Register entryShortage reported
- Registered sites
- 7
- Active NDC listings
- 998
- Labeller names
- 3
- Live patents
- 7
- Shortage listings
- 3
- Countries
- 1
- Base
- India
Authorisation
Registered operations
Analytical testing1Active ingredient (API) manufacture2Finished drug manufacture5
Sites
Registered establishments
7| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Alembic Pharmaceuticals Limited | API Division, Village Panelav, P.O. Tajpura, Near Baska, Taluka Halol,, PANCHMAHAL, GUJARAT 389350, India (IND) | Active ingredient (API) manufacture | 3003821360650574705 |
| Alembic Pharmaceuticals Limited | Formulation Division, Village Panelav, P.O. Tajpura, Near Baska, Taluka Halol,, PANCHMAHAL, GUJARAT 389350, India (IND) | Finished drug manufacture | 3004956904650574671 |
| Alembic Pharmaceuticals Limited | Survey No. 84,87 and 88, Panelav, Taluka Halol, Panchmahal, Gujarat 389350, India (IND) | Finished drug manufacture | 3014866088675480402 |
| Alembic Pharmaceuticals Limited | API Division, Plot No 842-843, Village Karakhadi, Padra Taluka, VADODARA, GUJARAT 391450, India (IND) | Active ingredient (API) manufacture | 3007501748650574697 |
| Alembic Pharmaceuticals Limited | Derma Division, Plot no 779/P and 790/P, Vadodara, Gujarat 391450, India (IND) | Analytical testing, Finished drug manufacture | 3013826490871411532 |
| Alembic Pharmaceuticals Limited | Formulation Division III, Plot No. 779P/790P, Village - Karakhadi, Taluka - Padra, Vadodara, Gujarat 391450, India (IND) | Finished drug manufacture | 3015685305675480734 |
| Alembic Pharmaceuticals Limited | Formulation Division IV, Halol Road, Jarod, Taluka Waghodia, Vadodara, Gujarat 391510, India (IND) | Finished drug manufacture | 3016088083675469976 |
Alert
Drug shortage listings
3| Drug | Presentation | Status | Availability | Posted / updated |
|---|---|---|---|---|
| Ketorolac Tromethamine InjectionAnalgesia/Addiction | Ketorolac Tromethamine, Injection, 60 mg/2 mL (NDC 62332-601-25) | Current | Available | 23 Mar 201815 May 2026 |
| Ketorolac Tromethamine InjectionAnalgesia/Addiction | Ketorolac Tromethamine, Injection, 30 mg/1 mL (NDC 62332-600-25) | Current | Available | 23 Mar 201815 May 2026 |
| Ketorolac Tromethamine InjectionAnalgesia/Addiction | Ketorolac Tromethamine, Injection, 15 mg/1 mL (NDC 62332-599-25) | Current | Available | 23 Mar 201815 May 2026 |
Catalogue
Drug listings by form and route
998998 active NDC listings: 971 human prescription drug, 20 bulk ingredient, 7 human otc drug. By marketing category: ANDA 975, BULK INGREDIENT 20, NDA 3.
| Dosage form | NDCs |
|---|---|
| tablet, film coated | 290 |
| tablet | 181 |
| capsule | 140 |
| tablet, extended release | 65 |
| solution/ drops | 40 |
| tablet, orally disintegrating | 28 |
| capsule, extended release | 26 |
| tablet, coated | 25 |
| injection | 24 |
| tablet, film coated, extended release | 23 |
| powder | 20 |
| cream | 19 |
| injection, solution | 17 |
| capsule, delayed release | 16 |
| gel | 15 |
| Route | NDCs |
|---|---|
| oral | 808 |
| topical | 57 |
| ophthalmic | 44 |
| intravenous | 40 |
| intramuscular | 24 |
| subcutaneous | 16 |
| intra-articular | 6 |
| sublingual | 6 |
| intrathecal | 2 |
| respiratory (inhalation) | 2 |
| cutaneous | 1 |
| transdermal | 1 |
| Labeller name on the listing | NDCs |
|---|---|
| alembic pharmaceuticals limited | 502 |
| alembic pharmaceuticals inc. | 492 |
| alembic labs llc | 4 |
Exclusivity
Patents and exclusivities
7| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 8877792 | NUVESSAmetronidazole | product | Feb 2028 |
| 7893097 | NUVESSAmetronidazole | product | Feb 2028 |
| 8658678 | NUVESSAmetronidazole | use | Jun 2028 |
| 10238634 | NUVESSAmetronidazole | product | Jun 2032 |
| 10596155 | NUVESSAmetronidazole | product | Jun 2032 |
| 8946276 | NUVESSAmetronidazole | use | Jun 2032 |
| 9198858 | NUVESSAmetronidazole | use | Jun 2032 |
Catalogue
Marketed products
998Showing 150 of 998.
| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| - | ACALABRUTINIB | powder | 46708-942BULK INGREDIENT |
| ACYCLOVIR | ACYCLOVIR | cream, topical | 62332-423ANDA |
| ADAPALENE | ADAPALENE | gel, topical | 46708-549ANDA |
| ADAPALENE | ADAPALENE | gel, topical | 62332-549ANDA |
| ADAPALENE AND BENZOYL PEROXIDE | adapalene and benzoyl peroxide topical | gel, topical | 46708-662ANDA |
| ADAPALENE AND BENZOYL PEROXIDE | adapalene and benzoyl peroxide topical | gel, topical | 62332-662ANDA |
| - | ARIPIPRAZOLE | powder | 46708-837BULK INGREDIENT |
| AZELASTINE HYDROCHLORIDE | azelastine hydrochloride | solution/ drops, ophthalmic | 46708-506ANDA |
| AZITHROMYCIN | AZITHROMYCIN | tablet, film coated, oral | 46708-253ANDA |
| AZITHROMYCIN | AZITHROMYCIN | tablet, film coated, oral | 62332-253ANDA |
| - | AZITHROMYCIN MONOHYDRATE | powder | 46708-866BULK INGREDIENT |
| Acetazolamide | Acetazolamide | capsule, extended release, oral | 46708-349ANDA |
| Acetazolamide | Acetazolamide | capsule, extended release, oral | 62332-349ANDA |
| Acitretin | Acitretin | capsule, oral | 46708-741ANDA |
| Acitretin | Acitretin | capsule, oral | 46708-742ANDA |
| Acitretin | Acitretin | capsule, oral | 46708-743ANDA |
| Acitretin | Acitretin | capsule, oral | 62332-741ANDA |
| Acitretin | Acitretin | capsule, oral | 62332-742ANDA |
| Acitretin | Acitretin | capsule, oral | 62332-743ANDA |
| Acyclovir | Acyclovir | ointment, cutaneous | 62332-248ANDA |
| - | Afatinib Dimaleate | powder | 46708-895BULK INGREDIENT |
| Albendazole | Albendazole | tablet, film coated, oral | 46708-681ANDA |
| Albendazole | Albendazole | tablet, film coated, oral | 62332-681ANDA |
| Amantadine | Amantadine | tablet, oral | 46708-586ANDA |
| Amantadine | Amantadine | tablet, oral | 62332-586ANDA |
| Amlodipine and Atorvastatin | Amlodipine and Atorvastatin | tablet, film coated, oral | 46708-755ANDA |
| Amlodipine and Atorvastatin | Amlodipine and Atorvastatin | tablet, film coated, oral | 46708-756ANDA |
| Amlodipine and Atorvastatin | Amlodipine and Atorvastatin | tablet, film coated, oral | 46708-757ANDA |
| Amlodipine and Atorvastatin | Amlodipine and Atorvastatin | tablet, film coated, oral | 46708-758ANDA |
| Amlodipine and Atorvastatin | Amlodipine and Atorvastatin | tablet, film coated, oral | 46708-759ANDA |
| Amlodipine and Atorvastatin | Amlodipine and Atorvastatin | tablet, film coated, oral | 46708-760ANDA |
| Amlodipine and Atorvastatin | Amlodipine and Atorvastatin | tablet, film coated, oral | 46708-761ANDA |
| Amlodipine and Atorvastatin | Amlodipine and Atorvastatin | tablet, film coated, oral | 46708-762ANDA |
| Amlodipine and Atorvastatin | Amlodipine and Atorvastatin | tablet, film coated, oral | 46708-763ANDA |
| Amlodipine and Atorvastatin | Amlodipine and Atorvastatin | tablet, film coated, oral | 46708-764ANDA |
| Amlodipine and Atorvastatin | Amlodipine and Atorvastatin | tablet, film coated, oral | 46708-765ANDA |
| Amlodipine and Atorvastatin | Amlodipine and Atorvastatin | tablet, film coated, oral | 62332-755ANDA |
| Amlodipine and Atorvastatin | Amlodipine and Atorvastatin | tablet, film coated, oral | 62332-756ANDA |
| Amlodipine and Atorvastatin | Amlodipine and Atorvastatin | tablet, film coated, oral | 62332-757ANDA |
| Amlodipine and Atorvastatin | Amlodipine and Atorvastatin | tablet, film coated, oral | 62332-758ANDA |
| Amlodipine and Atorvastatin | Amlodipine and Atorvastatin | tablet, film coated, oral | 62332-759ANDA |
| Amlodipine and Atorvastatin | Amlodipine and Atorvastatin | tablet, film coated, oral | 62332-760ANDA |
