Register entryShortage reported
- Registered sites
- 6
- Active NDC listings
- 372
- Labeller names
- 4
- Live patents
- 20
- Exclusivities
- 1
- Shortage listings
- 10
- Countries
- 2
- Base
- Canada
Authorisation
Registered operations
Analytical testing6Active ingredient (API) manufacture1Finished drug manufacture4Packaging1
Sites
Registered establishments
6| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Apotex Inc. | 50 Spalding Drive, Brantford, Ontario N3T 6B8, Canada (CAN) | Analytical testing, Active ingredient (API) manufacture | 3000114091248501905 |
| Apotex Inc. | 50 Steinway Blvd., Etobicoke, Ontario M9W 6Y3, Canada (CAN) | Analytical testing, Finished drug manufacture | 3002808376205576023 |
| Apotex Inc. | 380 Elgin Mills Road East, Richmond Hill, Ontario L4C 5H2, Canada (CAN) | Analytical testing, Finished drug manufacture | 3001617666255092496 |
| Apotex Inc. | 285 Garyray Drive, Toronto, Ontario M9L 1P2, Canada (CAN) | Analytical testing, Finished drug manufacture, Packaging | 3002906944203201673 |
| Apotex Research Private LimitedRegistrant: Apotex Inc. | Bioequivalence Center, Site No. 2, Bommasandra Industrial Area, Phase IV, Jigani Link Road, Bangalore, Karnataka 560099, India (IND) | Analytical testing | 3007078919650081412 |
| Apotex Research Private LimitedRegistrant: Apotex Inc. | Plot No.1 And 2, Bommasandra Industrial Area, 4th Phase, Jigani Link Road, Bengaluru, Karnataka 560099, India (IND) | Analytical testing, Finished drug manufacture | 3006076314862584104 |
Alert
Drug shortage listings
10| Drug | Presentation | Status | Availability | Posted / updated |
|---|---|---|---|---|
| Desmopressin Acetate SprayHematology | Desmopressin Acetate (needs No Refrigeration), Spray, 10 ug (NDC 60505-0815-0) | Current | Available | 12 Mar 202116 Sept 2026 |
| Lisdexamfetamine Dimesylate CapsulePsychiatry | Lisdexamfetamine Dimesylate, Capsule, 20 mg (NDC 60505-4740-1) | Current | Unavailable | 1 Nov 202316 Sept 2026 |
| Lisdexamfetamine Dimesylate CapsulePsychiatry | Lisdexamfetamine Dimesylate, Capsule, 30 mg (NDC 60505-4741-1) | Current | Available | 1 Nov 202316 Sept 2026 |
| Lisdexamfetamine Dimesylate CapsulePsychiatry | Lisdexamfetamine Dimesylate, Capsule, 70 mg (NDC 60505-4745-1) | Current | Available | 1 Nov 202316 Sept 2026 |
| Lisdexamfetamine Dimesylate CapsulePsychiatry | Lisdexamfetamine Dimesylate, Capsule, 60 mg (NDC 60505-4744-1) | Current | Available | 1 Nov 202316 Sept 2026 |
| Lisdexamfetamine Dimesylate CapsulePsychiatry | Lisdexamfetamine Dimesylate, Capsule, 50 mg (NDC 60505-4743-1) | Current | Available | 1 Nov 202316 Sept 2026 |
| Lisdexamfetamine Dimesylate CapsulePsychiatry | Lisdexamfetamine Dimesylate, Capsule, 40 mg (NDC 60505-4742-1) | Current | Available | 1 Nov 202316 Sept 2026 |
| Lisdexamfetamine Dimesylate CapsulePsychiatry | Lisdexamfetamine Dimesylate, Capsule, 10 mg (NDC 60505-4739-1) | Current | Available | 1 Nov 202316 Sept 2026 |
| Icosapent Ethyl CapsuleCardiovascular | Icosapent Ethyl, Capsule, 1 g (NDC 61474-9711-1) | To Be Discontinued | - | 1 Apr 20261 Apr 2026 |
| Icosapent Ethyl CapsuleCardiovascular | Icosapent Ethyl, Capsule, 1 g (NDC 60429-005-12) | To Be Discontinued | - | 1 Apr 20261 Apr 2026 |
Catalogue
Drug listings by form and route
372372 active NDC listings: 341 human prescription drug, 21 bulk ingredient, 8 human otc drug, 2 drug for further processing. By marketing category: ANDA 330, BULK INGREDIENT 21, NDA 14, NDA AUTHORIZED GENERIC 4, DRUG FOR FURTHER PROCESSING 3.
