Kodak Expands Regulated Pharmaceuticals Portfolio
Kodak has announced a significant expansion of its regulated pharmaceuticals portfolio with the launch of four new products designed to meet the stringent requirements of modern research and biopharmaceutical development. The newly introduced offerings include KODAK Phosphate Buffered Saline (PBS) 1X in both low-endotoxin and RNase/DNase/Protease-free formulations, as well as KODAK Water for Injection (WFI) in standard and RNase/DNase/Protease-free grades. All four products are available immediately to research laboratories, biopharma developers, and contract development and manufacturing organizations (CDMOs across the United States.
This portfolio expansion reinforces Kodak’s strategic focus on delivering high-quality, regulated laboratory reagents that support critical applications across pharmaceutical research, biologics development, and advanced manufacturing environments. By broadening its offerings, Kodak aims to provide customers with reliable, compliant solutions that integrate seamlessly into regulated workflows while maintaining the consistency and traceability required by industry standards.
New Product Offerings Strengthen Portfolio
The introduction of the two new PBS formulations builds on Kodak’s existing standard PBS 1X product already available in the market. The new low-endotoxin and RNase/DNase/Protease-free variants are designed to support sensitive applications where contamination control and biological integrity are essential. These formulations are particularly suited for cell culture, molecular biology, and biopharmaceutical processes that demand precise reagent quality and reproducibility.
In addition, the launch of KODAK Water for Injection marks Kodak’s formal entry into the WFI category. Available in both standard and RNase/DNase/Protease-free formats, the WFI products expand customer choice and address a critical need for ultra-pure water in regulated laboratory and pharmaceutical environments. These offerings enable customers to source multiple regulated reagents from a single, trusted supplier, simplifying procurement and quality assurance processes.
Emphasis on Quality, Traceability, and Assurance
All newly launched products are fully lot-traceable and manufactured using Kodak’s rigorous quality systems. Production incorporates a multi-step water purification process engineered to ensure consistent, high-purity output that meets regulatory expectations. This approach supports customer confidence in product performance, batch consistency, and compliance with internal and external audit requirements.
Beyond manufacturing excellence, Kodak emphasizes responsive and personalized customer service as a key differentiator. Customers benefit from direct access to technical expertise, documentation support, and flexible order fulfillment options, reinforcing Kodak’s commitment to long-term partnerships rather than transactional supply relationships.
Strategic Expansion Into Regulated Reagents
The portfolio expansion represents another milestone in Kodak’s broader strategy to evolve from supplying unregulated key starting materials into a leading provider of high-quality Class 1 regulated laboratory reagents. This transition aligns with increasing industry demand for dependable, compliant inputs as pharmaceutical pipelines become more complex and regulatory scrutiny continues to intensify.
Kodak continues to invest in the development of additional regulated pharmaceutical products, leveraging decades of chemical manufacturing expertise and a deep understanding of customer needs across the life sciences ecosystem.
Leadership Perspective on Long-Term Vision
Commenting on the announcement, Jim Continenza, Executive Chairman and Chief Executive Officer of Kodak, described the expanded portfolio as a key step in the company’s long-term growth plan. He emphasized that the new offerings combine Kodak’s legacy of quality with dependable U.S.-based manufacturing and the flexibility to deliver precise formulations and volumes tailored to customer requirements.
According to Continenza, this combination positions Kodak as a trusted partner for organizations seeking reliability, scalability, and regulatory confidence in their supply chains.
Decades of Experience Serving CDMOs
For many years, Kodak has supplied unregulated key starting materials to leading U.S. and multinational CDMOs. This experience is supported by more than 1,400 customer-ready specialty chemical processes, giving Kodak a strong foundation to expand into regulated reagent manufacturing. The company’s established relationships and proven capabilities enable it to meet evolving customer expectations while maintaining operational excellence.
cGMP Facility and Sustainability Focus
Kodak’s pharmaceuticals production operations are housed in a cGMP-compliant facility in Rochester, New York. The site reflects Kodak’s commitment to sustainability through the use of energy-efficient lighting, custom-designed process equipment that reduces greenhouse gas emissions, and a water sterilization system engineered to minimize consumption and waste.
These initiatives align environmental responsibility with operational efficiency, supporting both regulatory compliance and corporate sustainability goals.
Advancing Quality Certifications
To further strengthen its regulatory framework, Kodak is actively pursuing ISO 13485 certification. Achieving this certification will enhance the company’s medical device quality management systems and reinforce its commitment to meeting global regulatory and customer expectations.
About Kodak
Kodak is a global manufacturer focused on commercial print and advanced materials and chemicals, backed by more than 130 years of research and development, a robust patent portfolio, and a customer-first approach, with a strong commitment to innovation, quality, and environmental stewardship.
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