Register entryShortage reported
Alembic Pharmaceuticals Limited
- Registered sites
- 7
- Drug products
- 997
- Live patents
- 7
- Countries
- 1
- Base
- India
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 manufacture
Sites
Facilities
7| Site | Location | Operations | FEI |
|---|---|---|---|
| Alembic Pharmaceuticals Limited | PANCHMAHALIndia | Finished drug manufacture | 3004956904 |
| Alembic Pharmaceuticals Limited | PANCHMAHALIndia | Active ingredient (API) manufacture | 3003821360 |
| Alembic Pharmaceuticals Limited | PanchmahalIndia | Finished drug manufacture | 3014866088 |
| Alembic Pharmaceuticals Limited | VADODARAIndia | Active ingredient (API) manufacture | 3007501748 |
| Alembic Pharmaceuticals Limited | VadodaraIndia | Finished drug manufacture | 3016088083 |
| Alembic Pharmaceuticals Limited | VadodaraIndia | Finished drug manufacture | 3015685305 |
| Alembic Pharmaceuticals Limited | VadodaraIndia | Analytical testing, Finished drug manufacture | 3013826490 |
Alert
Products in shortage
3| Drug | Presentation | Availability |
|---|---|---|
| Ketorolac Tromethamine Injection | Ketorolac Tromethamine, Injection, 60 mg/2 mL (NDC 62332-601-25) | Available |
| Ketorolac Tromethamine Injection | Ketorolac Tromethamine, Injection, 30 mg/1 mL (NDC 62332-600-25) | Available |
| Ketorolac Tromethamine Injection | Ketorolac Tromethamine, Injection, 15 mg/1 mL (NDC 62332-599-25) | Available |
Exclusivity
Patents
7Unexpired Orange Book patents where this company is the application holder.
| Product | Active ingredient | Expiry |
|---|---|---|
| NUVESSA | METRONIDAZOLE | Feb 2028 |
| NUVESSA | METRONIDAZOLE | Feb 2028 |
| NUVESSA | METRONIDAZOLE | Jun 2028 |
| NUVESSA | METRONIDAZOLE | Jun 2032 |
Catalogue
Marketed products
997Showing 150 of 997.
| Brand | Generic name | Form | Category |
|---|---|---|---|
| - | ACALABRUTINIB | POWDER | BULK INGREDIENT |
| ACYCLOVIR | ACYCLOVIR | CREAM | ANDA |
| ADAPALENE | ADAPALENE | GEL | ANDA |
| ADAPALENE | ADAPALENE | GEL | ANDA |
| ADAPALENE AND BENZOYL PEROXIDE | adapalene and benzoyl peroxide topical | GEL | ANDA |
| ADAPALENE AND BENZOYL PEROXIDE | adapalene and benzoyl peroxide topical | GEL | ANDA |
| - | ARIPIPRAZOLE | POWDER | BULK INGREDIENT |
| AZELASTINE HYDROCHLORIDE | azelastine hydrochloride | SOLUTION/ DROPS | ANDA |
| AZITHROMYCIN | AZITHROMYCIN | TABLET, FILM COATED | ANDA |
| AZITHROMYCIN | AZITHROMYCIN | TABLET, FILM COATED | ANDA |
| - | AZITHROMYCIN MONOHYDRATE | POWDER | BULK INGREDIENT |
| Acetazolamide | Acetazolamide | CAPSULE, EXTENDED RELEASE | ANDA |
| Acetazolamide | Acetazolamide | CAPSULE, EXTENDED RELEASE | ANDA |
| Acitretin | Acitretin | CAPSULE | ANDA |
| Acitretin | Acitretin | CAPSULE | ANDA |
| Acitretin | Acitretin | CAPSULE | ANDA |
| Acitretin | Acitretin | CAPSULE | ANDA |
| Acitretin | Acitretin | CAPSULE | ANDA |
| Acitretin | Acitretin | CAPSULE | ANDA |
| Acyclovir | Acyclovir | OINTMENT | ANDA |
| - | Afatinib Dimaleate | POWDER | BULK INGREDIENT |
| Albendazole | Albendazole | TABLET, FILM COATED | ANDA |
| Albendazole | Albendazole | TABLET, FILM COATED | ANDA |
| Amantadine | Amantadine | TABLET | ANDA |
| Amantadine | Amantadine | TABLET | 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 |
| 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 |
| 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 Valsartan | Amlodipine and Valsartan | TABLET, FILM COATED | ANDA |
| Amlodipine and Valsartan | Amlodipine and Valsartan | TABLET, FILM COATED | ANDA |
| Amlodipine and Valsartan | Amlodipine and Valsartan | TABLET, FILM COATED | ANDA |
| Amlodipine and Valsartan | Amlodipine and Valsartan | TABLET, FILM COATED | ANDA |
