FDA PCAC: 7 peptides under review. Read →

Vialdyne
503A / 503B Aligned · Lot-Documented

Compounding-grade GLP-1 actives,
lot-data documented.

Vialdyne supplies vial-ready peptide APIs to U.S. 503A / 503B compounding pharmacies, EU prescription compounders, and licensed wholesalers — with per-lot COA, LAL endotoxin, and ICH stability data on every shipment.

Download Catalog
Per-lot COA on every shipment
Average response under 12 hours

Lot data · Illustrative

Semaglutide · VD-26-A0517

Passing
HPLC purity
99.62%
USP <621>
Mass-spec identity
Confirmed
ESI-MS · ±0.5 Da
LAL endotoxin
< 0.25 EU/mg
USP <85>
Water content (KF)
≤ 6.0% w/w
USP <921>
CAS 910463-68-2 · MW 4113.6COA on file

34

Active APIs

Global

Shipping

<12h

Response

Manufactured under quality systems · audited annually

ISO 9001:2015
Audited annually
FDA DMF
Type II on file
USP ⟨797⟩
Aligned
EU GMP
Annex 1 aligned
3rd-Party Tested
Each lot

Last audit: May 2026 · Documentation packet on request — info@vialdyne.com

Four Doorways

What buyers come to Vialdyne for.

Four entry points, one quality system. Jump straight to the surface that matches your inquiry — catalog SKUs, compounding-pharmacy fit, regulatory documentation, or the latest editorial brief.

Catalog

90+ vial-ready peptide APIs, lyophilized, lot-coded, ready to ship to licensed compounders.

Browse catalog

Compounding

503A / 503B aligned workflows, USP <797> / <800> aware packaging, EU prescription compounding ready.

See compounding fit

Documentation

Per-lot COA, LAL endotoxin, ICH Q1A stability, FDA DMF on file — full document pack on request.

View documentation

Brief

Editorial briefs on FDA PCAC, EMA Annex 1, USP <797> revisions — written for compounding QA leads.

Read latest brief

Browse by Therapy Area

Compounding-grade peptide actives by clinical-area programme.

Six therapy-area lenses on the same catalog. Pick the clinical programme you formulate against — GLP-1, repair, GH-axis, neuro, immune, or mitochondrial — and drop straight into the matching SKUs.

GLP-1 & Metabolic

GIP / GLP-1 / glucagon agonists for weight, glycemic, and metabolic compounding programmes.

7 SKUs in catalog

Tirzepatide · Retatrutide · Semaglutide · Cagrilintide

Browse

Tissue Repair

Body-protection and actin-binding peptides for tendon, mucosal, and soft-tissue repair workflows.

3 SKUs in catalog

BPC-157 · TB-500 · PEG-MGF

Browse

GH-Axis Peptides

Secretagogues, GHRH analogs, and growth-hormone-axis blends — the deepest slice of the catalog.

11 SKUs in catalog

CJC-1295 (no DAC) · Ipamorelin · Sermorelin · AOD9604

Browse

Cognitive & Neuro

Neuropeptides for cognitive, mood, and sleep research — Semax, Selank, DSIP class on request.

Expanding · custom synthesis on request

Browse

Immune & Anti-Inflammatory

Immune-modulation and antimicrobial peptides — KPV, LL-37 / Thymosin class on request.

1 SKU in catalog

KPV

Browse

Mitochondrial & Longevity

Mitochondrial-targeted peptides and longevity research actives — MOTS-c, SS-31, Epitalon class.

1 SKU in catalog

MOTS-c

Browse

Don't see your programme? Submit a compounding brief — custom synthesis from gram-scale pilot lots through multi-kilogram campaigns.

Regulatory Pedigree

Six citations a QA
director can audit.

Each row below maps one compliance claim to one document Vialdyne can produce on inquiry. We publish the citations, not the marketing.

Full pedigree packet — DMF Letter of Authorization, GMP audit certificate, validation reports — delivered to qualifying buyers under MSA within 12 hours.

