Register entryShortage reported
Apotex Inc.
- Registered sites
- 6
- Drug products
- 370
- Live patents
- 20
- Countries
- 2
- Base
- Canada
Authorisation
Registered operations
What the FDA has registered these sites to do. This is the regulatory record, not a marketing claim.
Analytical testingActive ingredient (API) manufactureFinished drug manufacturePackaging
Sites
Facilities
6| Site | Location | Operations | FEI |
|---|---|---|---|
| Apotex Inc. | BrantfordCanada | Analytical testing, Active ingredient (API) manufacture | 3000114091 |
| Apotex Inc. | EtobicokeCanada | Analytical testing, Finished drug manufacture | 3002808376 |
| Apotex Inc. | Richmond HillCanada | Analytical testing, Finished drug manufacture | 3001617666 |
| Apotex Inc. | TorontoCanada | Analytical testing, Finished drug manufacture, Packaging | 3002906944 |
| Apotex Research Private Limited | BangaloreIndia | Analytical testing | 3007078919 |
| Apotex Research Private Limited | BengaluruIndia | Analytical testing, Finished drug manufacture | 3006076314 |
Alert
Products in shortage
8| Drug | Presentation | Availability |
|---|---|---|
| Desmopressin Acetate Spray | Desmopressin Acetate (needs No Refrigeration), Spray, 10 ug (NDC 60505-0815-0) | Limited Availability |
| Lisdexamfetamine Dimesylate Capsule | Lisdexamfetamine Dimesylate, Capsule, 20 mg (NDC 60505-4740-1) | Limited Availability |
| Lisdexamfetamine Dimesylate Capsule | Lisdexamfetamine Dimesylate, Capsule, 30 mg (NDC 60505-4741-1) | Available |
| Lisdexamfetamine Dimesylate Capsule | Lisdexamfetamine Dimesylate, Capsule, 70 mg (NDC 60505-4745-1) | Available |
| Lisdexamfetamine Dimesylate Capsule | Lisdexamfetamine Dimesylate, Capsule, 50 mg (NDC 60505-4743-1) | Unavailable |
| Lisdexamfetamine Dimesylate Capsule | Lisdexamfetamine Dimesylate, Capsule, 40 mg (NDC 60505-4742-1) | Unavailable |
| Lisdexamfetamine Dimesylate Capsule | Lisdexamfetamine Dimesylate, Capsule, 10 mg (NDC 60505-4739-1) | Available |
| Lisdexamfetamine Dimesylate Capsule | Lisdexamfetamine Dimesylate, Capsule, 60 mg (NDC 60505-4744-1) | Available |
Exclusivity
Patents
20Unexpired Orange Book patents where this company is the application holder.
| Product | Active ingredient | Expiry |
|---|---|---|
| ACETADOTE | ACETYLCYSTEINE | Jul 2031 |
| ACETADOTE | ACETYLCYSTEINE | Apr 2032 |
| CALDOLOR | IBUPROFEN | Sept 2029 |
| CALDOLOR | IBUPROFEN | Sept 2030 |
| CALDOLOR | IBUPROFEN | Mar 2032 |
| EVDI | TRABECTEDIN | Feb 2043 |
| IVRA | MELPHALAN HYDROCHLORIDE | Jun 2036 |
| VIBATIV | TELAVANCIN HYDROCHLORIDE | Jan 2027 |
Catalogue
Marketed products
370Showing 150 of 370.
