Concord, Ohio – October 2025 — Olon USA has reached another major milestone in its continued growth and U.S. manufacturing expansion. Following August’s announcement of FDA approval for Aceclidine—a treatment for presbyopia—the company has now received official FDA confirmation, closing the Rotigotine Remote Regulatory Audit (Form 4003) with no observations or further requests.  The Concord site was also recently the subject of an FDA General Surveillance Inspection, also with no observations.

This second approval marks a pivotal moment for Olon USA, which can now proudly state that it holds two commercial API approvals for its Concord manufacturing site and one for its kilo lab.

“We are extremely proud of our team and the hard work that went into both programs—particularly the Rotigotine submission, which required rapid coordination and documentation review,” said Robert Poe, MBA, President and CEO of Olon USA. “These approvals together establish a solid base business for the years ahead and reinforce our position as an FDA-inspected high-quality commercial manufacturer.”

From Development to Commercial Scale

For years, Olon USA has supported small-scale commercial manufacturing through its kilo lab. The recent FDA actions elevate the company’s operational scope, enabling larger-scale production within its current reactor capacities—up to approximately 2,000 liters—while setting the stage for future equipment expansion.

According to Poe, the company is already evaluating the installation of larger reactors to support Phase III and higher-volume commercial programs, extending its capabilities beyond traditional R&D and early clinical production.

Positioned for a Reshoring Era

The timing of these approvals coincides with a significant wave of onshoring and reshoring across the U.S. pharmaceutical industry. With increased scrutiny on global supply chains and a renewed emphasis on domestic manufacturing resilience, Olon USA is well-positioned to meet demand for small-batch or niche API production within the United States.

“There’s a tremendous reshoring opportunity right now,” Poe noted. “We have the space, the commercial experience, and the expertise to serve companies that need to ensure their manufacturing remains within the U.S.”

The company has already completed engineering and feasibility studies for expanding its unused manufacturing bays and maintains a clear timeline and budget for additional build-outs should client demand accelerate.

Inspection Ready, Always

Having undergone extensive preparation—including mock pre-approval inspections and gap assessments conducted by external consultants—Olon USA has established a culture of inspection readiness that aligns with FDA expectations for commercial manufacturers.

Poe emphasized that maintaining this readiness is now a permanent part of operations: “Anytime the FDA visits for surveillance inspections, all aspects of our manufacturing and quality systems are on the table. We plan to stay inspection-ready at all times, and have shown that we are.  As I say to client auditors and FDA inspectors alike, we are glad you are here. When you leave, we know we are doing things correctly, or have some minor areas we need to work on. Our goals align with yours, getting safe medication to patients that need them.”

Looking Ahead

With approvals now in hand and momentum building, Olon USA will update its corporate materials and presentations in the coming weeks to reflect its enhanced regulatory standing and new business opportunities. The company’s leadership team will also be sharing this news during CPhI Worldwide 2025 in Frankfurt, where discussions with potential partners will highlight Olon USA’s expanded capabilities and readiness to support commercial-scale programs.

“This is the perfect next step in our growth,” Poe said. “We’ve moved from an R&D-focused past to a future that includes full commercial manufacturing in addition to our ongoing development expertise. We’re ready to help our partners bring their therapies from concept to market—right here in the United States.”

About Olon USA

Olon USA, located in Concord, Ohio, is part of Olon Group, a global leader in API development and manufacturing headquartered in Milan, Italy. The Concord facility provides chemical synthesis, process development, and commercial API production with a strong focus on quality, regulatory compliance, and technical excellence. Contact us today to get your project started!