Sandoz is an API and finished-dose manufacturer based in Austria. It holds 17 active US drug master files and 20 valid CEPs across a filed portfolio of 28 molecules. Its filings concentrate with AIFA (IT), FAMHP (BE) and EMA. Its GMP standing is certified by EMA, MHRA (UK) and ANSM (FR), among 9 authorities. Its most recent recorded inspection, by US FDA, closed on 2 July 2024 as VAI. Customs aggregates show $188.6M of exports covering 2,928 molecules to 48 destinations in 2025.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Kundl, United Arab Emirates | Not on file |
| Kundl, United Arab Emirates | Not on file |
| KUNDL, Austria | Not on file |
| Vienna, Austria | Not on file |
| Austria, Austria | 3002806523 |
| Niederoesterreich, Austria | Not on file |
6 further sites are on record.
| Molecule | Regulators | Docs |
|---|---|---|
| Cefpodoxime Proxetil | EDQM, SFDA (Saudi Arabia) | 3 |
| Ceftriaxone | EDQM, US FDA | 3 |
| Amoxicillin Sodium | EDQM | 2 |
| Ampicillin | US FDA | 2 |
| Ampicillin Sodium | EDQM | 2 |
| Benzylpenicillin | EDQM, US FDA | 2 |
| Benzylpenicillin (Procaine) Monohydrate | EDQM | 2 |
| Cefazolin | EDQM, US FDA | 2 |
| Cefixime | EDQM, US FDA | 2 |
| Ceftazidime | EDQM, US FDA | 2 |
| Amoxicillin | US FDA | 1 |
| Amoxicillin Trihydrate | EDQM | 1 |
| Benzylpenicillin (Benzathine) Tetrahydrate | EDQM | 1 |
| Benzylpenicillin Sodium | EDQM | 1 |
| Cefdinir | US FDA | 1 |
| Cefotaxime | US FDA | 1 |
| Cefpodoxime | US FDA | 1 |
| Ceftazidime Pentahydrate With Sodium Carbonate For Injection | EDQM | 1 |
| Cephalosporin C | US FDA | 1 |
| Clofazimine | US FDA | 1 |
| Heparin Sodium | US FDA | 1 |
| Levothyroxine | US FDA | 1 |
| Levothyroxine Sodium | EDQM | 1 |
| Phenoxymethylpenicillin | US FDA | 1 |
| Phenoxymethylpenicillin (Benzathine) Tetrahydrate | EDQM | 1 |
| Phenoxymethylpenicillin Potassium | EDQM | 1 |
| Quetiapine | SFDA (Saudi Arabia) | 1 |
| Temsirolimus | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| AIFA (IT) | 1,170 | None |
| FAMHP (BE) | 1,022 | None |
| EMA | 722 | 14 |
| MHRA (UK) | 716 | 3 |
| US FDA | 686 | 2 |
| ANSM (FR) | 583 | 3 |
| MFDS (Korea) | None | 2 |
| NCELS (KZ) | None | 2 |
| ANVISA (Brazil) | None | 2 |
| EAEU_EEC | None | 2 |
| NAFDAC (NG) | None | 1 |
| Year | Revenue | Exports | Destinations |
|---|---|---|---|
| 2026 YTD | Not reported | $16.5M | 30 |
| 2025 | Not reported | $188.6M | 48 |
| 2024 | Not reported | $159.7M | 52 |
| 2023 | Not reported | $179.2M | 54 |
Export figures are customs aggregates. We do not publish the identity of any buyer.
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