What the label states, the lot delivers — net peptide mass, not gross powder weight, purity reported as measured rather than rounded up, and a Certificate of Analysis for every lot.
Net peptide mass, not powder weight; purity as measured, not rounded up; a COA per lot.
Net peptide + purity not rounded up. COA per lot.
FDA PCAC reviews 7 peptides for the 503A bulks list (BPC-157, KPV, TB-500, MOTs-C, Emideltide, Semax, Epitalon). Read our compounder's decision tree. Read our briefing →
FDA PCAC reviews 7 peptides for the 503A bulks list in July. Read →
FDA PCAC: 7 peptides under review. Read →
About Vialdyne
Vialdyne makes vial-ready peptide active ingredients in Shanghai, China and ships them to U.S. 503A / 503B compounding pharmacies, EU prescription compounders, and licensed distributors. Synthesis through QA release runs under one quality system — so the documentation in front of your QA officer comes from the same operation that made the lot.
Our scope
Vialdyne supplies active ingredients to regulated compounding channels and nothing adjacent. We do not sell finished consumer products, we are not a research-only reseller, and we do not list the wellness SKUs that broad peptide catalogs trade on. The narrow scope is the point — it keeps the quality system, the documentation, and the regulatory review pointed at one buyer: the person who has to release our material into a patient preparation.
We are
Vial-ready peptide active ingredients, lot-documented, for 503A / 503B and EU prescription compounding.
We are
State-licensed pharmacies, FDA-registered outsourcing facilities, EU compounders, and licensed distributors — license verified first.
We are not
No consumer storefront, no wellness line, no research-only catalog stacked next to clinical material.
We are not
We invest in documentation depth and regulatory review instead of competing on a low landed price.
From sequence to released vial
Every lot we ship is built end to end inside one Shanghai facility — synthesis, purification, lyophilization, vial filling, and QA release. Nothing arrives as anonymous bulk to be relabeled. That single chain of custody is what lets the documentation map cleanly to the lot in your hand.
Solid-phase build of the target sequence in-house — no outsourced bulk arriving with an unknown history.
Chromatographic purification to the catalog purity target, with the impurity profile captured for the COA.
Freeze-drying to a stable cake, with water content held to the Karl Fischer specification.
Fill and finish under ISO 7 / 8 cleanroom conditions — the vial-ready format a compounder receives.
Per-lot HPLC, mass-spec identity, LAL endotoxin, and microbiology before disposition. QA signs, then the lot ships.
Vial-filling line · 30s walk-through
Stage 04 on the line above — captured on-site during a production day in Shanghai. No stock footage.
Lyophilization
A peptide API is only as good as it is on the day your pharmacist reconstitutes it. We control the freeze-drying step to a defined, stable cake — so a lot ships with the shelf life, transport tolerance, and reconstitution behavior a regulated supply chain can plan around, not a hygroscopic powder that drifts in storage.
Water content to the Karl Fischer limit, lot after lot.
Freeze-dried for the storage and shipping tolerance a regulated chain needs.
A defined cake that behaves the same on your pharmacist's bench every lot.
Release authority
Vialdyne is organized so the people who make material are not the people who release it, and neither one prices it. Inquiries land with Regulatory & Supply, production sits with Manufacturing, and Quality Assurance holds the disposition sign-off that every other function answers to. Each card below states what the function owns and the decision it can block.
Function
Analytical methods, the stability program, batch disposition, and the COA approval workflow. QA is the function that converts a finished batch into a releasable lot.
Can block
Any shipment. No lot leaves the facility without QA sign-off on the analytical packet — purity, identity, endotoxin, water, microbiology.
Draws on
Documented method development (HPLC, mass spec, Karl Fischer, LAL endotoxin) against USP / EP / CP references where applicable.
Function
Synthesis, purification, lyophilization, vial filling, and packaging across the production lines. Final sign-off on the production schedule and any shop-floor change.
Can block
A campaign release if a process deviation is open. Deviations are documented and summarized for buyer audit rather than worked around quietly.
Draws on
Solid-phase peptide synthesis at a major Chinese CDMO; pharma-API process development across research-grade and pharmacy-grade material.
Function
Sequence design, non-standard modifications (PEG conjugation, lipidation, copper coordination, D-amino-acid incorporation, intramolecular disulfide bridging), and pilot-scale process development before a sequence reaches a production line.
Can block
Scale-up of a sequence that has not cleared pilot-scale process validation, so a compounder never receives material from an unproven route.
Draws on
Doctoral-level peptide chemistry; prior custom-sequence work for both research and clinical-development programs.
Function
License verification on every inquiry, regulatory-fit review for the destination market, and the documentation wrapper matched to your filing — 503A, 503B, EU Annex 1, or distributor.
Can block
A quote. Regulatory review reads every inquiry for fit with the destination market's rules before pricing goes out — an unlicensed or ill-fitting request does not get priced.
Draws on
Cross-border peptide-active supply relationships and regulatory tracking across FDA PCAC briefings, EMA scientific advice, and national medicines-agency import frameworks.
Named leaders, photographs, and exact tenure are disclosed under NDA at the supplier-qualification stage, alongside the certificate and audit packet — not on the public site. The avatars above are monogram-style function markers, not photographs; they identify the role, not a specific person.
Supplier history & standing
The manufacturing behind Vialdyne has run since 2013, when the operation started synthesizing peptides for academic labs and CROs and then built outward into the end-to-end production line it runs today. That same facility now supplies regulated compounding channels rather than a research-only customer base — the manufacturing pedigree is long, the positioning is deliberately narrow.
We track the regulatory ground our buyers stand on. The FDA Pharmacy Compounding Advisory Committee review of seven peptides expected in July 2026 — BPC-157, KPV, TB-500, MOTs-C, Emideltide, Semax, and Epitalon — is one we are already aligned with, having matched our documentation depth to what the 503A bulks list will demand.
Who Vialdyne ships to today
Patient-specific compounders operating under USP <797> / <800>, supplied against the documentation a Pharmacist-in-Charge reviews.
FDA-registered outsourcing facilities supplied with the release-data packet and DMF support language a 503B QA review expects.
Magistral and officinal preparers supplied against EU GMP Annex 1 documentation expectations.
Regulated peptide distributors supplied under a Master Supply Agreement with track-and-trace lot data.
Start a qualification
Send us the molecule, your destination market, and your license. Our regulatory team reviews fit before anything is priced. See a real sample COA now — the rest of the lot documentation comes with your inquiry.
First response under 24 hours · Catalog · Sample COA · MOQ · Lead time. Our regulatory and sales teams review every inquiry before pricing — license verification on every request.
