Custom Fine Chemical Manufacturing

Custom Fine Chemical Manufacturing
Product Description

Our comprehensive portfolio of services, integrated manufacturing, and regulatory leadership differentiates us as a leading contract development and manufacturing partner. With a proven ability to deliver solutions to complex challenges, Grace’s FCMS supports the entire small molecule development cycle from the pre-GMP clinical stage through cGMP commercial manufacturing.

From process development through the scale-up of RSMs to complex APIs, we work closely with you to achieve your development goals using the most efficient methods possible.

  • R&D / Analytical Services 
  • Custom APIs 
  • RSMs & Intermediates 
  • Integrated Scale-Up 
In addition to the resources we dedicate to supporting your next breakthrough product, Grace’s FCMS maintains an ongoing program to develop new APIs for several therapeutic indications.

W. R. Grace & Co

  • US
  • 2015
    On CPhI since
Manufacturer/Innovator
Specifications
  • Supplied from
    United States

W. R. Grace & Co

  • US
  • 2015
    On CPhI since
Manufacturer/Innovator

More Products from W. R. Grace & Co

  • Purification and Formulation of Oily APIs and Omega-3s

    Product Purification and Formulation of Oily APIs and Omega-3s

    Grace resins and excipients improve purity and create better targeted and higher value formulations with enhanced bioavailability. Grace is solving purification and formulation issues in oily APIs and Omega-3s in high quality separation capabilities, customization, reliability and speed to market, and compliance - Good Manufacturing Practice (cGMP) guidelines, with EXCiPACT® certification. Most Grace silicas are also patented and listed on the FDA inactive ingredient database.

  • Purification and Formulation of Cannabinoids (CBD)

    Product Purification and Formulation of Cannabinoids (CBD)

    Grace has developed and introduced a patented silica based carrier, SYLOID® XDP silica, to directly convert liquid ingredients such as CBD into solid dosage forms. Extracting and purifying CBD from the hemp plant is a multi-step process which focuses on removal of several undesirable impurities. Grace has a portfolio of products that can help CBD producers not only purify their product but also formulate solid dosage forms that are stable and bioavailable.

  • Drug Delivery for Enhanced Bioavailability of BCS2 (Poorly Soluble) Compounds

    Product Drug Delivery for Enhanced Bioavailability of BCS2 (Poorly Soluble) Compounds

    Engineered to bring together advanced silica technologies with challenging active pharmaceutical ingredients (APIs) to effectively formulate a large class of poorly soluble but otherwise promising compounds, Grace’s SILSOL® silica-based drug delivery technology provides solutions for poorly soluble active ingredients. Combining our expertise in mesoporous silica gel, novel application methods, and patented technologies, SILSOL® silica can provide solutions for acceleration of the screening and development of solubility enhancing solid dispersions, with the added benefit of doing so with compendial, scalable, and available silicas.

  • Custom Bonding and Chromatography Resins for Small and Large Molecule Purification

    Product Custom Bonding and Chromatography Resins for Small and Large Molecule Purification

    A wide range of DAVISIL® silica gel grades are available from one kg to multi-ton quantities to meet your application, performance, and economic requirements. DAVISIL® silicas are used to purify nutraceuticals, antibiotics, vaccine adjuvants, oil-based APIs, organic synthesis products (including intermediates and high-value APIs), and biologics. Compared to other competitor silica gel products, DAVISIL® silicas are available in various pore sizes with higher surface area, lower bulk density, and tighter particle size distribution.

    Produced by a unique process based on purified organosilicate starting materials, VYDAC® spheroidal silicas are well-defined, highly pure, totally porous separation resins for preparative and process scale users. Developed and utilized in applications for protein, peptide, and oligonucleotide separations, VYDAC® resins provide excellent selectivity, reproducibility, and recovery.

