Unichem Laboratories is an API and finished-dose manufacturer based in India. It holds 29 valid CEPs across a filed portfolio of 29 molecules. Its filings concentrate with TMDA (TZ), MCAZ (ZW) and ZAMRA (ZM). Its GMP standing is certified by EMA, MHRA (UK) and US FDA, among 6 authorities. Its most recent recorded inspection, by US FDA, closed on 2 February 2026 as VAI. Customs aggregates show $188.4M of exports covering 4,657 molecules to 68 destinations in 2025.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Mumbai, India | Not on file |
| HIMACHAL PRADESH, India | Not on file |
| GOA, India | Not on file |
| Kolhapur, India | 3013585679 |
| Dhar, India | 3006456888 |
| Ghaziabad, India | 3004082076 |
4 further sites are on record.
| Molecule | Regulators | Docs |
|---|---|---|
| Hydrochlorothiazide | EDQM, SFDA (Saudi Arabia) | 3 |
| Alfuzosin | EDQM, SFDA (Saudi Arabia) | 2 |
| Bisoprolol | EDQM, SFDA (Saudi Arabia) | 2 |
| Donepezil | EDQM, SFDA (Saudi Arabia) | 2 |
| Irbesartan | EDQM, SFDA (Saudi Arabia) | 2 |
| Teriflunomide | EDQM, SFDA (Saudi Arabia) | 2 |
| Zolpidem | EDQM, SFDA (Saudi Arabia) | 2 |
| Amlodipine | EDQM | 1 |
| Amlodipine Besilate | EDQM | 1 |
| Aripiprazole | EDQM | 1 |
| Bendroflumethiazide | EDQM | 1 |
| Bumetanide | EDQM | 1 |
| Buprenorphine | EDQM | 1 |
| Buspirone | EDQM | 1 |
| Clonidine | EDQM | 1 |
| Lamotrigine | EDQM | 1 |
| Meloxicam | EDQM | 1 |
| Memantine | SFDA (Saudi Arabia) | 1 |
| Metronidazole | EDQM | 1 |
| Nateglinide | EDQM | 1 |
| Phenylephrine | EDQM | 1 |
| Piroxicam | EDQM | 1 |
| Pramipexole Dihydrochloride | EDQM | 1 |
| Quetiapine | EDQM | 1 |
| Rizatriptan | EDQM | 1 |
| Solifenacin Succinate | EDQM | 1 |
| Tadalafil | EDQM | 1 |
| Tamsulosin | EDQM | 1 |
| Tizanidine | EDQM | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| TMDA (TZ) | 38 | None |
| MCAZ (ZW) | 38 | None |
| ZAMRA (ZM) | 18 | None |
| NAFDAC (NG) | 16 | 1 |
| DAV (Vietnam) | 12 | None |
| BOMRA (BW) | 5 | None |
| EMA | None | 8 |
| MHRA (UK) | None | 5 |
| US FDA | None | 5 |
| ANVISA (Brazil) | None | 5 |
| FDA (GH) | None | 3 |
| Year | Revenue | Exports | Destinations |
|---|---|---|---|
| 2026 YTD | Not reported | $25.5M | 48 |
| 2025 | $242.3M | $188.4M | 68 |
| 2024 | $213.3M | $201.1M | 67 |
| 2023 | $162.6M | $161.7M | 69 |
Export figures are customs aggregates. We do not publish the identity of any buyer. Revenue shown in US dollars, converted from the reported currency.
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