Bringing Proven European Technology to the U.S. Market 
Ursatec GmbH and Aero Pump GmbH, providers of preservative-free drug delivery systems, are taking a step in expanding their successful European technology into the US pharmaceutical market. Dr. Andreas Bilstein, General Manager, Ursatec, outlined the companies’ strategy at the DCAT Member Company Announcement Forum at DCAT Week.  

To successfully enter and scale operations in the US, Ursatec and Aero Pump’s strategy is based on four key pillars: 

Manufacturing & Supply Chain Development 

• Establishing or partnering with a US.-based production facility to ensure local availability. 

• Strengthening the supply chain to support long-term market demand. 

Regulatory Expertise & Compliance 

• Building a dedicated team to navigate the approval processes by the US Food and Drug Administration 

• Accelerating time-to-market for new preservative-free products. 

Product Portfolio Adaptation 

• Expanding the range of nasal sprays, ophthalmic solutions, oral, and dermal drug delivery systems. 

• Tailoring formulations and delivery systems to meet US regulatory and market requirements. 

Collaboration with US Pharmaceutical Partners 

• Partnering with pharmaceutical manufacturers to integrate preservative-free solutions into their portfolios. 

• Offering innovative drug delivery technologies to enhance patient safety and compliance. 

To support this strategic expansion, Ursaetc and Aero Pump have committed to an  investment of $10 million to $15 million in the initial phase: 

• US filling site establishment: $7-12 million. 

• R&D and market introduction: Up to $3 million. 

• Long-term Device Manufacturing Scale-up: $100 million. 

The companies have set a clear implementation timeline: 

• 2025: Launch of the first preservative-free products in the US market. 

• 2026: Expansion of the product portfolio and establishment of a US-based filling site. 

• 2028: Full-scale manufacturing of finished dosage forms in the US