Request the regulatory dossier
  1. 01

    cGMP — ICH Q7

    Active pharmaceutical ingredient production runs to ICH Q7 cGMP. Master batch records, change control, deviation logs maintained for every lot.

    21 CFR 211 · ICH Q7
  2. 02

    FDA Drug Master File

    Type II DMF on file. Letter of Authorization issued to qualified compounding pharmacies and 503B outsourcing facilities on request.

    21 CFR 314.420 · Type II
  3. 03

    EU GMP Annex 1 (2022)

    Sterile manufacturing aligned with the 2022 Annex 1 revision. Contamination control strategy documentation available to EU prescription compounders.

    EudraLex Vol 4 · Annex 1
  4. 04

    Endotoxin Limit

    LAL bacterial endotoxin tested every lot, released below 5 EU / mg target. Method validation report on file (kinetic chromogenic).

    USP <85> · LAL
  5. 05

    Stability Programme

    Long-term (25 °C / 60 % RH) and accelerated (40 °C / 75 % RH) stability under ICH Q1A(R2). 12-month minimum dataset for every catalog SKU.

    ICH Q1A(R2)
  6. 06

    USP <797> / <800> Awareness

    API documentation packets match what 503A pharmacies need to file under USP <797> non-sterile and <800> hazardous-drug handling SOPs.

    USP <797> · USP <800>
Vialdyne released-batch vials on the QA bench, lyophilized peptide active inside each, after per-lot HPLC and LAL endotoxin testing

Released-batch vials · Shanghai facility · post-QA hold

Quality You Can Verify

Every batch ships documented.

Every Vialdyne shipment ships with the batch's Certificate of Analysis — HPLC purity, mass-spec identity, LAL endotoxin, water content, residual solvents, and microbial limits. Sequence verification and ICH stability data available on request.

≥99%

Purity by HPLC

100%

Per-batch COA

<12h

Doc response

HPLC + Mass Spec on every batch, analytical methods aligned with USP <1225>.

LAL endotoxin + microbial limits for sterile compounding-pharmacy use.

ICH Q1A stability, accelerated (40°C / 75% RH) + long-term data on request.

View sample COA (PDF)Read about our analytical methods

Compounding Pathways

Four onboarding pathways. Same release standard.

Vialdyne ships to four distinct regulated channels. Each one has its own license-class, documentation set, and onboarding cadence — the lot data is the same, the wrapper is matched to your filing.

U.S. · BOP-licensed

503A Compounding Pharmacy

Bulk-list API supply to 503A patient-specific compounders.

Order pattern
25 g – 500 g per month, repeat lot pattern
Lead time
Stock SKUs: 3–5 business days · custom-pack: 7–10 days

Documentation per lot

  • Per-lot COA · USP / pharmacopeial methods
  • LAL endotoxin certificate (USP <85>)
  • Residual solvents (ICH Q3C class 1–3)
  • Statement-of-Materials matched to USP <797>

Onboarding flow

  1. 01State pharmacy license + DEA registration upload
  2. 02Signed material confidentiality + supply terms
  3. 03First lot — micro-batch (10 g) sample at landed cost
  4. 04Standing-order template + lot-data subscription
503A onboarding kit
U.S. · FDA-registered

503B Outsourcing Facility

GMP-grade API for 503B outsourcing facilities.

Order pattern
500 g – multi-kg per campaign, scheduled batches
Lead time
Scheduled campaign: 6–10 weeks from PO to release

Documentation per lot

  • Per-lot full release-data packet
  • DMF Letter of Authorization on request
  • ICH Q1A(R2) long-term + accelerated stability
  • Process / analytical method validation reports

Onboarding flow

  1. 01FDA registration (21 CFR 207) + state license verification
  2. 02Quality / Master Supply Agreement
  3. 03Pre-production audit (remote video + paper review)
  4. 04First production campaign with on-site QA witness option
503B program brief
EU / EEA · EMA-aligned

EU Prescription Compounder

API supply to EU magistral and officinal preparations.

