Drug factory · FDA FEI 3002808376
Apotex Inc.
50 Steinway Blvd., Etobicoke, Canada
No problems found at FDA's last inspection, Sep 27, 2024.
No Action Indicated: inspectors found no objectionable conditions.
9 drug inspections on record since 2008: 6 with no problems, 2 with problems fixed voluntarily, 1 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Bupropion | Makes it and tests it | BluePoint Laboratories. | 68001-308, 68001-309 |
| Dabigatran | Makes it and tests it | Apotex Corp. | 60505-4347, 60505-4348, 60505-4349 |
| Desmopressin | Makes it | BluePoint Laboratories. | 68001-574, 68001-575 |
| Diltiazem | Makes it and tests it | Northstar Rx LLC. | 16714-523, 16714-524, 16714-525 |
| Etodolac | Makes it and tests it | Medsource Pharmaceuticals | 45865-206 |
| Hydrochlorothiazide and Triamterene | Makes it and tests it | BluePoint Laboratories. | 68001-327, 68001-328 |
| Ibandronic Acid | Makes it | Golden State Medical Supply, Inc. | 60429-643 |
| Omeprazole | Makes it | New Horizon Rx Group, LLC | 58517-020 |
| Selegiline | Makes it and tests it | Apotex Corp. | 60505-3438 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Sep 27, 2024 | No problems found | Bioresearch Monitoring | — |
| Feb 23, 2024 | No problems found | Drug Quality Assurance | — |
| Nov 8, 2019 | No problems found | Drug Quality Assurance | — |
| Jul 12, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 8, 2017 | No problems found | Drug Quality Assurance | — |
| May 27, 2016 | No problems found | Drug Quality Assurance | — |
| Sep 13, 2013 | No problems found | Drug Quality Assurance | — |
| Feb 11, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 19, 2008 | Serious problems, FDA action | Drug Quality Assurance | — |
Registered with FDA for: analysis; manufacture.