    Grace is a pioneer in silica and functionalization technologies, and its scientists continue to develop new and customized solutions beyond our standard range of products, often in close collaboration with customers. Grace’s particle engineering capabilities allow surface, pore, and particle properties to be tuned to meet a customer’s specific requirements. Furthermore, Grace can develop functionalized resins for specific chromatographic applications, including the separation of challenging isomers. Functionalization options include affinity, ion exchange, and reversed / normal phase chemistries. Companies in the nutraceutical and highly regulated pharmaceutical industries have come to depend on the superb quality and performance attributes of Grace silicas.
  • Conversion of Sticky Plant Extracts to Powders

    Product Conversion of Sticky Plant Extracts to Powders

    SYLOID® XDP silica has been specifically engineered to be an optimized carrier for oily liquids that are difficult to handle. The pore structure is designed to carry maximum amounts of oily liquids. The increased density ensures the loaded powder delivers large amounts of liquid in the final tablet or capsule dosage form. SYLOID® silica can be effectively utilized to easily create tablets from viscous natural ingredients.

  • Converting Oily Liquids into Powders and Liquisolids Delivery

    Product Converting Oily Liquids into Powders and Liquisolids Delivery

    NEW: Grace’s SYLOID® XDP mesoporous silica gels are designed to have optimized oil absorption properties, oil desorption rate and density. Thus, oily actives and SEDDS (Self Emulsifying Drug Delivery Systems) can easily be processed into a free-flowing powder that can be further formulated into several oral solid dosage forms (OSDF) like powders, tablets and hard gelatin capsules. These powder dosage formulations can potentially improve stability, bioavailability and patient compliance.

  • Anti-Caking in Powder for Oral Solid Dosage Forms

    Product Anti-Caking in Powder for Oral Solid Dosage Forms

    Whether in bulk or powdered form, keeping food products from caking during processing and storage is critical to providing a quality product to your customer. Usage limits in food applications drive the need for high performance products to prolong shelf life and improve stability. SYLOID® silica enable homogeneous blending with more consistent and uniform fill weight; improve resistance to capping, lamination, and sticking; and adsorb excess moisture from the atmosphere before it can be absorbed by the bulk powder.

  • Oil and Moisture Adsorption in Skincare Applications

    Product Oil and Moisture Adsorption in Skincare Applications

    Grace's portfolio for mesoporous silica includes a range of functional additives that improve processing, achieve desired properties, enhance touch/feeling, or extend the stability and shelf-life of finished products. In topical formulations, the physical characteristics of silica can alter product tactile qualities or enhance other properties such as improving skin-feel and adding film uniformity.

W. R. Grace & Co resources

  • News Grace Completes Acquisition of Fine Chemistry Business

    June 01, 2021: W. R. Grace & Co. announced the completion of its acquisition of the Fine Chemistry Services business (“FCS”) of Albemarle Corporation (NYSE: ALB) for approximately $570 million, including $300 million paid in cash and $270 million funded through the issuance to Albemarle of non-participating preferred equity of a newly created Grace subsidiary.
  • Brochure Grace Pharmaceutical Solutions Brochure

    Learn more about Grace's unmatched quality and reproducibility of our finechemicals, chromatography resins, formulation excipients,and active ingredient delivery technologies.
  • News Grace Expands Global Reach with Major Plant Expansion in Kuantan, Malaysia

    May 20, 2021: W. R. Grace & Co., a global leader in specialty silica, today announced completion of the expansion of its manufacturing plant in Kuantan, Malaysia.
  • Brochure Grace Fine Chemical Manufacturing Services (FCMS) R&D From Concept to Commercial

    Grace Fine Chemical Manufacturing Services (FCMS) has the facilities and expertise to support product development at every stage, from contract research through commercial manufacturing. Having the appropriate resources where you need them, when you need them is critical, and our multiple locations vicand deep experience can help ensure your success.
  • News Grace Doubles LUDOX® Colloidal Silica Capacity with Major European Plant Opening


    June 23rd, 2020: W. R. Grace & Co., a global leader in specialty silica, today announced the opening of its new 8,200 square-meter state-of-the-art, colloidal silica plant at its European flagship manufacturing and R&D center in Worms, Germany.  The facility doubles the worldwide production capacity of LUDOX®, Grace’s leading colloidal silica product, and significantly enhances Grace’s responsiveness to customers in Europe, the Middle East and Africa ...
  • Brochure Converting Oily Liquids into Powders and Liquisolids Delivery

