Gland Pharma is an API and finished-dose manufacturer based in India. It holds 75 active US drug master files and 3 valid CEPs. Its filings concentrate with US FDA, ARCSA (EC) and MINSA (CR). Its GMP standing is certified by ANVISA (Brazil), EMA and US FDA, among 7 authorities. Its most recent recorded inspection, by US FDA, closed on 25 July 2024 as VAI. Customs aggregates show $341.9M of exports covering 3,241 molecules to 71 destinations in 2025.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Hyderabad, United Arab Emirates | Not on file |
| Hyderabad, United Arab Emirates | Not on file |
| HYDERABAD, India | Not on file |
| MEDAK DISTRICT, India | Not on file |
| Hyderabad, India | 3009864167 |
| Hyderabad, India | 3002647489 |
10 further sites are on record.
| Molecule | Regulators | Docs |
|---|---|---|
| Tigecycline | SFDA (Saudi Arabia), US FDA | 8 |
| Atracurium Besylate | EDQM, US FDA | 6 |
| Rocuronium | EDQM, SFDA (Saudi Arabia), US FDA | 6 |
| Cisatracurium | SFDA (Saudi Arabia), US FDA | 5 |
| Dexmedetomidine | SFDA (Saudi Arabia), US FDA | 5 |
| (21R)-Argatroban | US FDA | 4 |
| Aripiprazole | US FDA | 4 |
| Dexrazoxane | US FDA | 4 |
| Epinephrine | US FDA | 4 |
| Indomethacin | US FDA | 4 |
| Regadenoson | US FDA | 4 |
| Tirofiban | SFDA (Saudi Arabia), US FDA | 4 |
| Ertapenem | US FDA | 3 |
| Fomepizole | SFDA (Saudi Arabia), US FDA | 3 |
| Foscarnet | SFDA (Saudi Arabia), US FDA | 3 |
| Acetazolamide | US FDA | 2 |
| Betamethasone | US FDA | 2 |
| Bortezomib | SFDA (Saudi Arabia), US FDA | 2 |
| Caspofungin | US FDA | 2 |
| Chlorothiazide | US FDA | 2 |
| Cupric Sulfate | US FDA | 2 |
| Cysteamine | US FDA | 2 |
| Dalteparin | US FDA | 2 |
| Dantrolene | US FDA | 2 |
| Diphenhydramine | US FDA | 2 |
| Doxycycline | US FDA | 2 |
| Edaravone | US FDA | 2 |
| Enoxaparin | EDQM | 2 |
| Erythromycin | US FDA | 2 |
| Etomidate | US FDA | 2 |
| Fluphenazine | US FDA | 2 |
| Fosaprepitant | US FDA | 2 |
| Fosphenytoin | US FDA | 2 |
| Fulvestrant | US FDA | 2 |
| Glatiramer | US FDA | 2 |
| Heparin Sodium | US FDA | 2 |
| Iron Dextran | US FDA | 2 |
| Iron Sucrose | US FDA | 2 |
| Isavuconazonium | US FDA | 2 |
| Isoprenaline | US FDA | 2 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| US FDA | 250 | 8 |
| ARCSA (EC) | 19 | None |
| MINSA (CR) | 16 | None |
| INVIMA (CO) | 15 | None |
| NPRA (MY) | 13 | None |
| DIGEMAPS (DO) | 9 | None |
| ANVISA (Brazil) | None | 36 |
| EMA | None | 20 |
| MHRA (UK) | None | 4 |
| CDSCO (India) | None | 4 |
| NAFDAC (NG) | None | 3 |
| GOSPHARMNADZOR (BY) | None | 1 |
| Year | Revenue | Exports | Destinations |
|---|---|---|---|
| 2025 | $656.1M | $341.9M | 71 |
| 2024 | $679.3M | $370.5M | 70 |
| 2023 | $441.0M | $359.4M | 70 |
| 2022 | Not reported | $348.6M | 81 |
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. Gland Pharma comes back tiered against every other supplier able to file there.
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