| Dosage form | NDCs |
|---|---|
| tablet | 84 |
| tablet, film coated | 75 |
| capsule | 49 |
| injection, powder, for solution | 21 |
| powder | 21 |
| spray, metered | 13 |
| injection, solution | 12 |
| injection, powder, lyophilized, for solution | 11 |
| kit | 11 |
| injection | 10 |
| solution/ drops | 10 |
| tablet, film coated, extended release | 10 |
| tablet, extended release | 9 |
| solution | 8 |
| capsule, extended release | 6 |
| Route | NDCs |
|---|---|
| oral | 253 |
| intravenous | 56 |
| intramuscular | 16 |
| nasal | 14 |
| ophthalmic | 13 |
| subcutaneous | 5 |
| auricular (otic) | 1 |
| intraocular | 1 |
| topical | 1 |
| Labeller name on the listing | NDCs |
|---|---|
| apotex corp. | 301 |
| apotex corp | 49 |
| apotex inc. | 21 |
| apotex corp. | 1 |
Exclusivity
Patents and exclusivities
20| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 7531623 | VIBATIVtelavancin hydrochloride | substance | Jan 2027 |
| 8735452 | CALDOLORibuprofen | use | Sept 2029 |
| 8871810 | CALDOLORibuprofen | use | Sept 2029 |
| 9114068 | CALDOLORibuprofen | use | Sept 2029 |
| 9138404 | CALDOLORibuprofen | use | Sept 2029 |
| 9295639 | CALDOLORibuprofen | use | Sept 2029 |
| 9649284 | CALDOLORibuprofen | use | Sept 2029 |
| 9012508 | CALDOLORibuprofen | use | Sept 2030 |
| 9327028 | ACETADOTEacetylcysteine | use | Jul 2031 |
| 11806400 | CALDOLORibuprofen | use | Mar 2032 |
| 9072661 | CALDOLORibuprofen | use | Mar 2032 |
| 9072710 | CALDOLORibuprofen | use | Mar 2032 |
| 8722738 | ACETADOTEacetylcysteine | use | Apr 2032 |
| 10537520 | IVRAmelphalan hydrochloride | product | Jun 2036 |
| 12303506 | EVDItrabectedin | product | Feb 2043 |
| Product | Exclusivity | Until |
|---|---|---|
| ACETADOTEACETYLCYSTEINE | D-196 New dosing schedule | Nov 2027 |
Catalogue
Marketed products
372Showing 150 of 372.
| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| ACYCLOVIR | ACYCLOVIR | capsule, oral | 60505-0042ANDA |
| - | ADEFOVIR DIPIVOXIL | powder | 49867-0074BULK INGREDIENT |
| - | ALFUZOSIN HYDROCHLORIDE | powder | 49867-0049BULK INGREDIENT |
| - | ARIPIPRAZOLE | powder | 49867-0047BULK INGREDIENT |
| - | ATOMOXETINE HYDROCHLORIDE | powder | 49867-0065BULK INGREDIENT |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | tablet, film coated, oral | 60505-2578ANDA |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | tablet, film coated, oral | 60505-2579ANDA |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | tablet, film coated, oral | 60505-2580ANDA |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | tablet, film coated, oral | 60505-2671ANDA |
| - | ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE | powder | 49867-0054BULK INGREDIENT |
| AZELASTINE HYDROCHLORIDE | AZELASTINE HYDROCHLORIDE | solution/ drops, intraocular | 60505-0578ANDA |
| Abiraterone Acetate | Abiraterone Acetate | tablet, oral | 60505-4327ANDA |
| Adefovir dipivoxil | adefovir dipivoxil | tablet, oral | 60505-3947ANDA |
| Alfuzosin Hydrochloride | Alfuzosin Hydrochloride | tablet, extended release, oral | 60505-2850ANDA |
| Ambrisentan | AMBRISENTAN | tablet, film coated, oral | 60505-4552ANDA |
| Ambrisentan | AMBRISENTAN | tablet, film coated, oral | 60505-4553ANDA |
| Amlodipine and Atorvastatin | Amlodipine and Atorvastatin | tablet, film coated, oral | 60505-3478ANDA |
