Business Details
Your Trusted Partner in Pharmaceutical Development
Nivagen Pharmaceuticals is a specialty pharma company dedicated to developing, manufacturing, and marketing pharmaceutical products across generics and specialty drugs. Our expertise spans sterile injectables, IV bags, vials, prefilled syringes, cartridges, and ophthalmic formulations, alongside 505(b)(2) drug development and 503B compounding services. We operate a state-of-the-art sterile manufacturing facility in Sacramento, California, with a 100,000 sq ft c-GMP-certified site focused on expanding CDMO services and addressing FDA shortages. Our global network includes manufacturing facilities in Europe and Japan, supported by a team of industry veterans with decades of experience in pharmaceutical innovation.We prioritize integrity, safety, and quality assurance through rigorous testing, regulatory compliance, and continuous improvement. Our leadership team brings deep expertise in sterile manufacturing, drug development, and global supply chain management. We are committed to delivering reliable, cost-effective pharmaceutical solutions to institutional clients worldwide. Our vision is driven by patient needs and defined by uncompromising quality standards. Through strategic partnerships and a focus on innovation, we aim to bridge gaps in drug availability and accessibility. Our operations reflect a culture of accountability, transparency, and long-term value creation.
Services
Drug Product Development
Sterile Manufacturing
CDMO Services
Out Licensing
503B Compounding
Highlights and features
- End-to-end services from drug development to commercialization
- Global manufacturing network with facilities in the USA, Europe, and Japan
- Commitment to quality through rigorous c-GMP compliance and testing
- Leadership team with decades of experience in sterile manufacturing and regulatory strategy
- Focus on addressing FDA drug shortages through scalable production
Associations and certifications
- c-GMP
What people say
Regulatory expertise
Sterile manufacturing excellence
Global partnerships
Experienced leadership
Quality assurance
Services
Drug Product Development
We specialize in end-to-end drug product development for generics and specialty pharmaceuticals. Our expertise includes 505(b)(2) pathways, sterile injectables, and ophthalmic formulations. Our team leverages advanced analytical chemistry and regulatory strategy to translate complex scientific concepts into market-ready products.
Sterile Manufacturing
Our c-GMP-certified sterile manufacturing facility in Sacramento produces IV bags, vials, prefilled syringes, and ophthalmic formulations. We utilize state-of-the-art isolator technology and aseptic processing to ensure patient safety and compliance with global regulatory standards.
CDMO Services
We offer fully integrated CDMO services covering drug development, supply chain management, and regulatory affairs. Our global network includes facilities in Europe and Japan, providing scalable solutions for clinical and commercial manufacturing needs.
Out Licensing
Our CDMO portfolio includes products available for global licensing. We provide customized solutions for out-licensing, including formulation development, regulatory support, and supply chain management to help clients expand their pharmaceutical offerings.
503B Compounding
We deliver FDA-compliant 503B compounding services for institutional clients. Our sterile compounding operations address critical drug shortages while maintaining rigorous quality assurance protocols and adherence to USP standards.
People
Jay Roderick
Head of Manufacturing, Sterile Operations
Seasoned biopharmaceutical executive with 20+ years of leadership experience in sterile manufacturing and regulatory compliance. Previously held key roles at Dendreon, Takeda, and Thermo Fisher Scientific.
Jay Shukla
RPh, MBA
Registered pharmacist with 20+ years of experience in pharmaceutical supply chains and international business. Expertise in sourcing, Medicaid policy, and global market strategy.
Robert Miller
Former CFO
Finance leader with 14 years as CFO at Sonoma Pharmaceuticals and executive roles at GAF Corporation and Merrill Lynch. Stanford and Columbia University graduate with Marine Corps service.
Dr. Dasaradhi Lakkaraju
PhD
Analytical chemistry expert with 24 years in pharmaceutical development. Specializes in solid oral and parenteral formulations, with 24 peer-reviewed publications and patents in formulation development.
Dr. Nirav Patel
Pharmaceutical Executive
Seasoned leader in process development and regulatory strategy with 20+ years in pharmaceutical innovation. Instrumental in launching complex injectables and ophthalmic formulations at Amneal and Baxter.
Questions
What pharmaceutical services does Nivagen offer?
We provide drug development, sterile manufacturing, CDMO services, out-licensing, and 503B compounding for generic and specialty pharmaceuticals.
Where are Nivagen's manufacturing facilities located?
We have facilities in Sacramento, California; Europe; and Japan, with sterile manufacturing expertise across all locations.
How does Nivagen ensure product quality?
We maintain c-GMP certification, rigorous testing protocols, and compliance with global regulatory standards for all our pharmaceutical products.
What is Nivagen's approach to drug shortages?
Our sterile manufacturing expansion focuses on addressing FDA-identified drug shortages through scalable, reliable production capabilities.
