UP
USV Private Limited
Manufacturer · Mumbai, India
GMP
Open FDA warning letter dated 2026-11-02 (CGMP, Daman finished-dosage facility); no close-out posted. See the FDA enforcement tracker
Overview
USV is a privately held Mumbai pharmaceutical company that makes drug substances and finished products at its own API and formulation plants in eight Indian locations. It holds active US Type II DMFs for Etelcalcetide, Icatibant, Octreotide. FDA inspected its Daman finished-dosage facility in April 2026 and issued a CGMP warning letter on 2 November 2026.
Capabilities
- Peptide APIs
- Small-molecule APIs
- Finished dosage manufacturing
- Biosimilars
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 |