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Custom API Manufacturing from a Leading CDMO 

Over 40 years of reliable U.S. supply

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Talk to our experts about how we can help your business. 

Grace’s FCMS has been developing and manufacturing high-value custom APIs for over 40 years and is renowned as one of the market’s consistent, long-standing suppliers across the pharmaceutical and nutraceutical industries. With facilities in South Haven, Michigan, and Tyrone, Pennsylvania, all our API development and manufacturing is done domestically in the U.S., mitigating supply chain risk and optimizing timelines for customers.

Experienced staff

Our personnel across our two U.S. sites have notable long tenures with Grace's FCMS, contributing to the consistency, continuity and experience that bring value to customers. Many of our key team members have been with Grace's FCMS for 15–30 years, which delivers a tremendous depth of know-how and experience with specific processes.

Four decades of manufacturing

South Haven is our cGMP facility with over 40 years of API experience and an excellent compliance record. Grace's FCMS also has a renowned portfolio of generic APIs that were developed during this long legacy and are reliably supplied to companies around the world, highlighting the drug substance expertise at Grace's FCMS.

Available technologies and chemistries

Technology solutions

  • Lithiations
  • Cryogenic processing
  • Liquid ammonia reactions
  • Zirconium reactor / hot caustic
  • Specialty polymerizations
  • Halogenations
  • Ultra-low vacuum distillation
  • Pyrophorics
  • Moisture-sensitive reactions
  • Corrosive & high-temperature distillation


  • Acid chlorides
  • Alkylation
  • Amide formation
  • Bromination
  • Chlorination
  • Condensation
  • Cryogenic reactions
  • Decarboxylation
  • Dehydration
  • Dehydrofluorination
  • Epoxidation
  • Esterification
  • Ether formation
  • Freidel-crafts
  • Grignard
  • Hydrazone formation
  • Hydrogenation
  • Hydrolysis
  • Imine formation
  • Lithiation
  • Nitration
  • Oxidation with peroxide
  • Phosphonation
  • Polymerizations
  • Rearrangements
  • Reduction
  • Sulfonation

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For all Grace product and service inquiries including:

  • Adsorbents
  • Catalysts and Additives
  • Fine Chemicals/Custom Manufacturing
  • Silicas
  • UNIPOL® PP Licensing
  • Safety Data Sheet

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