Synthimed Labs is an API and finished-dose manufacturer based in India. It holds 40 active US drug master files and 19 valid CEPs across a filed portfolio of 26 molecules. Its filings concentrate with AIFA (IT), AEMPS (ES) and ARCSA (EC). Its GMP standing is certified by TMDA (TZ), NAFDAC (NG) and EAEU_EEC, among 6 authorities. Its most recent recorded inspection, by US FDA, closed on 13 March 2020 as NAI. Customs aggregates show $60.6M of exports covering 551 molecules to 56 destinations in 2025.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Mohali, United Arab Emirates | Not on file |
| Derabassi, India | Not on file |
| Mohali, India | 3005895238 |
| Dewas. Madya Pradesh India, Nigeria | Not on file |
| Molecule | Regulators | Docs |
|---|---|---|
| Acamprosate | EDQM, SFDA (Saudi Arabia), US FDA | 4 |
| Atorvastatin | EDQM, US FDA | 4 |
| Clarithromycin | EDQM, US FDA | 4 |
| Fexofenadine | EDQM, SFDA (Saudi Arabia), US FDA | 4 |
| Anastrozole | EDQM, US FDA | 3 |
| Clopidogrel | EDQM | 3 |
| Donepezil | EDQM, US FDA | 3 |
| Letrozole | EDQM, US FDA | 3 |
| Quetiapine | EDQM, US FDA | 3 |
| Ropinirole | EDQM, US FDA | 3 |
| Bempedoic Acid | US FDA | 2 |
| Cinacalcet | US FDA | 2 |
| Eltrombopag | US FDA | 2 |
| Ezetimibe | US FDA | 2 |
| Ibrutinib | US FDA | 2 |
| Mirabegron | US FDA | 2 |
| Nateglinide | US FDA | 2 |
| Pazopanib | US FDA | 2 |
| Pioglitazone | US FDA | 2 |
| Risedronic Acid | US FDA | 2 |
| Temozolomide | US FDA | 2 |
| Clopidogrel Hydrogen Sulfate | EDQM | 1 |
| Fexofenadine Hydrochloride | EDQM | 1 |
| Imatinib Mesilate | EDQM | 1 |
| Risedronate Sodium 2.5-Hydrate | EDQM | 1 |
| Saxagliptin | EDQM | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| AIFA (IT) | 885 | None |
| AEMPS (ES) | 261 | None |
| ARCSA (EC) | 91 | None |
| NAFDAC (NG) | 55 | 2 |
| RCETH (BY) | 51 | None |
| ZAMRA (ZM) | 38 | None |
| TMDA (TZ) | None | 4 |
| EAEU_EEC | None | 2 |
| EMA | None | 1 |
| MCAZ (ZW) | None | 1 |
| GOSPHARMNADZOR (BY) | None | 1 |
| Year | Revenue | Exports | Destinations |
|---|---|---|---|
| 2026 YTD | Not reported | $27.0M | 46 |
| 2025 | Not reported | $60.6M | 56 |
Export figures are customs aggregates. We do not publish the identity of any buyer.
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