| Amlodipine and Valsartan | Amlodipine and Valsartan | TABLET, FILM COATED | ANDA |
| Amlodipine and Valsartan | Amlodipine and Valsartan | TABLET, FILM COATED | ANDA |
| Amlodipine and Valsartan | Amlodipine and Valsartan | TABLET, FILM COATED | ANDA |
| Amlodipine and Valsartan | Amlodipine and Valsartan | TABLET, FILM COATED | ANDA |
| Amlodipine besylate and Olmesartran medoxomil | Amlodipine besylate and Olmesartran medoxomil | TABLET, FILM COATED | ANDA |
| Amlodipine besylate and Olmesartran medoxomil | Amlodipine besylate and Olmesartran medoxomil | TABLET, FILM COATED | ANDA |
| Amlodipine besylate and Olmesartran medoxomil | Amlodipine besylate and Olmesartran medoxomil | TABLET, FILM COATED | ANDA |
| Amlodipine besylate and Olmesartran medoxomil | Amlodipine besylate and Olmesartran medoxomil | TABLET, FILM COATED | ANDA |
| Amlodipine besylate and Olmesartran medoxomil | Amlodipine besylate and Olmesartran medoxomil | TABLET, FILM COATED | ANDA |
| Amlodipine besylate and Olmesartran medoxomil | Amlodipine besylate and Olmesartran medoxomil | TABLET, FILM COATED | ANDA |
| Amlodipine besylate and Olmesartran medoxomil | Amlodipine besylate and Olmesartran medoxomil | TABLET, FILM COATED | ANDA |
| Amlodipine besylate and Olmesartran medoxomil | Amlodipine besylate and Olmesartran medoxomil | TABLET, FILM COATED | ANDA |
| Arformoterol tartrate | Arformoterol tartrate | SOLUTION | ANDA |
| Aripiprazole | Aripiprazole | TABLET | ANDA |
| Aripiprazole | Aripiprazole | TABLET | ANDA |
| Aripiprazole | Aripiprazole | TABLET | ANDA |
| Aripiprazole | Aripiprazole | TABLET | ANDA |
| Aripiprazole | Aripiprazole | TABLET | ANDA |
| Aripiprazole | Aripiprazole | TABLET | ANDA |
| Aripiprazole | Aripiprazole | TABLET, ORALLY DISINTEGRATING | ANDA |
| Aripiprazole | Aripiprazole | TABLET, ORALLY DISINTEGRATING | ANDA |
| Aripiprazole | Aripiprazole | TABLET | ANDA |
| Aripiprazole | Aripiprazole | TABLET | ANDA |
| Aripiprazole | Aripiprazole | TABLET | ANDA |
| Aripiprazole | Aripiprazole | TABLET | ANDA |
| Aripiprazole | Aripiprazole | TABLET | ANDA |
| Aripiprazole | Aripiprazole | TABLET | ANDA |
| Aripiprazole | Aripiprazole | TABLET, ORALLY DISINTEGRATING | ANDA |
| Aripiprazole | Aripiprazole | TABLET, ORALLY DISINTEGRATING | ANDA |
| Asenapine | Asenapine | TABLET | ANDA |
| Asenapine | Asenapine | TABLET | ANDA |
| Asenapine | Asenapine | TABLET | ANDA |
| Asenapine | Asenapine | TABLET | ANDA |
| Asenapine | Asenapine | TABLET | ANDA |
| Asenapine | Asenapine | TABLET | ANDA |
| Azelastine Hydrochloride Ophthalmic Solution 0.05% | Azelastine Hydrochloride Ophthalmic Solution 0.05% | SOLUTION/ DROPS | ANDA |
| Azithromycin | Azithromycin | TABLET, FILM COATED | ANDA |
| Azithromycin | Azithromycin | TABLET, FILM COATED | ANDA |
| Azithromycin | Azithromycin | TABLET, FILM COATED | ANDA |
| Azithromycin | Azithromycin | TABLET, FILM COATED | ANDA |
| BISOPROLOL FUMARATE | BISOPROLOL FUMARATE | TABLET, FILM COATED | ANDA |
| BISOPROLOL FUMARATE | BISOPROLOL FUMARATE | TABLET, FILM COATED | ANDA |
| BISOPROLOL FUMARATE | BISOPROLOL FUMARATE | TABLET, FILM COATED | ANDA |
| BISOPROLOL FUMARATE | BISOPROLOL FUMARATE | TABLET, FILM COATED | ANDA |
| BROMFENAC SODIUM | BROMFENAC SODIUM | SOLUTION/ DROPS | ANDA |
| BROMFENAC SODIUM | BROMFENAC SODIUM | SOLUTION/ DROPS | ANDA |
| - | BUPROPION HYDROCHLORIDE | POWDER | BULK INGREDIENT |
| Bepotastine Besilate Ophthalmic Solution 1.5% | Bepotastine Besilate Ophthalmic Solution 1.5% | SOLUTION/ DROPS | ANDA |
| Bepotastine Besilate Ophthalmic Solution 1.5% | Bepotastine Besilate Ophthalmic Solution 1.5% | SOLUTION/ DROPS | ANDA |
| Betamethasone valerate | Betamethasone valerate | AEROSOL, FOAM | ANDA |