| Amlodipine and Atorvastatin | Amlodipine and Atorvastatin | tablet, film coated, oral | 60505-3479ANDA |
| Amlodipine and Atorvastatin | Amlodipine and Atorvastatin | tablet, film coated, oral | 60505-3483ANDA |
| Amlodipine and Atorvastatin | Amlodipine and Atorvastatin | tablet, film coated, oral | 60505-3484ANDA |
| Amlodipine and Atorvastatin | Amlodipine and Atorvastatin | tablet, film coated, oral | 60505-3488ANDA |
| Amlodipine and Atorvastatin | Amlodipine and Atorvastatin | tablet, film coated, oral | 60505-3489ANDA |
| Amlodipine and Atorvastatin | Amlodipine and Atorvastatin | tablet, film coated, oral | 60505-3492ANDA |
| Amlodipine and Atorvastatin | Amlodipine and Atorvastatin | tablet, film coated, oral | 60505-3493ANDA |
| Atomoxetine Hydrochloride | atomoxetine hydrochloride | capsule, oral | 60505-2830ANDA |
| Atomoxetine Hydrochloride | atomoxetine hydrochloride | capsule, oral | 60505-2831ANDA |
| Atomoxetine Hydrochloride | atomoxetine hydrochloride | capsule, oral | 60505-2832ANDA |
| Atomoxetine Hydrochloride | atomoxetine hydrochloride | capsule, oral | 60505-2833ANDA |
| Atomoxetine Hydrochloride | atomoxetine hydrochloride | capsule, oral | 60505-2834ANDA |
| Atomoxetine Hydrochloride | atomoxetine hydrochloride | capsule, oral | 60505-2835ANDA |
| Atomoxetine Hydrochloride | atomoxetine hydrochloride | capsule, oral | 60505-2836ANDA |
| Atropine | Atropine Sulfate | solution/ drops, ophthalmic | 60505-6226ANDA |
| Azacitidine | azacitidine | injection, powder, lyophilized, for solution, intravenous, subcutaneous | 60505-6271ANDA |
| Azelastine Hydrochloride | azelastine hydrochloride | spray, metered, nasal | 60505-0833ANDA |
| Azelastine hydrochloride and Fluticasone propionate | Azelastine hydrochloride and Fluticasone propionate | spray, metered, nasal | 60505-0953ANDA |
| BORTEZOMIB | bortezomib | injection, powder, lyophilized, for solution, intravenous, subcutaneous | 60505-6050ANDA |
| Balsalazide Disodium | Balsalazide Disodium | capsule, oral | 60505-2575ANDA |
| Bendamustine Hydrochloride | Bendamustine Hydrochloride | injection, solution, intravenous | 60505-6228NDA |
| Bimatoprost | Bimatoprost | solution/ drops, ophthalmic | 60505-0583ANDA |
| Brimonidine Tartrate | brimonidine tartrate | solution/ drops, ophthalmic | 60505-0564ANDA |
| Brimonidine Tartrate | brimonidine tartrate | solution/ drops, ophthalmic | 60505-0577ANDA |
| Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution | Brimonidine Tartrate and Timolol Maleate | solution, ophthalmic | 60505-0589ANDA |
| Brivaracetam | Brivaracetam | tablet, oral | 60505-4723ANDA |
| Brivaracetam | Brivaracetam | tablet, oral | 60505-4724ANDA |
| Brivaracetam | Brivaracetam | tablet, oral | 60505-4725ANDA |
| Brivaracetam | Brivaracetam | tablet, oral | 60505-4726ANDA |
| Brivaracetam | Brivaracetam | tablet, oral | 60505-4727ANDA |
| Bromfenac Ophthalmic Solution, 0.07% | Bromfenac Sodium | solution/ drops, ophthalmic | 60505-1006ANDA |
| Budesonide | Budesonide | spray, metered, nasal | 60505-6129ANDA |
| Bupropion Hydrochloride | Bupropion Hydrochloride | tablet, film coated, oral | 60505-0157ANDA |
| Bupropion Hydrochloride | Bupropion Hydrochloride | tablet, film coated, oral | 60505-0158ANDA |
| Butorphanol Tartrate | Butorphanol Tartrate | spray, nasal | 60505-0813ANDA |
| CARBAMAZEPINE | CARBAMAZEPINE | tablet, oral | 60505-0183ANDA |
