- Olon USA has received FDA confirmation, closing the Rotigotine Remote Regulatory Audit with no observations, following a recent inspection with the same outcome.
- The company now holds two commercial API approvals for its Concord site and one for its kilo lab.
Olon USA has received U.S. Food and Drug Administration confirmation, closing the Rotigotine Remote Regulatory Audit with no observations or additional requests. This follows a recent FDA General Surveillance Inspection at the Concord site, also completed with no observations. The company now holds two commercial API approvals at its Concord facility and one at its kilo lab.
The approvals build on the company’s earlier announcement in August regarding FDA approval of Aceclidine for presbyopia.
“The submissions required rapid coordination and documentation review. These approvals together establish a solid base business for the years ahead and reinforce our position as an FDA-inspected high-quality commercial manufacturer.”
Robert Poe, President and CEO of Olon USA
Olon USA has historically supported small-scale commercial production through its kilo lab. The latest FDA actions expand its operational scope, enabling larger-scale API manufacturing within its existing reactor capacity of around 2,000 litres. The company is evaluating the installation of larger reactors to support Phase III work and higher-volume commercial programmes.
The company noted that the approvals come at a time when the U.S. pharmaceutical industry is undergoing a shift towards onshoring and reshoring. Poe said there is growing demand for domestic small-batch or niche API manufacturing and that Olon USA has the capacity and experience to meet the needs of clients seeking U.S.-based supply.
The Concord site has also undertaken engineering and feasibility studies for expansion, with clear plans for additional build-outs if required. The company highlighted that maintaining inspection readiness is now an integral part of its operations, supported by internal preparation and external consultancy assessments.