Order pattern
10 g – 200 g per prescription cycle
Lead time
Stock SKUs: 5–7 business days customs-cleared into EU

Documentation per lot

  • Per-lot COA (Ph. Eur. methods where listed)
  • EU GMP Annex 1 alignment statement
  • TSE / BSE Statement of Compliance
  • Importer dossier (Falsified Medicines Directive)

Onboarding flow

  1. 01Pharmacy license + GDP transport partner confirmation
  2. 02EU-importer GMP licence on file with us
  3. 03First shipment via track-controlled EU corridor
  4. 04Recurring lot-data delivery via PDF + signed XML
EU compounder brief
U.S. / EU / APAC · Wholesale licence

Licensed Wholesaler / Distributor

Inventory pipeline for regulated peptide wholesalers.

Order pattern
Kilogram-scale forward inventory, quarterly cadence
Lead time
Quarterly forecast: 8–12 weeks lead per campaign

Documentation per lot

  • Wholesale supply MSA + indemnification
  • Track-and-trace lot data (DSCSA / FMD ready)
  • Pre-shipment inspection report
  • Stability bridging data for re-test extension

Onboarding flow

  1. 01Wholesale Distributor licence verification
  2. 02Anti-diversion / KYC pack + territory coverage map
  3. 03Confidential price-list under MSA
  4. 04Forward-inventory contract with monthly draw-down
Wholesale supply terms

Most Requested

Top-cited compounding peptides.

The handful of SKUs that show up in 503A and 503B compounding-pharmacy inquiries more than any others — BPC-157 and TB-500 for repair, Tirzepatide and Semaglutide for GLP-1, CJC-1295 for GH-axis, KPV for immune, MOTS-c for mitochondrial. Browse the full catalog for the other 27.

View full catalog (34)

15-mer

BPC-157

≥99.0%

Body Protection Compound 15-mer

CAS
137525-51-0
Vial
2 mg–10 mg
MOQ on requestGet quote →

43-mer

TB-500

≥99.0%

Thymosin β4 fragment

CAS
885340-08-9
Vial
2 mg–10 mg
MOQ on requestGet quote →
Tirzepatide, molecular structure

Tirzepatide

≥99.0%

GIP / GLP-1 dual receptor agonist

CAS
2023788-19-2
Vial
2 mg–120 mg
MOQ on requestGet quote →
Semaglutide, molecular structure

Semaglutide

≥99.0%

GLP-1 receptor agonist

CAS
910463-68-2
Vial
2 mg–50 mg
MOQ on requestGet quote →
CJC-1295 (no DAC), molecular structure

CJC-1295 (no DAC)

≥99.0%

Modified GRF 1-29 · GHRH analog

CAS
863288-34-0
Vial
2 mg–10 mg
MOQ on requestGet quote →

3-mer

KPV

≥99.0%

Lys-Pro-Val α-MSH C-terminal tripeptide

CAS
67727-97-3
Vial
5 mg · 10 mg
MOQ on requestGet quote →

16-mer

MOTS-c

≥99.0%

Mitochondrial-derived peptide

CAS
1627580-64-6
Vial
10 mg–40 mg
MOQ on requestGet quote →

All products are supplied to licensed compounding pharmacies, 503B outsourcing facilities, EU prescription compounders, and licensed wholesalers only. Pricing and MOQ on request.

Filling line · 30s walk-through

Captured on production day · for the full facility walkthrough see our Facility page.

Manufacturing & Capacity

Real lines. Real capacity. Not a trading desk.

Vialdyne runs an end-to-end peptide manufacturing operation in Shanghai, from synthesis and HPLC purification through lyophilization, vial filling, and packaging, across multiple parallel lines under ISO 7/8 cleanroom conditions.

End-to-end

Synthesis · Purification · Lyophilization · Vial filling, all in-house.

ISO 7 / 8

Cleanroom grades for filling and packaging.

Pilot → Commercial

From gram-scale pilot lots to multi-kilogram commercial campaigns.

10 vial / box

Custom packaging, labeling, and inserts available.

See the full facilityDownload catalog (PDF)

Custom Synthesis Programme

From in-vitro to commercial supply,
one quality system.

