Harbin Jixianglong Biotech logo

Harbin Jixianglong Biotech

China (Harbin) • Manufacturer

Harbin Jixianglong Biotech is a peptide manufacturer based in China (Harbin). Direct manufacturer. Founded 2011. Holds US DMFs for semaglutide, tirzepatide, retatrutide, atosiban and 9 more API.

FDA warning letter
The U.S. FDA sent Harbin Jixianglong Biotech a warning letter dated May 1, 2026 (CGMP for APIs; relabeled semaglutide API from unapproved suppliers). Read the letter on fda.gov. A warning letter is not a court ruling, and companies can respond to it; check fda.gov for any close-out letter.
FDA import alert
The U.S. FDA added Harbin Jixianglong Biotech to Import Alert 66-40 on February 27, 2026 (All drugs and drug products). Drugs from a listed facility can be detained at the US border without physical examination. View the import alert on fda.gov. Firms come off the list once the FDA accepts that the GMP problems are fixed; check fda.gov for the current status.
Official WebsiteReport Discrepancy
Verification Summary
ConfidenceLow
Business TypeManufacturer
ModelManufacturer
RegionAsia
Founded2011
Verification status based on publicly available information and supplier-provided materials.

Listing reviewed October 2026.

Is this your company? Claim this listing to update your info and get a verified badge.Claim This Listing

About Harbin Jixianglong Biotech

Harbin-based maker of peptide APIs, founded in 2011, including semaglutide, tirzepatide, atosiban, terlipressin and carbetocin. The FDA placed it on Import Alert 66-40 on February 27, 2026, removed it from the GLP-1 green list, and issued a warning letter on May 1, 2026 citing quality-unit failures, missing process and cleaning validation, and relabeling semaglutide API from unapproved suppliers under its own name.

Directory assessment: Harbin Jixianglong Biotech is listed as a manufacturer in the peptide supply chain, serving Asia markets from China (Harbin). As a direct manufacturer, this supplier controls its own production process from synthesis through purification and quality control release testing. This profile lists 3 sources for reference. This supplier has a low confidence score because of the open FDA action recorded on this page — check its current FDA status before any transaction.

Products & Categories
Products (2)
peptide APIscustom peptides
Capabilities
Peptide APIsCustom Synthesis
Categories
peptideManufacturingpharmaceutical
Quality & Logistics
In-House Production
Manufacturing & regulatory
US Drug Master Files
  • Atosiban: DMF 39950 (Type II, active), submitted 2024-05-29
  • Carbetocin: DMF 39953 (Type II, active), submitted 2024-05-29
  • Cetrorelix: DMF 39986 (Type II, active), submitted 2024-05-29
  • Eptifibatide: DMF 40034 (Type II, active), submitted 2024-05-30
  • Ganirelix: DMF 39994 (Type II, active), submitted 2024-05-29
  • Octreotide: DMF 39937 (Type II, active), submitted 2024-05-29
  • Oxytocin: DMF 39952 (Type II, active), submitted 2024-05-29
  • Retatrutide: DMF 43846 (Type II, active), submitted 2026-03-14
  • Semaglutide: DMF 39609 (Type II, active), submitted 2024-02-28
  • Teriparatide: DMF 40036 (Type II, active), submitted 2024-05-30
  • Terlipressin: DMF 39987 (Type II, active), submitted 2024-05-29
  • Thymalfasin: DMF 40037 (Type II, active), submitted 2024-05-30
  • Tirzepatide: DMF 39611 (Type II, active), submitted 2024-02-28

DMF numbers from the FDA quarterly DMF list. A filed DMF is not FDA approval; its contents are confidential. Reviewed 2026-10-23.

Listing Sources

Related Suppliers

GL Biochem (Shanghai)
China • Bulk Wholesale
Zhejiang Peptides (ZPC)
China • Bulk Wholesale
Hongzi Peptide
China • Bulk Wholesale
Liyu Daily
China • Bulk Wholesale