| CARBOPLATIN | CARBOPLATIN | injection, solution, intravenous | 60505-6282ANDA |
| CISplatin | CISplatin | injection, solution, intravenous | 60505-6279ANDA |
| Calcitonin Salmon | Calcitonin Salmon | spray, metered, nasal | 60505-0823ANDA |
| Carbamazepine | Carbamazepine | capsule, extended release, oral | 60505-2805ANDA |
| Carbamazepine | Carbamazepine | capsule, extended release, oral | 60505-2806ANDA |
| Carbamazepine | Carbamazepine | capsule, extended release, oral | 60505-2807ANDA |
| Cefazolin | Cefazolin | injection, powder, for solution, intramuscular, intravenous | 60505-6142ANDA |
| Cefazolin | Cefazolin | injection, powder, for solution, intravenous | 60505-6143ANDA |
| Cefazolin | Cefazolin | injection, powder, for solution, intramuscular, intravenous | 60505-6231ANDA |
| Cefazolin | Cefazolin | injection, powder, for solution, intramuscular, intravenous | 60505-6243ANDA |
| Cefazolin | Cefazolin | injection, powder, for solution, intravenous | 60505-6244ANDA |
| Cefazolin | Cefazolin | injection, powder, for solution, intramuscular, intravenous | 60505-6266ANDA |
| Cefepime | Cefepime | injection, powder, for solution, intramuscular, intravenous | 60505-6144ANDA |
| Cefepime | Cefepime | injection, powder, for solution, intravenous | 60505-6145ANDA |
| Cefepime | Cefepime | injection, powder, for solution, intramuscular, intravenous | 60505-6146ANDA |
| Cefepime | Cefepime | injection, powder, for solution, intravenous | 60505-6147ANDA |
| Cefepime | Cefepime | injection, powder, for solution, intramuscular, intravenous | 60505-6245ANDA |
| Cefepime | Cefepime | injection, powder, for solution, intravenous | 60505-6246ANDA |
| Ceftaroline Fosamil | Ceftaroline Fosamil | injection, powder, lyophilized, for solution, intravenous | 60505-4946ANDA |
| Ceftaroline Fosamil | Ceftaroline Fosamil | injection, powder, lyophilized, for solution, intravenous | 60505-4947ANDA |
| Ceftaroline Fosamil | Ceftaroline Fosamil | injection, powder, lyophilized, for solution, intravenous | 60505-6124ANDA |
| Ceftaroline Fosamil | Ceftaroline Fosamil | injection, powder, lyophilized, for solution, intravenous | 60505-6125ANDA |
| Ceftriaxone Sodium | Ceftriaxone Sodium | injection, powder, for solution, intramuscular, intravenous | 60505-6148ANDA |
| Ceftriaxone Sodium | Ceftriaxone Sodium | injection, powder, for solution, intramuscular, intravenous | 60505-6149ANDA |
| Ceftriaxone Sodium | Ceftriaxone Sodium | injection, powder, for solution, intravenous | 60505-6150ANDA |
| Ceftriaxone Sodium | Ceftriaxone Sodium | injection, powder, for solution, intramuscular, intravenous | 60505-6151ANDA |
| Ceftriaxone Sodium | Ceftriaxone Sodium | injection, powder, for solution, intramuscular, intravenous | 60505-6152ANDA |
| Celecoxib | Celecoxib | capsule, oral | 60505-3848ANDA |
| Celecoxib | Celecoxib | capsule, oral | 60505-3849ANDA |
| Cetrorelix acetate | Cetrorelix Acetate for Injection | kit, subcutaneous | 60505-6270ANDA |
| Cladribine | Cladribine | tablet, oral | 60505-4791ANDA |
| Clopidogrel | clopidogrel bisulfate | tablet, film coated, oral | 60505-0253ANDA |
| Clopidogrel | clopidogrel bisulfate | tablet, film coated, oral | 60505-3532ANDA |
| Clorazepate Dipotassium | Clorazepate Dipotassium | tablet, oral | 60505-4754ANDA |
| Clorazepate Dipotassium | Clorazepate Dipotassium | tablet, oral | 60505-4755ANDA |
