Grace's Fine Chemical Manufacturing Services (FCMS) is differentiated among many CDMOs in being positioned to supply the entire commercial small molecule drug substance supply chain from domestic U.S. 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.
Through our complementary Michigan, Oregon, and Pennsylvania facilities, Grace's FCMS offers the opportunity to have an integrated domestic supply chain from custom active pharmaceutical ingredients (APIs) to regulatory starting materials (RSMs). There is just one relationship to manage and you have full visibility of your project through all stages of scale-up and manufacturing.
Seamless tech transfer
Our long-tenured teams in Michigan, Oregon and Pennsylvania have worked together for a long time and are experts in drug substance development, scale-up, and manufacturing. Operating three domestic U.S. sites, we can seamlessly tech transfer between each, mitigating risk and optimizing efficiency.
Grace's FCMS offers the ability to reverse-integrate your drug substance supply chain within the U.S. We have demonstrated our capability by helping customers navigate through the registration process in a fast-track regulatory environment. No one else offers a more efficient, integrated supply of custom APIs, RSMs, and intermediates.