| Amlodipine and Atorvastatin | Amlodipine and Atorvastatin | tablet, film coated, oral | 62332-761ANDA |
| Amlodipine and Atorvastatin | Amlodipine and Atorvastatin | tablet, film coated, oral | 62332-762ANDA |
| Amlodipine and Atorvastatin | Amlodipine and Atorvastatin | tablet, film coated, oral | 62332-763ANDA |
| Amlodipine and Atorvastatin | Amlodipine and Atorvastatin | tablet, film coated, oral | 62332-764ANDA |
| Amlodipine and Atorvastatin | Amlodipine and Atorvastatin | tablet, film coated, oral | 62332-765ANDA |
| Amlodipine and Valsartan | Amlodipine and Valsartan | tablet, film coated, oral | 46708-458ANDA |
| Amlodipine and Valsartan | Amlodipine and Valsartan | tablet, film coated, oral | 46708-459ANDA |
| Amlodipine and Valsartan | Amlodipine and Valsartan | tablet, film coated, oral | 46708-460ANDA |
| Amlodipine and Valsartan | Amlodipine and Valsartan | tablet, film coated, oral | 46708-461ANDA |
| Amlodipine and Valsartan | Amlodipine and Valsartan | tablet, film coated, oral | 62332-205ANDA |
| Amlodipine and Valsartan | Amlodipine and Valsartan | tablet, film coated, oral | 62332-206ANDA |
| Amlodipine and Valsartan | Amlodipine and Valsartan | tablet, film coated, oral | 62332-207ANDA |
| Amlodipine and Valsartan | Amlodipine and Valsartan | tablet, film coated, oral | 62332-208ANDA |
| Amlodipine besylate and Olmesartran medoxomil | Amlodipine besylate and Olmesartran medoxomil | tablet, film coated, oral | 46708-212ANDA |
| Amlodipine besylate and Olmesartran medoxomil | Amlodipine besylate and Olmesartran medoxomil | tablet, film coated, oral | 46708-213ANDA |
| Amlodipine besylate and Olmesartran medoxomil | Amlodipine besylate and Olmesartran medoxomil | tablet, film coated, oral | 46708-214ANDA |
| Amlodipine besylate and Olmesartran medoxomil | Amlodipine besylate and Olmesartran medoxomil | tablet, film coated, oral | 46708-215ANDA |
| Amlodipine besylate and Olmesartran medoxomil | Amlodipine besylate and Olmesartran medoxomil | tablet, film coated, oral | 62332-212ANDA |
| Amlodipine besylate and Olmesartran medoxomil | Amlodipine besylate and Olmesartran medoxomil | tablet, film coated, oral | 62332-213ANDA |
| Amlodipine besylate and Olmesartran medoxomil | Amlodipine besylate and Olmesartran medoxomil | tablet, film coated, oral | 62332-214ANDA |
| Amlodipine besylate and Olmesartran medoxomil | Amlodipine besylate and Olmesartran medoxomil | tablet, film coated, oral | 62332-215ANDA |
| Arformoterol tartrate | Arformoterol tartrate | solution, respiratory (inhalation) | 62332-633ANDA |
| Aripiprazole | Aripiprazole | tablet, oral | 46708-254ANDA |
| Aripiprazole | Aripiprazole | tablet, oral | 46708-255ANDA |
| Aripiprazole | Aripiprazole | tablet, oral | 46708-256ANDA |
| Aripiprazole | Aripiprazole | tablet, oral | 46708-257ANDA |
| Aripiprazole | Aripiprazole | tablet, oral | 46708-258ANDA |
| Aripiprazole | Aripiprazole | tablet, oral | 46708-259ANDA |
| Aripiprazole | Aripiprazole | tablet, orally disintegrating, oral | 46708-260ANDA |
| Aripiprazole | Aripiprazole | tablet, orally disintegrating, oral | 46708-261ANDA |
| Aripiprazole | Aripiprazole | tablet, oral | 62332-097ANDA |
| Aripiprazole | Aripiprazole | tablet, oral | 62332-098ANDA |
| Aripiprazole | Aripiprazole | tablet, oral | 62332-099ANDA |
| Aripiprazole | Aripiprazole | tablet, oral | 62332-100ANDA |
| Aripiprazole | Aripiprazole | tablet, oral | 62332-101ANDA |
| Aripiprazole | Aripiprazole | tablet, oral | 62332-102ANDA |