| Brand | Generic name | Form | Category |
|---|---|---|---|
| ACYCLOVIR | ACYCLOVIR | CAPSULE | ANDA |
| - | ADEFOVIR DIPIVOXIL | POWDER | BULK INGREDIENT |
| - | ALFUZOSIN HYDROCHLORIDE | POWDER | BULK INGREDIENT |
| - | ARIPIPRAZOLE | POWDER | BULK INGREDIENT |
| - | ATOMOXETINE HYDROCHLORIDE | POWDER | BULK INGREDIENT |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | TABLET, FILM COATED | ANDA |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | TABLET, FILM COATED | ANDA |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | TABLET, FILM COATED | ANDA |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | TABLET, FILM COATED | ANDA |
| - | ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE | POWDER | BULK INGREDIENT |
| AZELASTINE HYDROCHLORIDE | AZELASTINE HYDROCHLORIDE | SOLUTION/ DROPS | ANDA |
| Abiraterone Acetate | Abiraterone Acetate | TABLET | ANDA |
| Adefovir dipivoxil | adefovir dipivoxil | TABLET | ANDA |
| Alfuzosin Hydrochloride | Alfuzosin Hydrochloride | TABLET, EXTENDED RELEASE | ANDA |
| Ambrisentan | AMBRISENTAN | TABLET, FILM COATED | ANDA |
| Ambrisentan | AMBRISENTAN | TABLET, FILM COATED | ANDA |
| Amlodipine and Atorvastatin | Amlodipine and Atorvastatin | TABLET, FILM COATED | ANDA |
| Amlodipine and Atorvastatin | Amlodipine and Atorvastatin | TABLET, FILM COATED | ANDA |
| Amlodipine and Atorvastatin | Amlodipine and Atorvastatin | TABLET, FILM COATED | ANDA |
| Amlodipine and Atorvastatin | Amlodipine and Atorvastatin | TABLET, FILM COATED | ANDA |
| Amlodipine and Atorvastatin | Amlodipine and Atorvastatin | TABLET, FILM COATED | ANDA |
| Amlodipine and Atorvastatin | Amlodipine and Atorvastatin | TABLET, FILM COATED | ANDA |
| Amlodipine and Atorvastatin | Amlodipine and Atorvastatin | TABLET, FILM COATED | ANDA |
| Amlodipine and Atorvastatin | Amlodipine and Atorvastatin | TABLET, FILM COATED | ANDA |
| Atomoxetine Hydrochloride | atomoxetine hydrochloride | CAPSULE | ANDA |
| Atomoxetine Hydrochloride | atomoxetine hydrochloride | CAPSULE | ANDA |
| Atomoxetine Hydrochloride | atomoxetine hydrochloride | CAPSULE | ANDA |
| Atomoxetine Hydrochloride | atomoxetine hydrochloride | CAPSULE | ANDA |
| Atomoxetine Hydrochloride | atomoxetine hydrochloride | CAPSULE | ANDA |
| Atomoxetine Hydrochloride | atomoxetine hydrochloride | CAPSULE | ANDA |
| Atomoxetine Hydrochloride | atomoxetine hydrochloride | CAPSULE | ANDA |
| Atropine | Atropine Sulfate | SOLUTION/ DROPS | ANDA |
| Azacitidine | azacitidine | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | ANDA |
| Azelastine Hydrochloride | azelastine hydrochloride | SPRAY, METERED | ANDA |
| Azelastine hydrochloride and Fluticasone propionate | Azelastine hydrochloride and Fluticasone propionate | SPRAY, METERED | ANDA |
| BORTEZOMIB | bortezomib | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | ANDA |
| Balsalazide Disodium | Balsalazide Disodium | CAPSULE | ANDA |
| Bendamustine Hydrochloride | Bendamustine Hydrochloride | INJECTION, SOLUTION | NDA |
| Bimatoprost | Bimatoprost | SOLUTION/ DROPS | ANDA |
| Brimonidine Tartrate | brimonidine tartrate | SOLUTION/ DROPS | ANDA |
| Brimonidine Tartrate | brimonidine tartrate | SOLUTION/ DROPS | ANDA |
| Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution | Brimonidine Tartrate and Timolol Maleate | SOLUTION | ANDA |
| Brivaracetam | Brivaracetam | TABLET | ANDA |
| Brivaracetam | Brivaracetam | TABLET | ANDA |
| Brivaracetam | Brivaracetam | TABLET | ANDA |
| Brivaracetam | Brivaracetam | TABLET | ANDA |
