Grace’s Fine Chemical Manufacturing Services (FCMS) has been synonymous with the delivery of high-value APIs and other drug substance materials for over 40 years. Two significant factors have played a major part in this long-term, consistent presence in the pharmaceutical ingredients market – the consistent delivery of our two domestic U.S. facilities, and long, average tenure among our scientific and operational personnel.

Focuses on providing efficient and safe custom cGMP commercialization and manufacturing services for the pharmaceutical industry while also focusing on Grace FCMS’s generic and OTC portfolio. 

Kilo Lab: New GMP kilo lab and up to 100-liter

Pilot Plant: GMP, 50-500 gallon, and glass-lined/alloy

Focuses on providing highly flexible, scalable manufacturing for regulatory starting materials (RSMs), and has the capability to produce non-cGMP pharmaceutical intermediates

Pilot Plant: 50-500 gallon, Glass-lined/alloy, and filters/dyers

Our capabilities match customer needs throughout the product life cycle. From the lab bench to commercial production, we are there to ensure consistent quality, efficiency, and service.

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Learn more about our fine chemical manufacturing capabilities 

Biotechnology companies have a long and broad list of needs when considering working with a CDMO. Discover how Grace's FCMS has specialized in addressing these needs for decades.

When collaborating with a CDMO, the dedicated program team, representatives from analytical services, R&D, engineering, operations, and quality, play a pivotal role providing technical and regulatory support if needed. Discover six important benefits a biotech company should expect from its CDMO interactions.

With so many CDMOs, picking the best manufacturer for a particular drug substance can be challenging. Discover five factors to consider when deciding on an optimal CDMO for small-molecule chemistry.

Controlling impurities during manufacturing is critical to ensuring high-quality, safe therapeutics. To help manage impurities and mitigate risk, discover the benefits of partnering with a CDMO with robust chemistry understanding and extensive manufacturing experience.

For drug sponsors, the task of delivering safe, high-quality, and efficacious therapeutics to patients is paramount, and it takes a village. To achieve this goal, sponsors and their manufacturing partners must continually prioritize impurity control across all stages of development and manufacturing.

Securing the supply chain remains a top priority in the pharmaceutical industry. Discover how partnering with a reputable U.S.-based CDMO, pharmaceutical sponsors can maintain resilient operations and ensure uninterrupted delivery of life-saving medications—regardless of global uncertainties.

Over the past 20 years, ChromaDex has evolved from being an expert in natural products chemistry to one that develops dietary supplements, says founder Frank Jaksch. While looking to take its flagship nutraceutical from lab to production, ChromaDex called Grace's FCMS.

Even though smallpox has been eradicated for more than 40 years, the highly contagious and deadly virus is still a matter of significant national security. With Grace's equipment and expertise, SIGA Technologies was able to manufacture TPOXX^®–the first drug approved by the U.S. Food and Drug Administration  specifically indicated to treat smallpox.

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