Integrated domestic U.S. drug substance supply

As a specialist in small molecule drug substance for more than 40 years, Grace FCMS supplies registered starting materials (RSMs) and intermediates as well as custom active pharmaceutical ingredients (APIs). What separates Grace FCMS from other suppliers is the fact that we develop and manufacture our products at domestic U.S. facilities.

Efficient scale-up

We have all the technology needed to manufacture, scale-up and supply high-quality RSMs and intermediates from our Tyrone, Pennsylvania facility. This does not require cGMP certification; however, South Haven provides uniform quality assurance across both sites, and Tyrone develops these materials efficiently under a quality management system aligned to meet FDA and ICH requirements.

Cryogenic Chemistry

We offer a very wide range of chemistries serving small molecule APIs, including some special capabilities such as cryogenic reactions. Some of the chemical transformations demanded by today’s complex therapeutic drugs require cGMP manufacturing in cryogenic conditions, which in pharmaceuticals refers to temperatures below –80ºC.

Grace FCMS has the capability to run processes at cryogenic conditions of –90ºC, which helps to eradicate impurities, handle highly reactive compounds, improve reaction selectivity, mitigate unwanted secondary reactions, limit volatility for greater safety, and prevent ice crystals. Processes that run under these conditions are sensitive; it is experience and know-how that differentiates Grace FCMS and brings value to our customers.

Ultra-Low Vacuum Technology

Grace FCMS also offers the capability with ultra-low vacuum technology to go to 1mmHg or less on a fractional distillation, enabling the separation of components at lower temperatures and pressure.

RSMs - Drug substance program | CMO Company

Risk Mitigation

The benefit for U.S. companies outsourcing their drug substance program is mitigation of the risks involved in sourcing RSMs overseas, even if their APIs are manufactured domestically. With Grace FCMS, you can maintain a single domestic project management relationship and supply chain, with visibility all the way from production of starting materials to the custom API, and seamless, efficient tech transfers between our Tyrone and South Haven sites.

Secure Supply Chain

The trend for some time has been for RSMs and fine chemicals to increasingly be outsourced to other global regions, but with changing perspectives on areas such as supply chain risk and tariffs, companies are rethinking their strategy, and Grace FCMS provides a very appealing domestic source of supply.

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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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