| Clorazepate Dipotassium | Clorazepate Dipotassium | tablet, oral | 60505-4756ANDA |
| CycloSPORINE, Modfied | Cyclosporine | capsule, liquid filled, oral | 60505-4630ANDA |
| CycloSPORINE, Modfied | Cyclosporine | capsule, liquid filled, oral | 60505-4631ANDA |
| CycloSPORINE, Modfied | Cyclosporine | capsule, liquid filled, oral | 60505-4632ANDA |
| Cyclosporine | Cyclosporine | capsule, gelatin coated, oral | 60505-0133ANDA |
| Cyclosporine | Cyclosporine | capsule, gelatin coated, oral | 60505-0134ANDA |
| Cyclosporine | Cyclosporine | emulsion, ophthalmic | 60505-6202NDA AUTHORIZED GENERIC |
| - | DABIGATRAN ETEXILATE MESYLATE | powder | 49867-0075BULK INGREDIENT |
| - | DEFERPRONE | powder | 49867-0071BULK INGREDIENT |
| DESMOPRESSIN ACETATE | DESMOPRESSIN ACETATE | spray, nasal | 60505-0815ANDA |
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | capsule, extended release, oral | 60505-0014ANDA |
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | capsule, extended release, oral | 60505-0015ANDA |
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | capsule, extended release, oral | 60505-0016ANDA |
| DROSPIRENONE AND ETHINYL ESTRADIOL | DROSPIRENONE AND ETHINYL ESTRADIOL | kit | 60505-4897ANDA |
| Dapagliflozin | DAPAGLIFLOZIN | tablet, film coated, oral | 60505-4911ANDA |
| Dapagliflozin | DAPAGLIFLOZIN | tablet, film coated, oral | 60505-4912ANDA |
| Daptomycin | Daptomycin | injection, powder, lyophilized, for solution, intravenous | 60505-6229ANDA |
| Dasatinib | Dasatinib | tablet, film coated, oral | 60505-3628ANDA |
| Dasatinib | Dasatinib | tablet, film coated, oral | 60505-3629ANDA |
| Dasatinib | Dasatinib | tablet, film coated, oral | 60505-3630ANDA |
| Dasatinib | Dasatinib | tablet, film coated, oral | 60505-3631ANDA |
| Dasatinib | Dasatinib | tablet, film coated, oral | 60505-3816ANDA |
| Dasatinib | Dasatinib | tablet, film coated, oral | 60505-3817ANDA |
| Deferoxamine mesylate | Deferoxamine mesylate | injection, powder, lyophilized, for solution, intramuscular, intravenous, subcutaneous | 60505-6236ANDA |
| Deferoxamine mesylate | Deferoxamine mesylate | injection, powder, lyophilized, for solution, intramuscular, intravenous | 60505-6237ANDA |
| Desmopressin Acetate | desmopressin acetate | tablet, oral | 60505-0257ANDA |
| Desmopressin Acetate | desmopressin acetate | tablet, oral | 60505-0258ANDA |
| Dexamethasone | Dexamethasone | tablet, oral | 60505-6249ANDA |
| Dexamethasone | Dexamethasone | tablet, oral | 60505-6250ANDA |
| Dexamethasone | Dexamethasone | tablet, oral | 60505-6251ANDA |
| Dexamethasone | Dexamethasone | tablet, oral | 60505-6252ANDA |
| Dexamethasone | Dexamethasone | tablet, oral | 60505-6253ANDA |
| Dexamethasone | Dexamethasone | tablet, oral | 60505-6254ANDA |
| Dexamethasone | Dexamethasone | tablet, oral | 60505-6255ANDA |
| Diclofenac Sodium | Diclofenac Sodium | solution, topical | 60505-0406ANDA |
| Doxazosin | Doxazosin | tablet, oral | 60505-0093ANDA |
| Doxazosin | Doxazosin | tablet, oral | 60505-0094ANDA |
| Doxazosin | Doxazosin | tablet, oral | 60505-0095ANDA |
| Doxazosin | Doxazosin | tablet, oral | 60505-0096ANDA |
| Doxycycline | Doxycycline | capsule, oral | 60505-4775ANDA |
| EVDI | Trabectedin | injection, solution, concentrate, intravenous | 60505-6423NDA |
