Apitoria Pharma is an API manufacturer based in India. It holds 303 active US drug master files and 173 valid CEPs. Its GMP standing is certified by US FDA, EMA and MFDS (Korea). Its most recent recorded inspection, by US FDA, closed on 12 December 2025 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Hyderabad, India | Not on file |
| Anakapalli, India | 3007698192 |
| Sangareddy, India | 3004051616 |
| Sangareddy, India | 3004021253 |
| Srikakulam, India | 3004611182 |
| Sangareddy, India | 3004086884 |
2 further sites are on record.
| Molecule | Regulators | Docs |
|---|---|---|
| Ampicillin | EDQM, SFDA (Saudi Arabia), US FDA | 6 |
| Nevirapine | EDQM, US FDA | 6 |
| Mirtazapine | EDQM, SFDA (Saudi Arabia), US FDA | 5 |
| Omeprazole | EDQM, US FDA | 5 |
| Amoxicillin | EDQM, US FDA | 4 |
| Clopidogrel | EDQM, US FDA | 4 |
| Esomeprazole | EDQM, US FDA | 4 |
| Finasteride | EDQM, SFDA (Saudi Arabia), US FDA | 4 |
| Fluconazole | EDQM, US FDA | 4 |
| Lacosamide | EDQM, US FDA | 4 |
| Lamivudine | EDQM, US FDA | 4 |
| Olanzapine | EDQM, US FDA | 4 |
| Olmesartan Medoxomil | EDQM | 4 |
| Oxacillin | EDQM, US FDA | 4 |
| Pantoprazole | EDQM, US FDA | 4 |
| Sulbactam | EDQM, US FDA | 4 |
| Abacavir | EDQM, US FDA | 3 |
| Amlodipine | EDQM, SFDA (Saudi Arabia), US FDA | 3 |
| Aripiprazole | EDQM, US FDA | 3 |
| Carvedilol | EDQM, US FDA | 3 |
| Cefixime | EDQM, US FDA | 3 |
| Cephalexin | EDQM, US FDA | 3 |
| Citalopram | EDQM, US FDA | 3 |
| Duloxetine | EDQM, US FDA | 3 |
| Escitalopram | EDQM, US FDA | 3 |
| Flucloxacillin | EDQM | 3 |
| Fluoxetine | EDQM, US FDA | 3 |
| Gabapentin | EDQM, US FDA | 3 |
| Hydrochlorothiazide | EDQM, US FDA | 3 |
| Levetiracetam | EDQM, US FDA | 3 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| US FDA | None | 5 |
| EMA | None | 3 |
| MFDS (Korea) | None | 2 |
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.
Ask Fred what the record holds on Apitoria Pharma, including filings and inspection history.
Chat with Fred, your AI analystRanked by shared active ingredients where we have them, otherwise by country and comparable credentials.