Over the last decade, global events—from pandemics to supply chain disruptions—have underscored a critical vulnerability in the U.S. pharmaceutical supply chain: overreliance on foreign manufacturing. As a result, the U.S. government has taken meaningful steps to strengthen domestic production of essential drugs and medical products. One of the most impactful moves? Incentivizing companies to onshore pharmaceutical manufacturing.
The Case for Onshoring
Most active pharmaceutical ingredients (APIs) and generic drug manufacturing still occurs overseas, particularly in countries like China and India. This offshoring trend, while cost-effective, has exposed the U.S. to shortages, quality control risks, and national security concerns.
Onshoring—bringing pharmaceutical manufacturing back to U.S. soil—can help address these challenges by:
- Reducing supply chain disruptions
- Enhancing oversight and quality control
- Creating domestic jobs
- Bolstering national preparedness and security
But for many companies, the financial and logistical challenges of onshoring are significant.
Government Incentives: A Catalyst for Change
To accelerate the shift, federal and state governments have introduced a variety of incentives, including:
- Tax credits for building or upgrading domestic manufacturing facilities
- Grants and funding opportunities through agencies like BARDA and the Department of Health and Human Services
- Regulatory support for rapid scale-up and market entry of domestically produced products
- Public-private partnerships aimed at fostering innovation in manufacturing technology
These incentives not only reduce the financial burden for life sciences companies but also send a clear message: the U.S. is prioritizing a secure, resilient pharmaceutical ecosystem.
EMMA International: Your Onshoring Partner
At EMMA International, we’re uniquely positioned to support companies navigating this transition. Our expert consultants offer end-to-end support, from quality systems and regulatory strategies to compliance readiness and facility validation.
We understand the complexities of building or scaling U.S.-based operations in a highly regulated environment. Our team works closely with clients to ensure that every step of the process meets FDA expectations and aligns with current Good Manufacturing Practices (cGMP).
Looking Ahead
The move to onshore pharmaceutical manufacturing is more than a response to past challenges—it’s a forward-thinking strategy for the future. With strong government backing and the right industry partners, the U.S. is poised to become a leader in high-quality, domestically manufactured pharmaceuticals once again.
If your organization is exploring onshoring or expanding domestic production, EMMA International is here to help turn opportunity into operational success.
Interested in learning more about our onshoring support services? Contact us today to start the conversation.
info@emmainternational.com
248-987-4497
