FL
FDC Limited
Manufacturer · Mumbai, India
GMP
Overview
FDC Limited is a Mumbai drugmaker founded in 1936, known for oral rehydration salts and ophthalmics, and is quoted on the NSE and BSE. It runs six plants; its site lists US-FDA accreditation for the Roha API plant and the Waluj plant, UK MHRA for Goa sites and WHO-GMP for Sinnar. The FDA DMF list shows an active Type II DMF for semaglutide filed in 2026, alongside its older small-molecule DMFs.
Capabilities
- Semaglutide API
- API development (Roha)
- Ophthalmics
- Oral solids and ORS
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 |