| Ertapenem | Ertapenem Sodium | injection, intramuscular, intravenous | 60505-6196ANDA |
| Eslicarbazepine Acetate | Eslicarbazepine Acetate | tablet, oral | 60505-4658ANDA |
| Eslicarbazepine Acetate | Eslicarbazepine Acetate | tablet, oral | 60505-4659ANDA |
| Eslicarbazepine Acetate | Eslicarbazepine Acetate | tablet, oral | 60505-4660ANDA |
| Eslicarbazepine Acetate | Eslicarbazepine Acetate | tablet, oral | 60505-4661ANDA |
| Etodolac | Etodolac | capsule, oral | 60505-0039ANDA |
| Etodolac | Etodolac | capsule, oral | 60505-0040ANDA |
| Etodolac | Etodolac | tablet, film coated, oral | 60505-0041ANDA |
| Etodolac | Etodolac | tablet, film coated, oral | 60505-0102ANDA |
| - | FLUTICASONE PROPIONATE | powder | 49867-0076BULK INGREDIENT |
| Fenofibrate | Fenofibrate | capsule, oral | 60505-3120ANDA |
| Fenofibrate | Fenofibrate | capsule, oral | 60505-3121ANDA |
| Fidaxomicin | Fidaxomicin | tablet, film coated, oral | 60505-4833ANDA |
| Fingolimod | Fingolimod | capsule, oral | 60505-4332ANDA |
| Fluticasone Propionate | Fluticasone Propionate | spray, metered, nasal | 60505-0829ANDA |
| Fluticasone Propionate | Fluticasone Propionate | spray, metered, nasal | 60505-0955ANDA |
| Fluticasone Propionate | Fluticasone Propionate | spray, metered, nasal | 60505-6205ANDA |
| - | Fluticasone Propionate | spray, metered | 60505-6420DRUG FOR FURTHER PROCESSING |
| Fluvoxamine Maleate | Fluvoxamine Maleate | tablet, oral | 60505-0164ANDA |
| Fluvoxamine Maleate | Fluvoxamine Maleate | tablet, oral | 60505-0165ANDA |
| Fluvoxamine Maleate | Fluvoxamine Maleate | tablet, oral | 60505-0166ANDA |
Neighbours
Registered in the same town
12- Biocon Biologics LimitedBengaluru, IND · 5 sites
- Micro Labs LimitedBengaluru, IND · 4 sites
- Syngene International LimitedBengaluru, IND · 3 sites
- Viatris Inc.Bangalore, IND; Bengaluru, IND · 2 sites
- CIPLA PHARMACEUTICALS LIMITEDBengaluru, IND · 2 sites
- SHILPA MEDICARE LIMITEDBengaluru, IND · 2 sites
- Anthem Biosciences LimitedBengaluru, IND · 2 sites
- ONESOURCE SPECIALTY PHARMA LIMITEDBengaluru, IND · 2 sites
- R.L.Fine Chem Private LimitedBangalore, IND; Bengaluru, IND · 2 sites
- Deciem IncEtobicoke, CAN; Toronto, CAN · 2 sites
- Eurofins Advinus BioPharma Services India Private LimitedBENGALURU, IND; Bengaluru, IND · 2 sites
- Strides Pharma Science LimitedBengaluru, IND
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Enquiry
Common questions
- Is Apotex Inc. FDA approved?
- Apotex Inc. holds 6 FDA-registered establishments across 2 countries. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
- Where are Apotex Inc.'s drugs manufactured?
- At registered sites in Canada, India. The FDA register lists Brantford; Etobicoke; Richmond Hill; Toronto; Bangalore; Bengaluru. Registered operations: analytical testing, active ingredient (API) manufacture, finished drug manufacture, packaging.
- What drugs does Apotex Inc. make?
- 372 products are listed under Apotex Inc. in the openFDA NDC Directory, most often as tablet; tablet, film coated; capsule. The full breakdown by dosage form and route is above. A listing count is not a sales figure.
- Are any Apotex Inc. products in shortage?
- 8 presentations are currently listed in the FDA drug shortage database under Apotex Inc., covering Desmopressin Acetate Spray, Lisdexamfetamine Dimesylate Capsule.
Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.