supply chain control and high-quality excipient production, Lactalis Ingredients Pharma supports this crucial movement towards European independence.

To learn more about our pharmaceutical lactose solutions or request a sample, contact our team today. Let’s build a more secure and sustainable pharmaceutical future together.

For more insights into pharmaceutical lactose production in France, explore our related articles:

Meet the Expert: Maeva Croué

Maeva is the Product Manager at Lactalis Ingredients Pharma. With extensive expertise in pharmaceutical excipients and product development, she plays a key role in ensuring the quality, reliability, and innovation of Lactalis’ pharmaceutical lactose solutions. 

Sources

  1. European Parliament Report on Pharmaceutical Dependence – Read more
  2. GPUE Report on Medication Shortages 2023 – Read more
  3. European Commission’s Pharmaceutical Strategy for Europe – Read more
  4. French Government’s 2024–2027 Roadmap on Pharmaceutical Sovereignty – Read more
  5. EMANS 2028 European Medicines Strategy – Read more
  6. European Shortage Monitoring Platform (ESMP) – Read more

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