    Grace’s SYLOID® XDP mesoporous silica gels are designed to haveoptimized oil absorption properties, oil desorption rate and density.Thus, oily actives and SEDDS (Self Emulsifying Drug Delivery Systems)can easily be processed into a free-flowing powder that can be furtherformulated into several oral solid dosage forms (OSDF) like powders,tablets and hard gelatin capsules. These powder dosage formulations canpotentially improve stability, bioavailability and patient compliance.
  • Brochure SILSOL® Silica-Based Drug Delivery Technology

    Grace’s SILSOL® silica-based drug delivery technology was engineered to bring together advanced silica technologies with challenging active pharmaceutical ingredients (APIs)to effectively formulate a large class of poorly soluble but otherwise promising compounds. Learn more about SILSOL® silica-based drug delivery technology.
  • Brochure DAVISIL® Chromatographic Silica Solutions

    Discover how DAVISIL® chromatographic silica can provide improved performance, predictable scale-up, exceptional product reliability and provides a greater selection.
  • Brochure Grace Nutraceutical Solutions Brochure

    How much faster could you achieve commercialization by using pharmaceutical-grade products that can be tailored to your specifications to overcome challenges unique to nutraceutical and dietary supplement formulations? Imagine what you could make possible with Grace's Nutraceutical Solutions. Learn more about Grace's Nutraceutical Solutions at marketing.grace.com/nutra.
  • Brochure Grace Silica Technologies for COVID-19 Diagnostic Kits, Vaccine Purification, and Drug Formulations

    Learn how Grace's silica gel portfolio can be included in diagnostic kits, vaccine purification, and tablet and capsule formulations.
  • Video Driving Excipient Innovation

    This session was originally broadcast as part of the CPhI Worldwide 2021 digital content programme. All parties of the pharma supply chain – from manufacturers to patients – want to see the commercialization of innovative products that advance therapeutic treatments. While innovation in the industry remains at the forefront, when it applies to final drug products or boosting API potency, an often-overlooked element is excipients. Excipients play a crucial role in enabling products to achieve desired performance. New ways of delivering, applying, and manufacturing drug compounds are rising thanks to novel excipients. Patients benefit from improved compliance, alternative routes of delivery, upgraded safety profiles, and advancements that are overcoming unmet medical needs. Grace’s broad range of novel excipients accelerate compliance and enhance bioavailability, solubility, and moisture protection. Discover how we are solving many of today’s challenges in drug delivery and formulation.
  • Video Natural Extracts: Unlocking the Potential of Cannabinoid Derived Drugs

    This webinar was originally aired as part of the CPhI Festival of Pharma. The therapeutic benefits of cannabinoids have been hitting the headlines over the past year, and now with a few cannabis-derived or related drug products approved, could the sector be gathering steam? This discussion will examine the current landscape for cannabinoid derived drugs, including looking at pipeline and approvals, development challenges and regulatory hurdles.
  • Video Grace SYLOID®️ Silica Excipients for Pharmaceutical and Nutraceutical Solutions

    race’s SYLOID®️ FP and SYLOID®️ XDP silica excipients are strategic drug development tools in today’s challenging pharmaceutical industry with its demands for improved formulations, bringing new drugs to market faster, and technological advances. Learn more about Grace's SYLOID®️ Silica Excipients for Pharmaceutical and Nutraceutical Solutions at https://marketing.grace.com/pharma-and-nutra-solutions
  • Video Grace DAVISIL®️ Chromatographic Silica for Pharmaceutical and Nutraceutical Solutions

    Imagine what you could do with chromatography products that deliver specificity, recovery, reproducibility,and superior efficiency for the very demanding challenge of separating and purifying unique biological compounds. Learn more about Grace's DAVISIL®️ Chromatographic Silica for Pharmaceutical and Nutraceutical Solutions at https://marketing.grace.com/pharma-and-nutra-solutions

Recommended products