Apotex is an API and finished-dose manufacturer based in Canada. It holds 69 active US drug master files and 9 valid CEPs. Its filings concentrate with Health Canada, US FDA and MEDSAFE (NZ). Its GMP standing is certified by US FDA, CDSCO (India) and ANVISA (Brazil). Its most recent recorded inspection, by US FDA, closed on 31 July 2025 as NAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| ONTARIO, United Arab Emirates | Not on file |
| Ontario, United Arab Emirates | Not on file |
| TORONTO, United Arab Emirates | Not on file |
| Ontario, United Arab Emirates | Not on file |
| Toronto, United Arab Emirates | Not on file |
| Bangalore, United Arab Emirates | Not on file |
6 further sites are on record.
| Molecule | Regulators | Docs |
|---|---|---|
| Perindopril | SFDA (Saudi Arabia), US FDA | 5 |
| Olanzapine | SFDA (Saudi Arabia), US FDA | 4 |
| Cabergoline | EDQM, SFDA (Saudi Arabia) | 3 |
| Mycophenolate Mofetil | EDQM, SFDA (Saudi Arabia) | 3 |
| Varenicline | SFDA (Saudi Arabia), US FDA | 3 |
| Alfuzosin | SFDA (Saudi Arabia), US FDA | 2 |
| Dabigatran Etexilate | SFDA (Saudi Arabia), US FDA | 2 |
| Levofloxacin | SFDA (Saudi Arabia), US FDA | 2 |
| Perindopril Tert-Butylamine | EDQM | 2 |
| Pravastatin | EDQM, US FDA | 2 |
| Rivastigmine | US FDA | 2 |
| Warfarin | SFDA (Saudi Arabia), US FDA | 2 |
| Ziprasidone | US FDA | 2 |
| Abacavir | US FDA | 1 |
| Adefovir Dipivoxil | US FDA | 1 |
| Alendronic Acid | US FDA | 1 |
| Anastrozole | US FDA | 1 |
| Aripiprazole | US FDA | 1 |
| Atomoxetine | US FDA | 1 |
| Atorvastatin | US FDA | 1 |
| Atorvastatin Calcium Propylene Glycol Solvate | SFDA (Saudi Arabia) | 1 |
| Axitinib | US FDA | 1 |
| Brexpiprazole | US FDA | 1 |
| Budesonide | US FDA | 1 |
| Cevimeline | US FDA | 1 |
| Clonazepam | US FDA | 1 |
| Cyclosporine | US FDA | 1 |
| Darifenacin | US FDA | 1 |
| Dasatinib | SFDA (Saudi Arabia) | 1 |
| Deferasirox | SFDA (Saudi Arabia) | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| Health Canada | 2,370 | None |
| US FDA | 649 | 3 |
| MEDSAFE (NZ) | 350 | None |
| SFDA (Saudi Arabia) | 60 | None |
| MINSA (CR) | 37 | None |
| TITCK (TR) | 33 | None |
| CDSCO (India) | None | 2 |
| ANVISA (Brazil) | 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. Apotex comes back tiered against every other supplier able to file there.
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