Infrastructure for reliable domestic supply

Grace FCMS 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.

Simplified sourcing

Grace FCMS’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 active pharmaceutical ingredients (APIs). There is just one relationship to manage and you have full visibility of your project through all stages of scale-up and manufacturing.

Albermale Fine Chemistry - Teams

Seamless tech transfer

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 U.S. sites, we can seamlessly tech transfer from RSM manufacture in Tyrone to cGMP production in South Haven, mitigating risk and optimizing efficiency.

Reverse integration

Grace FCMS 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.

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Start a new project

Grace FCMS is highly 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.

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Related Capabilities

View the other pages in this section to gain an understanding of the fully integrated drug substance capabilities offered by Grace FCMS.

Generic APIs

Grace FCMS has developed some of the industry’s best-known APIs, which are available to developers as our portfolio of quality U.S.-sourced generic products.

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