Hetero is an API and finished-dose manufacturer based in India. It holds 380 active US drug master files and 67 valid CEPs. Its filings concentrate with SAHPRA (ZA), DAV (Vietnam) and ARCSA (EC). Its GMP standing is certified by EMA, US FDA and ANVISA (Brazil), among 12 authorities. Its most recent recorded inspection, by US FDA, closed on 16 May 2025 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Telangana, Colombia | Not on file |
| Hyderabad, Colombia | Not on file |
| Solan, Colombia | Not on file |
| Baddi, Colombia | Not on file |
| VISAKHAPATNAM, India | Not on file |
| ANDHRA PRADESH, India | Not on file |
6 further sites are on record.
| Molecule | Regulators | Docs |
|---|---|---|
| Esomeprazole | US FDA | 7 |
| Lamivudine | EDQM, SFDA (Saudi Arabia), US FDA | 7 |
| Lisinopril | SFDA (Saudi Arabia), US FDA | 7 |
| Omeprazole | SFDA (Saudi Arabia), US FDA | 7 |
| Escitalopram | EDQM, SFDA (Saudi Arabia), US FDA | 6 |
| Moxifloxacin | SFDA (Saudi Arabia), US FDA | 6 |
| Ritonavir | SFDA (Saudi Arabia), US FDA | 6 |
| Sertraline | SFDA (Saudi Arabia), US FDA | 6 |
| Aripiprazole | EDQM, SFDA (Saudi Arabia), US FDA | 5 |
| Atovaquone | SFDA (Saudi Arabia), US FDA | 5 |
| Donepezil | SFDA (Saudi Arabia), US FDA | 5 |
| Efavirenz | SFDA (Saudi Arabia), US FDA | 5 |
| Gabapentin | SFDA (Saudi Arabia), US FDA | 5 |
| Imatinib Mesilate | EDQM | 5 |
| Lacosamide | SFDA (Saudi Arabia), US FDA | 5 |
| Levetiracetam | EDQM, SFDA (Saudi Arabia), US FDA | 5 |
| Lopinavir | SFDA (Saudi Arabia), US FDA | 5 |
| Nebivolol | SFDA (Saudi Arabia), US FDA | 5 |
| Sildenafil | SFDA (Saudi Arabia), US FDA | 5 |
| Tenofovir Disoproxil | SFDA (Saudi Arabia), US FDA | 5 |
| Atomoxetine | EDQM, SFDA (Saudi Arabia), US FDA | 4 |
| Bupropion | US FDA | 4 |
| Citalopram | US FDA | 4 |
| Darunavir | US FDA | 4 |
| Dexlansoprazole | US FDA | 4 |
| Dolutegravir | SFDA (Saudi Arabia), US FDA | 4 |
| Emtricitabine | SFDA (Saudi Arabia), US FDA | 4 |
| Fenofibrate | SFDA (Saudi Arabia), US FDA | 4 |
| Finasteride | EDQM, SFDA (Saudi Arabia), US FDA | 4 |
| Letrozole | EDQM, SFDA (Saudi Arabia), US FDA | 4 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| SAHPRA (ZA) | 407 | None |
| DAV (Vietnam) | 208 | None |
| ARCSA (EC) | 167 | None |
| INVIMA (CO) | 152 | 3 |
| MINSA (CR) | 148 | None |
| TMDA (TZ) | 135 | None |
| EMA | None | 28 |
| US FDA | None | 9 |
| ANVISA (Brazil) | None | 8 |
| MFDS (Korea) | None | 6 |
| EAEU_EEC | None | 5 |
| NCELS (KZ) | None | 4 |
| NAFDAC (NG) | None | 3 |
| CDSCO (India) | None | 3 |
| GOSPHARMNADZOR (BY) | None | 1 |
| UZPHARM (UZ) | None | 1 |
| FDA (GH) | None | 1 |
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. Hetero comes back tiered against every other supplier able to file there.
Start for freeRanked by shared active ingredients where we have them, otherwise by country and comparable credentials.