• June 29, 2023

In today’s ever-changing global geopolitical environment, businesses face numerous concerns about their reliance on foreign countries, particularly in East Asia. At Olon USA, we recognize these challenges and are here to help companies navigate the shifting landscape. Our focus is on educating businesses about the capabilities of our pilot facility in the United States and encouraging them to reduce their reliance on foreign countries like China. By bringing their manufacturing processes into the U.S., companies can enjoy greater security and peace of mind while still benefiting from our global presence.

Assuring Timelines and Material Availability

At Olon USA, we understand the importance of timelines and material availability for our clients. With our parent company, Olon, and our network of sites worldwide, we have established reliable channels for sourcing materials. By leveraging our connections in India and Shanghai, we mitigate risks associated with supply chain disruptions. This allows us to secure timelines and ensure that the necessary materials are available for our client’s projects.

Our capabilities at Olon USA extend beyond the initial stages of drug development. In our North American facility, we can handle small to large-scale batches of active pharmaceutical ingredients (APIs), from non-GMP quantities up to 50 to 75 kilograms of GMP API batches. Additionally, our dedicated analytical group supports the entire process, offering method development, validation, and method transfer services. We take a forward-thinking approach, constantly seeking ways to optimize processes for future scale-up, thus enhancing efficiency and cost-effectiveness.

A Vast Global Network of Resources

One of the significant advantages of choosing Olon USA is our extensive global network. With 11 locations worldwide, we have access to a wealth of expertise and resources. Whether it’s regulatory support or seeking advice on unique technical needs, we can tap into the knowledge and capabilities of our diverse sites and corporate Subject Matter Experts. This enables us to address various challenges and ensure the success of our client’s projects.

Our facility in Ohio is designed to cater to clients who prioritize security, peace of mind, and regulatory compliance. Whether our clients are American companies or divisions of foreign companies seeking FDA approval, we offer a seamless experience within the United States. By sourcing starting chemicals sustainably, primarily from India, we enhance business continuity and increase the likelihood of success with regulatory bodies like the FDA. Our comprehensive services include vendor audits, testing of incoming materials, and a rigorous quality assurance process, minimizing the need for remote site visits and ensuring regulatory compliance.

At Olon USA, we continually strive to enhance our capabilities and offer innovative solutions. For instance, our recent acquisition of a high resolution Q-TOF (quadrupole time-of-flight) mass spectrometer allows us to actively identify complex impurities during synthetic processes. This capability ensures compliance with regulatory requirements and assists our clients in assessing potential impurity-related issues.

Taking Action: Transitioning to Olon USA

For those who have already committed their work to less reliable locations, we urge them to take action and explore the benefits of partnering with Olon USA as well as the whole Olon Group. By reaching out to us and sharing their existing synthetic process details, they can swiftly rectify their reliance on uncertain locations. Our team will provide a tailored proposal, and upon choosing to work with us, clients can expect a seamless transition and the assurance of exceptional service and scientific expertise.

When it comes to drug development, navigating global geopolitical challenges and ensuring regulatory compliance are crucial factors for success. Olon USA stands ready to be your trusted partner in these endeavors. By choosing our services, you gain access to a global network of resources, while enjoying the peace of mind and security that comes with having the majority of your project completed in our Ohio facility. Our team of experts is committed to providing exceptional service, scientific expertise, and timely delivery, allowing you to focus on advancing your pharmaceutical innovations. 

Take action today and contact us to explore how Olon USA can propel your drug development programs to new heights of success. Visit our facility, meet our team, and experience firsthand the level of service and commitment we bring to every project. Together, let’s shape the future of pharmaceutical development in the United States.