Keeping it Local

Grace’s FCMS has produced fine chemicals in the U.S. for 40 years

The COVID-19 pandemic has revealed the extent to which pharmaceutical companies depend on contract development and manufacturing organizations (CDMOs) in other countries to supply regulatory starting materials (RSMs) and active pharmaceutical ingredients (APIs), as well as to manufacture finished dosage. Widespread sourcing problems continue, including production disruptions, export restrictions, and supply chain issues.

Sourcing materials and manufacturing from facilities around the world is a regular part of doing business. While this approach allows companies to balance access to needed expertise with cost, it also involves trade-offs such as international trade or tariff restrictions. For pharmaceuticals entering the U.S., sourcing internationally often comes with a higher regulatory burden. Products must meet federal safety and regulatory requirements.

With a manufacturing footprint entirely within North America, Grace’s Fine Chemical Manufacturing Services (Grace’s FCMS) can reduce the inherent challenges of international sourcing. 

Experienced domestic manufacturer mitigates supply chain problems and potential regulatory issues

The two fine chemical manufacturing facilities of Grace’s FCMS, both located in the U.S., have been operating for four decades. The facilities produce RSMs and custom reaction intermediates through processes that can scale-up efficiently while meeting regulatory requirements. The firm’s site in South Haven, Michigan, offers CDMO services as well as 13 generic APIs , with all production done under current good manufacturing practices.

The two sites receive crucial materials through a domestic supply chain. Grace’s FCMS strategically developed a North American supply chain years ago to ensure steady access to key raw materials, specialty chemicals, and solvents. Grace’s FCMS also has long-standing relationships with overseas suppliers for basic intermediates.

Supported by a reliable supply chain, deep in-house expertise also keeps production running smoothly at any scale. Scientists and engineers at Grace’s FCMS perform all process development, equipment design, and analytical method development for custom APIs or advanced intermediates. Because Grace’s FCMS does not outsource any R&D or method development work, products move smoothly and quickly through the scale-up process.

Finally, expertise in U.S. and international regulatory requirements, combined with Grace’s FCMS’s strong track record of quality compliance, helps get customers’ products to market quickly. Having employees in U.S.-based facilities also simplifies communication across the country’s time zones so problems can be resolved quickly.

With its integrated U.S. footprint, domestic supply chain, and deep in-house expertise, Grace’s FCMS can mitigate supply chain problems and potential regulatory issues, while delivering high-quality products at any scale.