Superior R&D and process development

With 40+ years of experience and new investment in expanded R&D facilities, the Grace FCMS team is the perfect partner to collaborate on the development of your cGMP pharmaceutical project. From the lab to pilot plant, and all the way through commercial production, we have the technical skills and experience to achieve your goals with optimized speed, efficiency and meeting all compliance requirements.

Easy access to know-how

Not only has Grace FCMS successfully developed hundreds of APIs over many decades, including a portfolio of proprietary generic APIs that we supply today, but we are one of the few in the industry to have consistently integrated development of RSMs domestically with scale-up all the way to commercial API manufacture in U.S. facilities. The easy accessibility of this know-how and capability is the fundamental difference between Grace’s FCMS and other outsourcing options.

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Proven track record of scale-up success

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Seasoned R&D technical group of organic chemists (Ph.D.s), supervising contract service operations across our labs

Custom APIs | API Manufacturing

R&D Expansion

Building on this legacy, Grace has never rested on its laurels. In 2019, Grace FCMS completed a 9,000 sq. ft capacity expansion of our R&D facilities, creating vastly more space for our teams to work on our customer’s projects at lab scale and kilo lab. Our experience and state-of-the-art facilities and equipment will progress your drug substance faster and more efficiently than ever before, providing solutions to development challenges.

Tightly integrated teams

Grace FCMS R&D and analytical teams at South Haven, Michigan and Tyrone, Pennsylvania are able to work together easily, and bring diverse collective knowledge across regulatory starting materials (RSMs), intermediates and active pharmaceutical ingredients (APIs).

Development, testing & validation

At our two facilities, we perform analytical development, stability studies and on-site validation. Our custom R&D group comprises chemists, engineers and analytical professionals dedicated to the advancement of your project.

Robust testing & validation

We can work with your technology or use our extensive resources in chemistry and chemical engineering to develop, test and validate efficient new processes. We subsequently thoroughly test these processes to optimize development time and costs. These are strengths that we are particularly proud of.

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Group in South Haven dedicated to method development and validation for GMP products.

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Process engineering team who work with chemists to translate lab processes into the pilot plant, ensuring seamless technology transfer.

Analytical Services & Equipment

Services

  • Method Development
  • Method Validation
  • Problem Solving
  • Stability Studies
  • Cleaning Studies
  • Impurity Identification
  • Mass Spectrometry
  • Chromatography
  • Thermal Testing
  • Elemental Impurity Analysis
  • Physical Properties

Equipment

  • GC and GC/MS
  • FID, TCD
  • GC Headspace
  • HPLC
  • Variable wavelength
  • Diode Array, ELSD, Refractive Index, CAD detectors
  • Viscosity
  • Brookfield
  • Ubbelohde / oil bath or autoviscometer
  • High resolution UPLC-MS (Q-TOF)
  • Traditional wet chemistry methods, autotitrator

 

  • Coulometric KF
  • XRD
  • DSC
  • Flashpoint, Melting point, Ash, FT-IR, UV, DLS, others
  • TGA/DSC
  • NMR
  • Polarimeter for Chiral Analysis
  • Particle Analysis using Malvern Analyzer
  • IC (Ion Chromatography)
  • ICP-MS with microwave digestion
  • IMS (ion mobility spectrometers)

Contact Us

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.

Learn more