| Betamethasone valerate | Betamethasone valerate | AEROSOL, FOAM | ANDA |
| Bimatoprost | Bimatoprost | SOLUTION/ DROPS | ANDA |
| Bimatoprost | Bimatoprost | SOLUTION/ DROPS | ANDA |
| Bosutinib | Bosutinib | TABLET, FILM COATED | ANDA |
| Bosutinib | Bosutinib | TABLET, FILM COATED | ANDA |
| Bosutinib | Bosutinib | TABLET, FILM COATED | ANDA |
| Bosutinib | Bosutinib | TABLET, FILM COATED | ANDA |
| Brimonidine Tartrate | Brimonidine Tartrate | SOLUTION/ DROPS | ANDA |
| Brimonidine Tartrate | Brimonidine Tartrate | SOLUTION/ DROPS | ANDA |
| Brimonidine Tartrate and Timolol Maleate | Brimonidine Tartrate and Timolol Maleate | SOLUTION/ DROPS | ANDA |
| Brimonidine Tartrate and Timolol Maleate | Brimonidine Tartrate and Timolol Maleate | SOLUTION/ DROPS | ANDA |
| Brimonidine Tartrate ophthalmic solution, 0.15% | Brimonidine Tartrate ophthalmic solution, 0.15% | SOLUTION/ DROPS | ANDA |
| Brimonidine Tartrate ophthalmic solution, 0.15% | Brimonidine Tartrate ophthalmic solution, 0.15% | SOLUTION/ DROPS | ANDA |
| Bromfenac Ophthalmic Solution 0.09% | Bromfenac Ophthalmic Solution 0.09% | SOLUTION/ DROPS | ANDA |
| Bupropion Hydrochloride | Bupropion Hydrochloride | TABLET, FILM COATED | ANDA |
| Bupropion Hydrochloride | Bupropion Hydrochloride | TABLET, FILM COATED | ANDA |
| Bupropion Hydrochloride | Bupropion Hydrochloride | TABLET, FILM COATED | ANDA |
| Bupropion Hydrochloride | Bupropion Hydrochloride | TABLET, FILM COATED | ANDA |
| - | CANAGLIFLOZIN | POWDER | BULK INGREDIENT |
| CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | TABLET | ANDA |
| CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | TABLET | ANDA |
| CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | TABLET | ANDA |
| CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | TABLET | ANDA |
| CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | TABLET | ANDA |
| CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | TABLET | ANDA |
| CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | TABLET | ANDA |
| CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | TABLET | ANDA |
| CARBAMAZEPINE | CARBAMAZEPINE | TABLET | ANDA |
| CARBAMAZEPINE | CARBAMAZEPINE | TABLET | ANDA |
| CARBOPROST TROMETHAMINE | CARBOPROST TROMETHAMINE | INJECTION, SOLUTION | ANDA |
| CARBOPROST TROMETHAMINE | CARBOPROST TROMETHAMINE | INJECTION, SOLUTION | ANDA |
| CHLORTHALIDONE CHLORTHALIDONE | CHLORTHALIDONE | TABLET | ANDA |
| CHLORTHALIDONE CHLORTHALIDONE | CHLORTHALIDONE | TABLET | ANDA |
| CHLORTHALIDONE CHLORTHALIDONE | CHLORTHALIDONE | TABLET | ANDA |
| CHLORTHALIDONE CHLORTHALIDONE | CHLORTHALIDONE | TABLET | ANDA |
| - | CLARITHROMYCIN | POWDER | BULK INGREDIENT |
| CLINDAMYCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | GEL | ANDA |
| CLINDAMYCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | GEL | ANDA |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | SPRAY | ANDA |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | SOLUTION | ANDA |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | CREAM | ANDA |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | SHAMPOO | ANDA |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | AEROSOL, FOAM | ANDA |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | SPRAY | ANDA |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | SOLUTION | ANDA |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | CREAM | ANDA |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | SHAMPOO | ANDA |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | AEROSOL, FOAM | ANDA |
| CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | CAPSULE | 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.