From complex chemistries to regulatory-ready API, we provide precise, tailored solutions that ensure compliance, optimize outcomes, and empower you.
Discover advanced capabilities and specialized equipment, including Hastelloy reactors, all designed to handle demanding chemistries with precision and care. Built-in QA oversight ensures every step meets exacting standards, from scalable production to seamless compliance. We deliver consistent, high-purity results tailored to your goals, with a commitment to quality, safety, and speed.
Benuvia transformed our development process. Their use of Quality by Design blew us away with how quickly and precisely they could produce APIs, delivering a level of purity we had never seen before. With Benuvia, we achieved faster timelines and consistent quality that exceeded our expectations.
Mid-sized Biopharma Client
Director, Research and Development
From custom pathways and accelerated timelines to robust regulatory compliance, our solutions meet your needs:
Benuvia’s advanced API synthesis ensures that every batch meets the highest standards of purity, potency, and performance. By leveraging cutting-edge technologies like specialized reactors, we deliver APIs with unmatched consistency and quality. Whether for clinical trials or large-scale production, our APIs empower your drug development process, giving you a critical edge in safety, efficacy, and market competitiveness.
Every product’s synthesis journey is unique, and Benuvia’s expertise lies in crafting custom pathways to meet your specific requirements. From designing optimal routes for complex molecules to streamlining development for faster results, our tailored approach ensures maximum efficiency and effectiveness. With flexible solutions adapted to your project’s challenges, we turn complexity into precision, helping you achieve your goals seamlessly.
Benuvia’s streamlined API synthesis processes are designed to shorten development timelines without compromising quality. With advanced equipment and proactive problem-solving, we identify and eliminate potential bottlenecks early on. Our focus on precision and compliance ensures that your project progresses on schedule, helping you reach critical milestones faster and stay ahead in a competitive market.
Benuvia’s API synthesis services align with global regulatory standards, providing you with the assurance needed to navigate complex compliance requirements. Our cGMP-compliant processes and thorough documentation meet FDA, EMA, and other international guidelines, ensuring seamless approval. With our expertise, you can trust that your APIs are ready for regulatory scrutiny, saving time and avoiding costly setbacks.
Benuvia’s API synthesis is backed by robust QA systems that verify purity, potency, and compliance at every stage. From in-process controls to final product testing, QA ensures scalability without compromising quality, enabling APIs that meet the stringent demands of regulatory submissions and downstream applications.
From small-scale development to full-scale production, Benuvia’s infrastructure is built to adapt to your needs. Our scalable synthesis capabilities, supported by equipment like Hastelloy reactors, allow for smooth transitions as your project evolves. This flexibility ensures that you can respond to changing demands, whether it’s producing for clinical trials or meeting commercial volumes.
Benuvia’s U.S.-based facilities ensure secure and reliable API production, minimizing risks associated with global supply chains. By handling synthesis locally, we reduce lead times, enhance quality control, and provide a stable source of APIs. This reliability is essential for meeting market demands and maintaining a competitive edge in today’s fast-paced pharmaceutical landscape.
Protecting your intellectual property is at the core of our API synthesis services. Benuvia employs secure data management and strict confidentiality protocols to safeguard your proprietary processes and designs. With our commitment to privacy and security, you can focus on innovation, knowing your IP is protected at every step of the synthesis journey.
Benuvia’s API synthesis maximizes cost savings by integrating efficient processes to reduce waste and optimize resource use. Our expertise in route development further minimizes costs by identifying the most effective pathways for complex molecules. These efficiencies translate into significant savings, allowing you to allocate resources strategically.
Sustainability is woven into Benuvia’s API synthesis processes, with a focus on reducing waste, conserving energy, and using eco-friendly materials. By aligning with green chemistry principles, we deliver high-quality APIs while supporting your commitment to environmental responsibility. This dual focus on quality and sustainability ensures long-term success for your projects.
At Benuvia, we’re more than a trusted CDMO; we’re a partner in innovation, precision, and compliance. Dive into our case studies to see how we’ve helped clients streamline API development, overcome regulatory challenges, and bring high-quality drug products to market with confidence.
Dr. Muthiah Chinnasamy, Vice President of API and Formulation R&D, has over two decades of experience in pharmaceutical R&D and manufacturing. His expertise spans API process development, regulatory compliance, and managing CDMO operations across the globe.
With leadership roles at organizations like Cambrex and Bachem, Muthiah has developed FDA-approved drugs, optimized manufacturing processes, and prepared over 300 business proposals. A Ph.D. in synthetic organic chemistry with international postdoctoral experience, he brings a global perspective to solving complex challenges.
Muthiah is passionate about advancing pharmaceutical innovation and is eager to share his insights, answer your questions, and discuss how Benuvia can support your API and formulation development needs.
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