One Platform
Total Pharmaceutical
Partnership
Abiozen is your all-in-one partner for accelerating pharmaceutical innovation—right here in the U.S. As a cGMP-compliant powerhouse, we unite clinical research, sterile injectable API manufacturing, and custom development under one roof to streamline your path from lab to launch. Through our integrated platforms—CRO360™, CMO+™, and Sterile Injectable API Manufacturing—we deliver unmatched speed, precision, and regulatory confidence. With Abiozen, you’re not just outsourcing services—you’re gaining a strategic partner committed to shaping the future of healthcare and getting life-changing therapies to market, faster.
Our Service Offerings
Explore how our diverse services can meet your unique needs.
Injectable APIs
Working with a high-potency or sterile injectable API? Our experts ensure precision and compliance as you scale for global delivery.
Super Generic APIs
Elevating generics with enhanced performance and global compliance—Abiozen delivers cost-effective, high-purity APIs designed for rapid market entry.
CDMO Services
From formulation to full-scale production, Abiozen delivers end-to-end CDMO solutions with GMP compliance, scientific rigor, and global scalability.
CRO360 Services
Abiozen’s CRO360 delivers end-to-end clinical research services with regulatory precision, and therapeutic expertise to accelerate pharmaceutical innovation.
Analytical Testing
Accelerating Global Drug Development with Precision-Driven, Regulatory-Compliant Analytical Testing Services.
Expertise across the entire drug development lifecycle
IND Enabling Services
Accelerate regulatory filings with expert IND strategies that ensure speed without compromising quality.
Analytical Testing
Comprehensive analytical support delivering purity, potency, and regulatory-ready data.
Process Development
Resolve early-stage challenges with scalable, validation-ready process design.
Clinical Trial Material Production
GMP-compliant CTM manufacturing with full aseptic processing and flexible batch sizes.
Clinical Supply & Logistics
Global distribution with real-time tracking and packaging tailored to trial protocols.
Trial Management & Biostatistics
Adaptive trial execution with real-time data and regulatory-grade statistical insights.
Commercial Scale Manufacturing
Seamless scale-up to high-volume production with automated sterile filling lines.
Technology Transfer
Validated, risk-mitigated process transfer ensuring global compliance and consistency.
Packaging & Serialization
End-to-end packaging with global serialization and multilingual compliance solutions.
Generic API Manufacturing
High-quality, scalable API production with regulatory-aligned synthesis protocols.
Intermediates and RSMs
Reliable supply of key intermediates and starting materials with global reach and control.
Partner With Us
Advantages of partnering with Abiozen
Mission & Vision
Abiozen is dedicated to advancing global health by delivering high-quality pharmaceutical products and services, including injectable APIs, Super Generics, and comprehensive CDMO and CRO solutions. Driven by innovation, precision, and regulatory excellence, we empower pharmaceutical companies to overcome complex challenges and accelerate the delivery of transformative therapies. Our vision is to become the global partner of choice, setting new standards in quality and compliance while making life-saving treatments more accessible through cutting-edge technology, expert talent, and sustainable practices.
Leadership Team
Abiozen’s executive team consists of experienced leaders with deep expertise in clinical research, drug development, and regulatory compliance. They drive the company’s strategic vision and cultivate a culture of innovation and excellence. With comprehensive knowledge of the pharmaceutical value chain, the team guides projects from concept to commercialization. Beyond technical proficiency, they are dedicated to advancing healthcare and maintaining the highest global standards, fostering a results-driven and customer-focused organization.
Global Presence and Reach
Abiozen, headquartered in Illinois, USA, operates globally with strategic offices and manufacturing partnerships across Europe, Asia-Pacific, and the Middle East. This enables the company to deliver localized support and maintain high-quality standards worldwide. With extensive regulatory expertise and successful collaborations with agencies like the USFDA, EMA, TGA, PMDA, and DCGI, Abiozen expedites product approvals across multiple jurisdictions. Its robust global distribution network ensures reliable and efficient market access across North America, Europe, Asia-Pacific, and MENA regions.
Corporate Responsibility
Abiozen is committed to corporate responsibility through environmental stewardship, community engagement, and responsible sourcing. We minimize our environmental impact with sustainable operations, support local communities and education, and uphold ethical standards across our supply chain. These efforts reflect our dedication to balancing business excellence with a lasting positive impact on society and the planet.
Science, Powered by People
Some CDMOs can be impersonal, cold, transactional. Abiozen is different because our people are different. We value innovation and teamwork, problem-solving and perseverance. We also firmly believe in the promise of medicine, and our experts hold themselves accountable as they collaborate with you to bring your molecule to life.
News
Abiozen Unveils State-of-the-Art HPAPI Suite to Advance Oncology Therapeutics
East Rutherford, NJ – October 17, 2024 – Cambrex, a leading global contract development and manufacturing organization (CDMO), today announced that their stability storage business, Q1 Scientific, has opened a new cGMP facility in Durham, North Carolina, expanding its capacity for environmentally controlled stability storage services to the pharmaceutical, medical device
News
Abiozen Unveils State-of-the-Art HPAPI Suite to Advance Oncology Therapeutics
East Rutherford, NJ – October 17, 2024 – Cambrex, a leading global contract development and manufacturing organization (CDMO), today announced that their stability storage business, Q1 Scientific, has opened a new cGMP facility in Durham, North Carolina, expanding its capacity for environmentally controlled stability storage services to the pharmaceutical, medical device