☆ Exciting Milestone Achieved at Gaylord Chemical! ☆
November 19th, 2024
We are delighted to announce the successful expansion of our plant’s capacity, a pivotal milestone in our ongoing commitment to innovation, sustainability, and growth. This expansion will enhance our ability to continue serving customers with our high standards of producing sustainable and safer products.
On October 18, we had the honor of hosting a special event to celebrate this achievement. We were privileged to welcome esteemed guests, including representatives from the West Alabama Chamber of Commerce, the Mayor of Tuscaloosa, and representatives from the offices of Senator Katie Britt and Senator Tommy Tuberville. Our CEO Frank Roederer led the event, sharing insights into this significant development and our future vision.
The event highlighted our dedication to excellence and our investment in the community and local economy. We are excited about the opportunities this expansion brings and look forward to continuing our journey of growth, innovation, and sustainability. A heartfelt thank you to all our guests and partners who joined us in celebrating this exciting new chapter for Gaylord Chemical!
Understanding the Value of Excipient Grade in Pharmaceutical Development
October 18th, 2024
At Gaylord Chemical Company, we recognize that excipients are not just passive ingredients; they play a crucial role in the efficacy and safety of drug products. Dr. Nigel Langley, our Global Technical Director, recently highlighted the significance of understanding excipient grades during a panel discussion with Pharmaceutical Technology. As emphasized by Dr. Langley and other industry experts, the correct choice of excipient is vital to ensure patient safety and product reliability.
Excipients often constitute the majority of drug formulations, serving essential functions such as modifying the release of active pharmaceutical ingredients (APIs), enhancing stability, and improving patient compliance. However, the importance ofexcipient grade and quality is sometimes overlooked, leading to potentially severe consequences for patient safety.
The FDA defines an excipient as a drug component that must meet stringent Good Manufacturing Practices (GMP) and comply with relevant pharmacopeia standards. In an increasingly global market, manufacturers must navigate various regulatory landscapes, from the United States Pharmacopeia (USP) to the European Pharmacopoeia (Ph.Eur.). At Gaylord Chemical, we prioritize compliance and quality in our excipient products to meet the diverse needs of our clients.
Dr. Langley pointed out that there has historically been a tendency to treat excipients as commodities, leading to miscommunications between suppliers and users. Effective collaboration and understanding of supply chains are critical in selecting the right excipient grade. We advocate for open communication with our clients to ensure the materials we provide align with their specific applications and regulatory requirements.
Traceability within the excipient supply chain cannot be overstated. As highlighted in the panel discussion, the lack of traceability has led to instances of using incorrect or counterfeit materials. Our commitment to traceability allows us to guarantee the
integrity of our products from the point of manufacture to their use in drug development.
To ensure safety and efficacy, it is crucial to qualify excipient suppliers and understand the functional characteristics of materials used in formulations. With Procipient®, our innovative DMSO excipient, we are dedicated to providing pharmaceutical manufacturers with high-quality materials that have been produced under stringent GMP conditions. This ensures our products consistently meet the necessary specifications for their intended use.
Collaboration between excipient manufacturers and pharmaceutical developers is essential for advancing drug development and ensuring patient safety. Gaylord Chemical is committed to fostering these partnerships to enhance the quality of pharmaceutical products.
For more insights, read the full article by Felicity Thomas in Pharmaceutical Technology Europe here (pages 13-15 on the PDF). If you have any questions about Gaylord Chemical or Procipient®, please don’t hesitate to get in touch with our team for more information, or scan the QR code on page 36 of the PDF.
Gaylord Chemical’s New AgXalt™ Series – Designed and Tested for use in Regulated Agrichemical Applications
June 20th , 2023
Gaylord Chemical Company is proud to announce the launch of AgXalt™ X-100, a safe yet powerful solvent specifically designed and tested for use in regulated agrichemical applications. AgXalt™ X-100 is the culmination of many years of testing and collaboration with regulators to put a safe and highly effective solvent into the hands of ag formulators globally.
In a regulatory climate in which chemical products are evaluated under considerable scrutiny, it is no small task to gain approvals for a new end-use application in agriculture. AgXalt™ X-100’s recent EPA decision regarding its standing under 40 CFR § 180.920 is a true testament to its safety profile and its performance has been clearly demonstrated.
Gaylord develops products that are optimized to meet the needs of highly specialized end-use applications with considerable performance and regulatory requirements and AgXalt™ X-100 is no exception. This product has a safety, regulatory, and performance profile that is unmatched by any solvent in the industry. Importantly, Gaylord has made considerable investments to ensure reliable domestic supply of AgXalt™ X-100 in order to support its large-scale use in Ag. In addition to 100% domestic production, Gaylord is proud to be backward integrated and 100% US sourced for every single raw material used to make AgXalt™ X-100.
This is a proud moment for Gaylord Chemical! We look forward to helping our customers innovate for the future.
World’s first dedicated Nitrogen Tetroxide (N2O4) Facility Completed
February 15th, 2023
Gaylord Chemical Company is proud to announce the successful back-integration into all critical raw materials with the completion of the world’s first dedicated Nitrogen Tetroxide (N2O4) production facility which is located in Tuscaloosa, USA. With this major achievement, Gaylord Chemical Company has full control of the availability and quality of the entire value chain from basic to specialty chemicals.
This substantial investment allows us to serve our DMSO customers with significantly improved product availability and thus considerably greater security of supply. We are the only DMSO producer worldwide that is fully back integrated into N2O4, and is able to control quality and availability from the cradle to grave.
Gaylord Chemical Company employees are to be commended for their work and diligence to develop and build the first and only on-purpose Nitrogen Tetroxide production plant in the world, capable of producing the highest purity N2O4 grades. This is a proud moment for Gaylord Chemical to announce this most recent company achievement which once again demonstrates our commitment as the preeminent producer of DMSO globally.