| Brivaracetam | Brivaracetam | TABLET | ANDA |
| Bromfenac Ophthalmic Solution, 0.07% | Bromfenac Sodium | SOLUTION/ DROPS | ANDA |
| Budesonide | Budesonide | SPRAY, METERED | ANDA |
| Bupropion Hydrochloride | Bupropion Hydrochloride | TABLET, FILM COATED | ANDA |
| Bupropion Hydrochloride | Bupropion Hydrochloride | TABLET, FILM COATED | ANDA |
| Butorphanol Tartrate | Butorphanol Tartrate | SPRAY | ANDA |
| CARBAMAZEPINE | CARBAMAZEPINE | TABLET | ANDA |
| CARBOPLATIN | CARBOPLATIN | INJECTION, SOLUTION | ANDA |
| CISplatin | CISplatin | INJECTION, SOLUTION | ANDA |
| Calcitonin Salmon | Calcitonin Salmon | SPRAY, METERED | ANDA |
| Carbamazepine | Carbamazepine | CAPSULE, EXTENDED RELEASE | ANDA |
| Carbamazepine | Carbamazepine | CAPSULE, EXTENDED RELEASE | ANDA |
| Carbamazepine | Carbamazepine | CAPSULE, EXTENDED RELEASE | ANDA |
| Cefazolin | Cefazolin | INJECTION, POWDER, FOR SOLUTION | ANDA |
| Cefazolin | Cefazolin | INJECTION, POWDER, FOR SOLUTION | ANDA |
| Cefazolin | Cefazolin | INJECTION, POWDER, FOR SOLUTION | ANDA |
| Cefazolin | Cefazolin | INJECTION, POWDER, FOR SOLUTION | ANDA |
| Cefazolin | Cefazolin | INJECTION, POWDER, FOR SOLUTION | ANDA |
| Cefazolin | Cefazolin | INJECTION, POWDER, FOR SOLUTION | ANDA |
| Cefepime | Cefepime | INJECTION, POWDER, FOR SOLUTION | ANDA |
| Cefepime | Cefepime | INJECTION, POWDER, FOR SOLUTION | ANDA |
| Cefepime | Cefepime | INJECTION, POWDER, FOR SOLUTION | ANDA |
| Cefepime | Cefepime | INJECTION, POWDER, FOR SOLUTION | ANDA |
| Cefepime | Cefepime | INJECTION, POWDER, FOR SOLUTION | ANDA |
| Cefepime | Cefepime | INJECTION, POWDER, FOR SOLUTION | ANDA |
| Ceftaroline Fosamil | Ceftaroline Fosamil | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | ANDA |
| Ceftaroline Fosamil | Ceftaroline Fosamil | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | ANDA |
| Ceftriaxone Sodium | Ceftriaxone Sodium | INJECTION, POWDER, FOR SOLUTION | ANDA |
| Ceftriaxone Sodium | Ceftriaxone Sodium | INJECTION, POWDER, FOR SOLUTION | ANDA |
| Ceftriaxone Sodium | Ceftriaxone Sodium | INJECTION, POWDER, FOR SOLUTION | ANDA |
| Ceftriaxone Sodium | Ceftriaxone Sodium | INJECTION, POWDER, FOR SOLUTION | ANDA |
| Ceftriaxone Sodium | Ceftriaxone Sodium | INJECTION, POWDER, FOR SOLUTION | ANDA |
| Celecoxib | Celecoxib | CAPSULE | ANDA |
| Celecoxib | Celecoxib | CAPSULE | ANDA |
| Cetrorelix acetate | Cetrorelix Acetate for Injection | KIT | ANDA |
| Cladribine | Cladribine | TABLET | ANDA |
| Clopidogrel | clopidogrel bisulfate | TABLET, FILM COATED | ANDA |
| Clopidogrel | clopidogrel bisulfate | TABLET, FILM COATED | ANDA |
| Clorazepate Dipotassium | Clorazepate Dipotassium | TABLET | ANDA |
| Clorazepate Dipotassium | Clorazepate Dipotassium | TABLET | ANDA |
| Clorazepate Dipotassium | Clorazepate Dipotassium | TABLET | ANDA |
| CycloSPORINE, Modfied | Cyclosporine | CAPSULE, LIQUID FILLED | ANDA |
| CycloSPORINE, Modfied | Cyclosporine | CAPSULE, LIQUID FILLED | ANDA |
| CycloSPORINE, Modfied | Cyclosporine | CAPSULE, LIQUID FILLED | ANDA |
| Cyclosporine | Cyclosporine | CAPSULE, GELATIN COATED | ANDA |
| Cyclosporine | Cyclosporine | CAPSULE, GELATIN COATED | ANDA |
| Cyclosporine | Cyclosporine | EMULSION | NDA AUTHORIZED GENERIC |
| - | DABIGATRAN ETEXILATE MESYLATE | POWDER | BULK INGREDIENT |
| - | DEFERPRONE | POWDER | BULK INGREDIENT |
| DESMOPRESSIN ACETATE | DESMOPRESSIN ACETATE | SPRAY | ANDA |
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE | ANDA |
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE | ANDA |
