Serum Institute Of India is a finished-dose manufacturer based in India. It appears in 267 regulatory filings across 20 regulators, without an active US DMF or CEP on file. Its filings concentrate with CDSCO (India), NPRA (MY) and NMRC (NA). Its GMP standing is certified by EMA, ANVISA (Brazil) and MHRA (UK), among 7 authorities. Its most recent recorded inspection, by US FDA, closed on 2 July 2024 as VAI. Customs aggregates show $1.0B of exports covering 4,051 molecules to 165 destinations in 2025.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Pune, United Arab Emirates | Not on file |
| Pune, United Arab Emirates | Not on file |
| Pune, United Arab Emirates | Not on file |
| India, Colombia | Not on file |
| Pune, India | 3020223359 |
| PUNE, India | Not on file |
1 further sites are on record.
| Regulator | Filings | GMP certificates |
|---|---|---|
| CDSCO (India) | 64 | None |
| NPRA (MY) | 23 | None |
| NMRC (NA) | 19 | None |
| TMDA (TZ) | 18 | None |
| UZPHARM (UZ) | 17 | None |
| EFDA (ET) | 15 | None |
| EMA | None | 6 |
| ANVISA (Brazil) | None | 3 |
| MHRA (UK) | None | 2 |
| FDA (GH) | None | 2 |
| NAFDAC (NG) | None | 1 |
| INVIMA (CO) | None | 1 |
| US FDA | None | 1 |
| Year | Revenue | Exports | Destinations |
|---|---|---|---|
| 2026 YTD | Not reported | $183.6M | 121 |
| 2025 | Not reported | $1.0B | 165 |
| 2024 | Not reported | $744.0M | 162 |
| 2023 | Not reported | $830.0M | 160 |
Export figures are customs aggregates. We do not publish the identity of any buyer.
Answered from this company's own record. Where a register holds nothing, the question is not asked rather than answered with a zero. How we count our figures.
Choose your molecules and target markets. Serum Institute Of India comes back tiered against every other supplier able to file there.
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