cGMP compliance
Our facility adheres to current Good Manufacturing Practice, the same standards applied to pharmaceutical manufacturers, including rigorous testing for sterility, potency, and endotoxins.
Our mission
Reliable medications. Real accountability.
We exist to give clinicians, practices, brands, and the patients they serve a manufacturing partner they can actually count on, one with the rigor of large-scale pharma and the responsiveness of a true partner.
Every product that leaves our facility has been built against documented procedures, tested before release, and traced at the lot level. That's not a marketing line. It's the bar we agreed to clear when we built this company, and we don't get to lower it for anyone, on either side of the business.
How we're organized
Two divisions, one standard.
Different audiences, different products, but the same quality system, documentation, and discipline behind everything we make.
503B Outsourcing Facility
For clinicians, practices & health systems
Sterile manufacturing held to the same standards as major pharmaceutical manufacturers, produced under cGMP in ISO-classified cleanrooms and shipped directly to the practices and patients that need them.
- Sterile injectables, ophthalmics, and preparations
- Batch-tested release on every product
- Direct-to-end-user delivery
OTC Division
For retailers, brands & consumers
Over-the-counter and non-sterile product manufacturing: capsules, topicals, and custom oral formulations, produced under the same quality system that governs everything we make.
- Non-sterile capsules, topicals, and troches
- Custom oral and consumer formulations
- Commercial-scale capacity
What sets us apart
Quality is a process, not a claim.
The standards we operate under are the same ones that govern major pharmaceutical manufacturers. Here's how that shows up in practice.
Federal & state oversight
Our facility is subject to FDA inspections and operates in compliance with both federal regulations and the laws of the states we serve.
Quality management
We maintain a robust quality management system with validated processes and thorough batch-level testing before any product is released.
Independent testing
Third-party labs verify potency, sterility, and endotoxin levels before release. We don't grade our own homework.
Cleanroom production
ISO-classified cleanrooms with continuous environmental monitoring and validated processes for every product line.
Lot traceability
Every batch carries documentation back to raw materials, equipment, operators, and conditions. Full chain of custody.
Credentials
Recognized standards. Verifiable practice.
cGMP Compliant
Current Good Manufacturing Practice
FDA Registered
Subject to federal inspection
ISO 9001 Certified
Quality management system
USP Compliant
Compounding standards
In progress
We are actively pursuing the licenses and registrations below. We disclose them up-front rather than waiting for the certificate to land.
503B Outsourcing Facility
Application in progress with FDA
California State License
CA Board of Pharmacy application in review
Who we serve
Built for partners who hold themselves to the same standard.
On the 503B side, we serve clinicians, practices, and health systems that care deeply about where their medications come from. On the OTC side, we serve brands and retailers who need a manufacturer that treats over-the-counter products with the same rigor as a prescription.
Both want the same thing: a partner with the credentials to back up the promise, and the operational discipline to deliver on it every time. If that sounds like you, we'd like to hear from you.
Want to learn more about VictoGen Pharma?
We're happy to walk you through our quality program, capabilities, and onboarding process, for either division.
Contact Us