Peptide News Digest

#Supply-Chain

2 stories

Regulatory · View digest

FDA Warning Letter to Harbin Jixianglong Biotech (May 20): Chinese GLP-1 Supplier Shipped Semaglutide API Sourced From Non-Green-List Facility Under Misleading Label

The FDA sent a warning letter to Harbin Jixianglong Biotech disclosed May 20 after inspectors discovered a compliance failure at the company's manufacturing facility two months after the firm had been added to the FDA's green list to export GLP-1 drugs to the US. Jixianglong allegedly bought semaglutide active pharmaceutical ingredient from a facility not on the green list, labeled the API as manufactured at its own plant (implying the green-listed origin), and shipped the batch to US customers. The FDA framed the labeling as an apparent attempt to circumvent import-alert safeguards. The agency's March 11 enforcement report had previously listed Jixianglong recalls of semaglutide for compounding use only, attributed to failing to complete process validation and bacterial endotoxin method validation before distribution. The action is part of the broader FDA Pharmaceutical Quality / GLP-1 supply-chain enforcement cycle, including the April 30 503B bulks-list proposal closing June 29.

Industry · View digest

BSR Intelligence Peptide Industry Briefing (Mid-May 2026): Compounded Semaglutide Shipments Down 90% YoY, Tirzepatide Down 34%; Counterfeit Purity 5-75%, Lead Levels 10x Safety Limits

UK-based BSR — Biotech Scientific Research — published a peptide industry briefing covering March through early-May 2026 with concrete supply-chain and quality-control data points. Compounded semaglutide shipment volumes are down 90% year-over-year and tirzepatide down 34% as the FDA-declared shortage resolution shifts demand back to branded supply; the April 30 proposal to exclude both drugs from the 503B bulks list continues to compress the compounded segment with comments closing June 29. On the quality side, the briefing cites the 2018 falsification analysis showing research-peptide purity ranging from 5% to 75% with lead concentrations 10x safety limits, plus current evidence of fake Certificates of Analysis from Chinese-sourced products that don't match actual contents. The 'CORE PEPTIDES' scam was flagged January 2026 with documented $500 losses via Cash App and no recourse. 455+ FDA adverse-event reports for compounded semaglutide alone trace back to dosing errors from patients self-administering incorrect doses from multidose vials.