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Your Needs, Our Services

At 503B-outsourcing-One, we don’t just compound sterile medications — we deliver turnkey solutions tailored to the demands of modern healthcare. Whether you're a hospital, clinic, GPO, or health system, our services are built to meet your exact standards for safety, speed, and scale.

TQIP-Powered.                          TQIP-Driven

Resources & Downloads

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Product List (TQIP compliant)

Sterile compounds, batch sizes, pricing
 

White Cubes

Pitch-Deck

TQIP Guide + COA Explainer

validation details & COA interpretation
 

White Cubes

Acquisition
         Brief

2025 Business Plan

     Facility roadmap, licensing & investment
 

Please let us know if there is info you require but do not see here.

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Resources and Downloads

TQIP

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TQIP

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What is the mission of your company or project?

At 503B Outsourcing One, our mission is to solve one of the most critical and invisible problems in American healthcare: drug shortages. We exist to ensure that no patient is ever turned away, no surgery is ever delayed, and no life is ever put at risk simply because a medication wasn’t available. To achieve this, we’ve built a next-generation FDA-registered 503B outsourcing facility that produces sterile, ready-to-use medications with unmatched speed, quality, and compliance.

Our guiding philosophy is simple yet powerful: Top Quality is Priority (TQIP). This mantra drives every aspect of our operation — from our cleanroom protocols and quality assurance systems, to how we support our clients and scale our infrastructure. We’re committed to setting the new standard for outsourced pharmaceutical manufacturing in the United States. But this mission is more than technical excellence. It’s about creating a supply chain our healthcare system can trust — one that’s fast enough for urgent care, flexible enough for nationwide demand, and compliant enough for FDA scrutiny. By combining regulatory discipline, automation-ready infrastructure, and market-

About Us

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