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Injectable APIs

Sterile Injectable API Manufacturing with Global Impact

At Abiozen, we specialize in the high-quality production of sterile injectable Active Pharmaceutical Ingredients (APIs) that power critical therapies in oncology, emergency care, and chronic disease management. Backed by our 15,000 sq. ft. state-of-the-art manufacturing facility in Illinois, we combine cutting-edge technology with rigorous global compliance standards—including USFDA, EMA, and ICH—to ensure unmatched quality and safety. Our expertise spans high-potency APIs, rapid synthesis for critical care, and robust regulatory adherence, supporting pharmaceutical innovators worldwide in bringing transformative injectable treatments to market faster and safer.

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sterile injectable drug manufacturing

Powering the Future of Injectables

Injectable APIs Engineered for Global Impact, Speed, and Scalability

Sterile API Production

Abiozen’s sterile API production infrastructure is built to deliver pharmaceutical-grade precision and compliance at every stage. Our ISO Class 5 (Grade A) cleanrooms maintain ultra-low particulate levels, supported by real-time particle and microbial monitoring systems that eliminate contamination risks. Fully automated filling lines accommodate diverse vial formats and deliver consistent dosing accuracy while minimizing human contact. We integrate in-line sterilization technologies, including 0.22-micron filtration and methods such as autoclaving and gamma irradiation, to ensure absolute product purity. All operations are performed under strict regulatory oversight in adherence to USFDA, EMA, and cGMP standards, ensuring every batch is safe, sterile, and ready for global distribution.

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Production Capabilities

At Abiozen, our API manufacturing portfolio is engineered to address the full spectrum of therapeutic needs across global markets. We produce high-purity small molecules using advanced organic synthesis and purification methods, while also supporting biologics and biosimilars through cutting-edge bioreactor systems and downstream processing. Our oncology and critical care APIs include cytotoxic and high-potency actives manufactured in secure, contained environments, with a focus on precision and operator safety. Hormonal and specialty injectables—ranging from peptide therapeutics to rare disease treatments—are handled using advanced particle engineering and encapsulation technologies. Each capability is underpinned by full regulatory traceability, aligning with USFDA, EMA, and ICH standards for both clinical trials and commercial production.

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Lyophilization

Abiozen’s lyophilization capabilities ensure optimal product stability, sterility, and shelf-life for injectable APIs and biologics. Our fully automated freeze-drying systems feature precise control over all phases—freezing, primary drying, and secondary drying—using technologies such as controlled nucleation and deep vacuum regulation to maintain structural integrity. The facility supports both small-batch clinical development and large-scale commercial production with the capacity to process up to 50,000 vials per cycle. Real-time monitoring systems are compliant with 21 CFR Part 11, enabling complete traceability and audit readiness. Analytical support, including Karl Fischer titration, residual solvent testing, and sterility validation, ensures every lyophilized product meets the most stringent international quality and regulatory requirements.

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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.

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Injectable APIs

Sterility Validation: Testing per USP <71> and EP 2.6.1 guarantees the absence of microbial contamination, essential for injectable products.

absence of microbial contamination, essential for injectable products compliance with ICH Q3C guidelines, ensuring safety and purity residual moisture levels below 1%, critical for long-term stability. for HPAPIs, equipped with decontamination protocols and waste management systems to uphold safety and environmental standards. real-time environmental monitoring to guarantee sterility. rapid delivery

Two colleagues in a meeting room discussing financial charts and graphs on a laptop and paper.
Injectable APIs

Residual Solvent Testing: Gas chromatography (GC) confirms compliance with ICH Q3C guidelines, ensuring safety and purity.

compliance with ICH Q3C guidelines, ensuring safety and purity residual moisture levels below 1%, critical for long-term stability. for HPAPIs, equipped with decontamination protocols and waste management systems to uphold safety and environmental standards. real-time environmental monitoring to guarantee sterility. rapid delivery of clinical and commercial batches. (up to 2,000

Two colleagues in a meeting room discussing financial charts and graphs on a laptop and paper.
Injectable APIs

Moisture Content Analysis: Using Karl Fischer titration, we achieve residual moisture levels below 1%, critical for long-term stability.

residual moisture levels below 1%, critical for long-term stability. for HPAPIs, equipped with decontamination protocols and waste management systems to uphold safety and environmental standards. real-time environmental monitoring to guarantee sterility. rapid delivery of clinical and commercial batches. (up to 2,000 L) to eliminate cross-contamination risks and enable flexible manufacturing.

Two colleagues in a meeting room discussing financial charts and graphs on a laptop and paper.
Injectable APIs

Sterility Validation: Testing per USP <71> and EP 2.6.1 guarantees the absence of microbial contamination, essential for injectable products.

absence of microbial contamination, essential for injectable products compliance with ICH Q3C guidelines, ensuring safety and purity residual moisture levels below 1%, critical for long-term stability. for HPAPIs, equipped with decontamination protocols and waste management systems to uphold safety and environmental standards. real-time environmental monitoring to guarantee sterility. rapid delivery

Two colleagues in a meeting room discussing financial charts and graphs on a laptop and paper.
Injectable APIs

Residual Solvent Testing: Gas chromatography (GC) confirms compliance with ICH Q3C guidelines, ensuring safety and purity.

compliance with ICH Q3C guidelines, ensuring safety and purity residual moisture levels below 1%, critical for long-term stability. for HPAPIs, equipped with decontamination protocols and waste management systems to uphold safety and environmental standards. real-time environmental monitoring to guarantee sterility. rapid delivery of clinical and commercial batches. (up to 2,000

Two colleagues in a meeting room discussing financial charts and graphs on a laptop and paper.
Injectable APIs

Sterility Validation: Testing per USP <71> and EP 2.6.1 guarantees the absence of microbial contamination, essential for injectable products.

absence of microbial contamination, essential for injectable products compliance with ICH Q3C guidelines, ensuring safety and purity residual moisture levels below 1%, critical for long-term stability. for HPAPIs, equipped with decontamination protocols and waste management systems to uphold safety and environmental standards. real-time environmental monitoring to guarantee sterility. rapid delivery

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