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE | ANDA |
| DROSPIRENONE AND ETHINYL ESTRADIOL | DROSPIRENONE AND ETHINYL ESTRADIOL | KIT | ANDA |
| Dapagliflozin | DAPAGLIFLOZIN | TABLET, FILM COATED | ANDA |
| Dapagliflozin | DAPAGLIFLOZIN | TABLET, FILM COATED | ANDA |
| Daptomycin | Daptomycin | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | ANDA |
| Dasatinib | Dasatinib | TABLET, FILM COATED | ANDA |
| Dasatinib | Dasatinib | TABLET, FILM COATED | ANDA |
| Dasatinib | Dasatinib | TABLET, FILM COATED | ANDA |
| Dasatinib | Dasatinib | TABLET, FILM COATED | ANDA |
| Dasatinib | Dasatinib | TABLET, FILM COATED | ANDA |
| Dasatinib | Dasatinib | TABLET, FILM COATED | ANDA |
| Deferoxamine mesylate | Deferoxamine mesylate | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | ANDA |
| Deferoxamine mesylate | Deferoxamine mesylate | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | ANDA |
| Desmopressin Acetate | desmopressin acetate | TABLET | ANDA |
| Desmopressin Acetate | desmopressin acetate | TABLET | ANDA |
| Dexamethasone | Dexamethasone | TABLET | ANDA |
| Dexamethasone | Dexamethasone | TABLET | ANDA |
| Dexamethasone | Dexamethasone | TABLET | ANDA |
| Dexamethasone | Dexamethasone | TABLET | ANDA |
| Dexamethasone | Dexamethasone | TABLET | ANDA |
| Dexamethasone | Dexamethasone | TABLET | ANDA |
| Dexamethasone | Dexamethasone | TABLET | ANDA |
| Diclofenac Sodium | Diclofenac Sodium | SOLUTION | ANDA |
| Doxazosin | Doxazosin | TABLET | ANDA |
| Doxazosin | Doxazosin | TABLET | ANDA |
| Doxazosin | Doxazosin | TABLET | ANDA |
| Doxazosin | Doxazosin | TABLET | ANDA |
| Doxycycline | Doxycycline | CAPSULE | ANDA |
| EVDI | Trabectedin | INJECTION, SOLUTION, CONCENTRATE | NDA |
| Ertapenem | Ertapenem Sodium | INJECTION | ANDA |
| Eslicarbazepine Acetate | Eslicarbazepine Acetate | TABLET | ANDA |
| Eslicarbazepine Acetate | Eslicarbazepine Acetate | TABLET | ANDA |
| Eslicarbazepine Acetate | Eslicarbazepine Acetate | TABLET | ANDA |
| Eslicarbazepine Acetate | Eslicarbazepine Acetate | TABLET | ANDA |
| Etodolac | Etodolac | CAPSULE | ANDA |
| Etodolac | Etodolac | CAPSULE | ANDA |
| Etodolac | Etodolac | TABLET, FILM COATED | ANDA |
| Etodolac | Etodolac | TABLET, FILM COATED | ANDA |
| - | FLUTICASONE PROPIONATE | POWDER | BULK INGREDIENT |
| Fenofibrate | Fenofibrate | CAPSULE | ANDA |
| Fenofibrate | Fenofibrate | CAPSULE | ANDA |
| Fidaxomicin | Fidaxomicin | TABLET, FILM COATED | ANDA |
| Fingolimod | Fingolimod | CAPSULE | ANDA |
| Fluticasone Propionate | Fluticasone Propionate | SPRAY, METERED | ANDA |
| Fluticasone Propionate | Fluticasone Propionate | SPRAY, METERED | ANDA |
| Fluticasone Propionate | Fluticasone Propionate | SPRAY, METERED | ANDA |
| - | Fluticasone Propionate | SPRAY, METERED | DRUG FOR FURTHER PROCESSING |
| Fluvoxamine Maleate | Fluvoxamine Maleate | TABLET | ANDA |
| Fluvoxamine Maleate | Fluvoxamine Maleate | TABLET | ANDA |
| Fluvoxamine Maleate | Fluvoxamine Maleate | TABLET | ANDA |
| Glipizide | Glipizide | TABLET | ANDA |
| Glipizide | Glipizide | TABLET | ANDA |
Provenance
Facility and operations data from the FDA Drug Establishments Current Registration Site. Product data from the openFDA National Drug Code Directory. Patent and exclusivity data from the FDA Orange Book. Shortage data from the FDA drug shortage database. Contact details the FDA publishes for registered establishments are deliberately not reproduced here. This entry is compiled from public records and has not been claimed by the company.