AL
Apicore LLC (RK Pharma)
CDMO · East Windsor, NJ, USA
GMP
Overview
Apicore LLC, a wholly owned subsidiary of RK Pharma Inc., has provided process R&D and API manufacturing services since 2003. It lists offices in East Windsor, New Jersey and Hyderabad, and plants run by Apicore Pharmaceuticals Pvt Ltd in Vadodara (Gujarat) and Visakhapatnam (Andhra Pradesh). Apicore entities hold active US Type II DMFs for Cetrorelix, Degarelix, Ganirelix, Semaglutide, Tirzepatide, Vosoritide. Its regulatory page says both Indian sites were inspected or accredited by USFDA, Japan's MHLW and India's CDSCO.
Capabilities
- Generic peptide APIs
- Custom synthesis
- Process R&D
- DMF and ANDA support
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 |