IND sponsors and NDA holders run a peptide through three regulatory stages. Vialdyne runs each stage under the same cGMP backbone, with scope and documentation tightening as the molecule advances toward commercial supply.

Discuss on WhatsAppinfo@vialdyne.com

Stage 01

Discovery / Preclinical

Gram-scale custom synthesis for in-vitro / in-vivo work.

  • ·Sequence design review (HPLC purity ≥ 95 %)
  • ·5 – 50 g synthesis · single-batch
  • ·Lyophilized peptide + simple COA
  • ·No DMF, no stability programme

Documentation

Research-grade COA · MS / HPLC trace · sequence confirmation

10 – 21 days from purchase order

Stage 02

Clinical Supply · Phase I / II / III

GMP-aligned API for IND-stage clinical batches.

  • ·ICH Q7 cGMP production · master batch record
  • ·100 g – multi-kg per campaign · scheduled
  • ·ICH Q1A(R2) stability programme initiated
  • ·DMF Letter of Authorization for IND sponsor

Documentation

Full release packet · LAL · stability bridging · DMF LOA · CMC section data

60 – 120 days · campaign-scheduled

Stage 03

Commercial Supply

Long-horizon API supply for NDA / MA holders.

  • ·Multi-kg / annual contract scale
  • ·Process validation (3 consecutive successful batches)
  • ·Continuous stability, change-control under QMS
  • ·DMF amendment + commercial supply agreement

Documentation

Full QMS dossier · annual product review · regulatory amendment support

6 – 12 months · multi-year supply contracts

Customer Stories

Procurement workflows that worked.

Anonymized accounts drawn from real Vialdyne engagements, every name, geography, and number removed or rounded, but the procurement structure, timeline, and outcome preserved.

All customer stories
Compounding Pharmacy

US compounding pharmacy switched suppliers mid-cycle and cleared a backlog of GLP-1 prescriptions in 5 weeks

A US Northeast 503A compounding pharmacy was losing patient throughput when its previous bulk-active supplier missed three consecutive lead-time commitments. Switching to Vialdyne against a 6-month forecast cleared the backlog and stabilised the dispensing schedule.

Stockouts in 12 months post-switch

0

Backlog clearance time

~5 weeks

Read the story

Med-Spa / Aesthetic Brand

EU med-spa group launched a private-label GHK-Cu serum line in 11 weeks, end-to-end

A multi-location EU aesthetic-medicine group wanted to launch a retail-friendly anti-aging serum under its existing clinic brand. The OEM workflow took it from signed brief to first commercial shipment in 11 weeks.

Signed brief → first shipment

11 weeks

CPNP notification round-trips

1 (first-review approval)

Read the story

Distributor

Southeast Asian distributor built a region-exclusive GLP-1 inventory line in 4 months

A Southeast Asian aesthetic-medicine distributor wanted to expand from a generalist catalog into a region-exclusive peptide-active distribution channel. Partnership economics and forecast-based inventory took it from initial inquiry to a structured commercial relationship in 4 months.

Inquiry → structured partnership

4 months

SEA markets covered

4

Read the story

Insights & Regulatory

What's moving in peptide sourcing.

Read all insights
Stainless steel vial-capping machine on Vialdyne production line
Regulatory

Published May 16, 2026 · 6 min read

FDA PCAC July 2026: What 7 peptides under review mean for compounders

A buyer's briefing on BPC-157, TB-500, KPV, MOTs-C, Emideltide, Semax, and Epitalon, what changes, what doesn't, and how to prepare your sourcing pipeline.

Read the briefing

Sourcing Guide

BPC-157 sourcing guide for compounding pharmacies

5 min read

Comparison

Tirzepatide vs. Retatrutide: a sourcing comparison

8 min read

Quality

Reading a peptide COA: the buyer's field guide

7 min read

Let's talk peptides.

First response under 12 hours · Catalog · Sample COA · MOQ · Lead time. Our regulatory and sales teams review every inquiry before pricing — license verification on every request.

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