Albemarle FCS is differentiated among many CDMOs in being positioned to supply the entire small molecule drug substance supply chain from domestic facilities. Even companies who prefer to outsource their APIs domestically often have to manage an overseas supplier of starting materials within their supply chain. This can work successfully but it can also create risk around timelines, not to mention the burden of managing a complex supply chain.
Albemarle’s offering, through our complementary South Haven, Michigan and Tyrone, Pennsylvania facilities, offers the opportunity to have an integrated domestic supply chain from registered starting materials (RSMs) through to custom APIs. So there is just one relationship to manage and you have full visibility of your project through all stages of scale-up and manufacturing.
Our long-tenured teams at South Haven and Tyrone have worked together for a long time and are experts in drug substance development, scale-up and manufacturing. Operating two domestic US sites, we can seamlessly tech transfer from RSM manufacture in Tyrone to cGMP production in South Haven, mitigating risk and optimizing efficiency.
Albemarle offers the ability to reverse-integrate your drug substance supply chain within the U.S. We have demonstrated our capability in helping to navigate customers through the registration process in a fast-track regulatory environment. Nobody else offers a more efficient, integrated supply of RSMs, intermediates, and custom APIs.
Albemarle is very motivated to talk about API, intermediates or RSM projects that you are looking to outsource to a reliable supplier. Click below to submit a contact form.Contact us
View the other pages in this section to gain an understanding of the fully integrated drug substance capabilities offered by Albemarle.
Albemarle has developed some of the industry’s best-known APIs, which are available to developers as our portfolio of quality US-sourced generic products.Learn more