HJ
Harbin Jixianglong Biotech Co., Ltd.
Manufacturer · Harbin, China
GMP
Open FDA warning letter 320-26-73 dated 2026-05-01 (CGMP deviations for APIs; misbranded semaglutide); no close-out posted. See the FDA enforcement tracker
Overview
Harbin Jixianglong develops and manufactures peptide APIs and offers formulation and custom peptide services from a 23,000 m2 site in Harbin, founded in 2011. It holds active US Type II DMFs for Carbetocin, Cetrorelix, Eptifibatide, Ganirelix, Octreotide, Oxytocin, Semaglutide, Teriparatide, Terlipressin, Thymalfasin, Tirzepatide. The Heilongjiang provincial drug regulator found its cetrorelix API line compliant with China GMP in 2024. FDA inspected the plant in November 2025 and issued a warning letter on 1 May 2026 citing CGMP deviations and relabeled semaglutide from an unregistered site.
Capabilities
- Peptide API manufacturing
- Custom peptide synthesis
- Formulation technical services
- SPPS and preparative HPLC
Quality signals
| GMP evidence | Yes |
|---|---|
| Certificates of analysis | Not found |
| Third-party testing | Not found |
| ISO certification | Not found |
| Makes own product | Yes, in-house production |