cGMP-Aligned Manufacturing
Vesalius supply chains operate under current Good Manufacturing Practice standards. Production facilities are audited, documented, and inspected on a defined cadence.
Manufactured in theUnited States
How a Vesalius product is made, tested, documented and dispensed, and what each of those steps means for the clinician who prescribes it.
Four Steps, Each Documented
From the bulk manufacturer to the participating pharmacy, each step has its own standards and its own records. Here is what happens at each one, and why it matters.
- 01Origin
Manufactured in the United States
Every Vesalius product begins with a bulk substance made in the United States. Manufacturers that supply bulk drug substances must register their facilities with the FDA under section 510 of the Federal Food, Drug, and Cosmetic Act, and follow Current Good Manufacturing Practice (cGMP).
cGMP governs how a facility is built and run: trained staff, controlled and validated processes, calibrated equipment and a written batch record for every lot, so each lot can be traced back to how and where it was made.
- 02Testing
Identity and Purity
Before a lot is released, samples are tested to confirm two things: that the substance is what the label says it is (identity), and how much of the sample is that substance rather than anything else (purity).
For peptides, identity is commonly confirmed by mass spectrometry and purity measured by high-performance liquid chromatography (HPLC). The results apply to that specific lot, which is why each lot is tested on its own.
- 03Records
Certificate of Analysis
The results are recorded in a certificate of analysis tied to the lot number on the product. A certificate typically lists the product and lot, each test performed, the method used, the specification the lot had to meet and the result.
The certificate stays with the lot record, so the documentation follows the product from release to the pharmacy.*
- 04Access
Dispensed by Participating 503A Pharmacies
Vesalius products reach patients only through participating 503A pharmacies, which prepare and dispense medication against a patient-specific prescription from a licensed prescriber.
Section 503A of the Federal Food, Drug, and Cosmetic Act covers traditional compounding pharmacies. They are licensed and inspected by the state boards of pharmacy where they operate, and the prescribing decision stays with the treating provider.
Please Note
*A certificate of analysis documents the results of testing for a specific lot. It is not evidence of safety or clinical effect.
Built for the Audit. Always.
Every lot, every facility, every shipment is documented. We build the chain of evidence the regulators want to see, before they ask.
Third-Party Verification
Every lot is documented with independent analytical testing, and the results are recorded in a certificate of analysis for that lot.
Chain of Custody
From raw material sourcing to finished dosage form, every step is logged. We do not buy from anonymous brokers, and we do not sell to anonymous resellers.
Jurisdiction-Aware
Regulatory frameworks for peptide therapeutics vary across US, Canada, EU, UAE, and Asia-Pacific. Our distribution is structured to respect each jurisdiction we operate in.
Please Note
“cGMP-aligned” refers to manufacturing partners whose facilities operate under Current Good Manufacturing Practice standards. Vesalius Longevity Labs is not itself an FDA-registered manufacturing facility. All products are sourced from third-party manufacturers and verified by independent analytical testing.
Every Lot, On Record
Each lot is tested and its results recorded in a certificate of analysis before it ships. Lot documentation is handled inside the Vesalius provider account for participating providers, so it is not requested through this website.
The certificate pages shown are an illustrative sample, not a real lot record.