Manufacturing Commercial Success

American Injectables recently completed commercial production of a critical sterile injectable therapy used in the management of rare metabolic disorders. This achievement represents meaningful progress for both organizations and reflects the continued advancement of our facility, our systems, and our technical workforce. Just five years ago, we began assembling the talent and infrastructure needed to build robust quality systems and operational excellence. Today, our first commercial batch is in the hands of patients across the United States.

Building a Reliable Path from Partnership to Product

Our pharma partner selected American Injectables to provide a U.S.-based manufacturing solution capable of supporting a combination formulation with demanding solubility, stability, and fill-accuracy requirements. The program requires tightly controlled environmental conditions, meticulous aseptic practice, and high-precision filling. The product’s clinical importance increased expectations for quality performance, speed to supply, and regulatory readiness.

Our team worked closely with the sponsor to align technical requirements, timelines, and batch objectives. This collaborative approach established a clear operational framework that supported efficient and successful execution.

A Data-Driven, High-Control Manufacturing Strategy

American Injectables executed a structured manufacturing plan designed to protect product integrity and ensure transparency across every stage. Key elements included:

• Formula management tailored to solubility and stability requirements.
• Tight environmental control during compounding and filling.
• FDA inspection success for sANDA submission
• Continuous cross-functional communication to support timely decisions.
• End-to-end quality oversight from material receipt through final release.

This disciplined approach delivered consistent performance, complete traceability, and strong confidence in batch execution.

Commercial Supply Delivered with Confidence

The completed batch met all predefined specifications and advanced efficiently through inspection, documentation, and final quality release. Highlights include:

• Accurate and repeatable fill volumes across the entire run.
• Robust sterility assurance through demonstrated batch testing and simulation validation
• Verified product integrity throughout each stage.

This successful outcome reinforces the reliability of the American Injectables platform and the strength of our partnerships.

Scaling for the Next Generation of Therapies

This program confirms our ability to support complex sterile injectable products from development readiness through commercial distribution. Our controlled environment, integrated systems, and partner-focused operating model reduce risk, enhance visibility, and accelerate pathways to market.

American Injectables continues to expand capabilities with new high-throughput vial and syringe lines, advanced packaging options, and increased support for client programs. These achievements highlight how coordinated collaboration and disciplined execution translate into meaningful results for patients.

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