FDA PCAC: 7 peptides under review. Read →

Vialdyne

Compounding solutions

Documented for the pharmacist.Aligned to your regulatory framework.

Vialdyne supplies peptide active ingredients to compounding workflows in the U.S. and the EU. Whether you operate as a 503A pharmacy under USP <797> / <800>, a 503B outsourcing facility under FDA registration, or an EU prescription compounder under Annex 1, our per-lot documentation is built around the questions your QA review will ask first.

Audience: Pharmacist-in-Charge

U.S. 503A Pharmacy

Compounding-pharmacy-grade APIs for state-licensed 503A facilities operating under USP <797> / <800>. Every lot ships with the documentation a PIC's QA review will check: COA, endotoxin (LAL), bioburden, residual solvents, water content by Karl Fischer. We track FDA PCAC bulks-list changes and flag affected SKUs on the catalogue.

  • COA with HPLC + MS
  • Endotoxin (LAL) per USP <85>
  • Bioburden per USP <61>
  • ICH Q1A stability data available

Audience: QA Director

U.S. 503B Outsourcing Facility

API supply for FDA-registered 503B outsourcing facilities, with the DMF reference, batch records, and OOS history a 503B QA review typically requests. We coordinate technical-package transfers on signature of a mutual NDA, and supply samples for first-time qualification.

  • FDA DMF reference available
  • Batch records on request
  • OOS / deviation summary (last 3 lots)
  • Sample qualification programme

Audience: Qualified Person (QP)

EU Prescription Compounder

API supply aligned with EU GMP Annex 1 expectations for sterile compounding. CEP-pathway and DMF-on-file products listed individually on the catalogue. Documentation packages include EU-specific stability summaries and import-paperwork support.

  • EU GMP Annex 1 alignment letter
  • CEP / DMF reference per SKU
  • EU stability summary on request
  • Importer-of-record support

Need a lot-data package before your next compounding run?

Send us your catalogue request. We respond with COA samples, an endotoxin / bioburden specification sheet, and an ICH stability summary within one business day for licensed compounders.

Request a Lot Data Package