company overview
Have questions about our capabilities? Explore key details about sterile manufacturing, development, analytical, quality, facility, and supply chain support.
faqs
From project planning to packaging, each section provides a clear look at the infrastructure behind our work, giving sponsors a clear view of how we support programs through every step.
Learn more about us, our facilities, and the injectable programs we support.
See how we communicate, manage documentation, and align with clients.
Explore aseptic fill-finish, vial, syringe, and manufacturing capabilities.
Review analytical, microbiology, and stability testing support.
Understand our quality systems, cGMP processes, and compliance framework.
Read about equipment, utilities, and infrastructure that supports operations.
Explore material control, packaging, serialization, and commercial support.
Learn about risk oversight, backup systems, and our operations.
resources + downloads
Looking for more information? Explore our downloadable resources for a closer look at American Injectables’ capabilities, services, facilities, and sterile manufacturing solutions.
Browse the collateral below to learn more about how we support programs from development through commercial supply.
learn more
Connect with our team to discuss specific capabilities.
American Injectables provides clinical and commercial sterile drug product manufacturing services, with capabilities supporting sterile injectable programs from development through commercial supply.
American Injectables operates from 15261 Telcom Dr, in Brooksville, Florida. Our FDA-approved facilities are purpose-built for sterile injectable manufacturing including fill-finish, labs, and package and warehousing.
American Injectables supports sterile injectable drug products, including vial and syringe formats across development, clinical, registration, and commercial stages.
Yes. American Injectables has dedicated analytical laboratory capabilities, supported by a team of scientists focused on formulation, analytical development, stability, and related activities.
American Injectables supports flexible manufacturing scales, including compounding up to 1,000L and vial batch sizes ranging from approximately 1,000 to 150,000 units.
Each project follows a structured lifecycle from business development through formulation and commercialization. Clients are supported by a dedicated project manager who serves as the primary point of contact.
Yes. Each customer project is assigned a project manager to coordinate communication, documentation, timelines, and project activities.
Project meetings are typically scheduled weekly or bi-weekly, depending on client preference and project needs.
Project documentation is organized through shared document systems, trackers, and meeting minutes. Documentation needs are planned early and reviewed with clients throughout the project.
Yes. Client review periods are built into project timelines to support alignment, feedback, and formal approval workflows.
American Injectables’ fully integrated Groninger vial filling line includes:
American Injectables’ fully integrated Optima syringe filling line includes:
Yes. American Injectables uses single-use systems where appropriate, including single-use bags and components for compounding and sterile holding applications.
American Injectables uses Pall Allegro mixing systems with single-use bags and supports compounding scales up to 1,000L.
American Injectables does not currently offer lyophilized formulation services.
Yes. American Injectables has oxygen control capabilities for both dissolved oxygen in solution and vial and syringe headspace management.
Yes. Manufacturing areas include switchable white and amber lighting to support products with light sensitivity requirements.
Yes. American Injectables supports analytical development, method verification, method validation, and stability studies through its internal laboratory capabilities.
Available instrumentation includes HPLC/UPLC, GC, UV-Vis, Karl Fischer, osmometer, density meter, viscometer, FTIR, liquid particle counter, pH meter, CCIT equipment, moisture analyzer, and other analytical systems.
Yes. American Injectables supports stability studies with chambers for standard ICH conditions, as well as photostability capabilities.
American Injectables performs many common parenteral testing activities in-house, including CCIT, endotoxin, bioburden, and other analytical and microbiological testing. Specialized testing may be outsourced to qualified third-party laboratories.
Batch release testing timelines vary by program, but release testing that includes sterility is typically planned around a multi-week timeline.
Yes. American Injectables operates under applicable cGMP requirements, including 21 CFR Parts 210, 211, and 820.
American Injectables maintains a Quality Management System designed to ensure manufacturing processes are performed in accordance with approved procedures, customer requirements, and regulatory standards.
Yes. American Injectables maintains processes for change control, quality events, deviations, CAPAs, batch record review, product disposition, and client notification in accordance with approved quality agreements.
Yes. Batch record review, product disposition, sampling, testing, and documentation review are managed through established quality processes.
Yes. BSE/TSE-free statements can be provided as part of finished drug product disposition documentation when applicable.
Yes. American Injectables maintains internal procedures for method transfer and technical transfer, aligned with applicable ICH guidance.
American Injectables’ facilities support production, stability, in-process operations, warehousing, quality control, microbiology, R&D, and analytical laboratory activities.
Production areas include controlled cleanroom environments ranging from ISO 8 access areas through ISO 5 filling, stoppering, and sealing zones.
American Injectables uses modern filling equipment, including vial filling and syringe/cartridge filling systems, supported by newer or recently installed process equipment.
Equipment validation follows a risk-based approach, including IQ, OQ, and PQ activities. Equipment is supported by calibration, preventive maintenance, and periodic requalification programs.
The site includes water and utility systems that support sterile manufacturing operations, including RODI feeding WFI and clean steam generation, process air, and nitrogen capabilities.
Yes. The facility is supported by backup power systems designed to reduce operational risk during power disruptions.
Yes. American Injectables has refrigerated storage, ambient controlled storage, and stability chamber capacity. Cryogenic storage is not currently offered.
American Injectables maintains a materials management program to support sourcing, handling, storage, shelf-life management, and regulatory compliance.
Yes. Supplier selection, qualification, and ongoing evaluation are managed through a supplier management program designed to support quality, compliance, and supply reliability.
Yes. American Injectables has vendor qualification and approval processes for raw material vendors and other suppliers.
Yes. Supplier and customer change notification processes are in place to support transparency and quality alignment.
Where appropriate, American Injectables can evaluate dual sourcing strategies for high-risk materials, APIs, excipients, and packaging components.
Yes. American Injectables uses an inventory management system to support materials tracking and control.
Labeling and packaging capabilities are part of American Injectables’ planned service expansion, with third-party vendor support available where appropriate.
Serialization capabilities are part of American Injectables planned service expansion, with third-party vendor support available where appropriate.
Yes. American Injectables maintains a business continuity plan that can be reviewed as part of client due diligence.
American Injectables maintains risk management processes, backup power support, supplier controls, and project planning practices to help reduce disruption and support continuity.
Yes. American Injectables can provide standard agreement templates and is open to reviewing sponsor-provided templates when appropriate.
