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Nanjing Hanxin Pharmaceutical Technology Co., Ltd.
Manufacturer · Nanjing, China
Open FDA warning letter dated 2026-11-03 (CGMP deviations for APIs, based on a 704(a)(4) records request); no close-out posted. See the FDA enforcement tracker
Overview
Nanjing Hanxin Pharmaceutical Technology was registered in 2017 and makes peptide, protein and polysaccharide APIs and finished products, with API, new-drug and CRO units and a 50,000 m2 GMP production base. It holds active US Type II DMFs for Semaglutide, Tirzepatide (3 DMFs in total). On 3 November 2026 FDA issued a warning letter citing CGMP deviations for APIs, based on records it requested under section 704(a)(4) rather than an on-site inspection.
Capabilities
- Peptide APIs (GLP-1)
- Protein and polysaccharide APIs
- Finished dosage products
- CRO services
Quality signals
| GMP evidence | Not found |
|---|---|
| Certificates of analysis | Not found |
| Third-party testing | Not found |
| ISO certification | Not found |
| Makes own product | Yes, in-house production |