| Aripiprazole | Aripiprazole | tablet, orally disintegrating, oral | 62332-103ANDA |
| Aripiprazole | Aripiprazole | tablet, orally disintegrating, oral | 62332-104ANDA |
| Asenapine | Asenapine | tablet, sublingual | 46708-198ANDA |
| Asenapine | Asenapine | tablet, sublingual | 46708-199ANDA |
| Asenapine | Asenapine | tablet, sublingual | 46708-544ANDA |
| Asenapine | Asenapine | tablet, sublingual | 62332-198ANDA |
| Asenapine | Asenapine | tablet, sublingual | 62332-199ANDA |
| Asenapine | Asenapine | tablet, sublingual | 62332-544ANDA |
| Azelastine Hydrochloride Ophthalmic Solution 0.05% | Azelastine Hydrochloride Ophthalmic Solution 0.05% | solution/ drops, ophthalmic | 62332-506ANDA |
| Azithromycin | Azithromycin | tablet, film coated, oral | 46708-057ANDA |
| Azithromycin | Azithromycin | tablet, film coated, oral | 46708-058ANDA |
| Azithromycin | Azithromycin | tablet, film coated, oral | 62332-251ANDA |
| Azithromycin | Azithromycin | tablet, film coated, oral | 62332-252ANDA |
| BISOPROLOL FUMARATE | BISOPROLOL FUMARATE | tablet, film coated, oral | 46708-603ANDA |
| BISOPROLOL FUMARATE | BISOPROLOL FUMARATE | tablet, film coated, oral | 46708-604ANDA |
| BISOPROLOL FUMARATE | BISOPROLOL FUMARATE | tablet, film coated, oral | 62332-603ANDA |
| BISOPROLOL FUMARATE | BISOPROLOL FUMARATE | tablet, film coated, oral | 62332-604ANDA |
| BROMFENAC SODIUM | BROMFENAC SODIUM | solution/ drops, ophthalmic | 46708-583ANDA |
| BROMFENAC SODIUM | BROMFENAC SODIUM | solution/ drops, ophthalmic | 62332-583ANDA |
| - | BUPROPION HYDROCHLORIDE | powder | 46708-843BULK INGREDIENT |
| Bepotastine Besilate Ophthalmic Solution 1.5% | Bepotastine Besilate Ophthalmic Solution 1.5% | solution/ drops, ophthalmic | 46708-598ANDA |
| Bepotastine Besilate Ophthalmic Solution 1.5% | Bepotastine Besilate Ophthalmic Solution 1.5% | solution/ drops, ophthalmic | 62332-598ANDA |
| Betamethasone valerate | Betamethasone valerate | aerosol, foam, topical | 46708-708ANDA |
| Betamethasone valerate | Betamethasone valerate | aerosol, foam, topical | 62332-708ANDA |
| Bimatoprost | Bimatoprost | solution/ drops, ophthalmic | 46708-507ANDA |
| Bimatoprost | Bimatoprost | solution/ drops, ophthalmic | 62332-507ANDA |
| Bosutinib | Bosutinib | tablet, film coated, oral | 46708-311ANDA |
| Bosutinib | Bosutinib | tablet, film coated, oral | 46708-312ANDA |
| Bosutinib | Bosutinib | tablet, film coated, oral | 62332-311ANDA |
| Bosutinib | Bosutinib | tablet, film coated, oral | 62332-312ANDA |
| Brimonidine Tartrate | Brimonidine Tartrate | solution/ drops, ophthalmic | 46708-749ANDA |
| Brimonidine Tartrate | Brimonidine Tartrate | solution/ drops, ophthalmic | 62332-749ANDA |
| Brimonidine Tartrate and Timolol Maleate | Brimonidine Tartrate and Timolol Maleate | solution/ drops, ophthalmic | 46708-706ANDA |
| Brimonidine Tartrate and Timolol Maleate | Brimonidine Tartrate and Timolol Maleate | solution/ drops, ophthalmic | 62332-706ANDA |
| Brimonidine Tartrate ophthalmic solution, 0.15% | Brimonidine Tartrate ophthalmic solution, 0.15% | solution/ drops, ophthalmic | 46708-661ANDA |
| Brimonidine Tartrate ophthalmic solution, 0.15% | Brimonidine Tartrate ophthalmic solution, 0.15% | solution/ drops, ophthalmic | 62332-661ANDA |
| Bromfenac Ophthalmic Solution 0.09% | Bromfenac Ophthalmic Solution 0.09% | solution/ drops, ophthalmic | 62332-508ANDA |
| Bupropion Hydrochloride | Bupropion Hydrochloride | tablet, film coated, oral | 46708-118ANDA |
| Bupropion Hydrochloride | Bupropion Hydrochloride | tablet, film coated, oral | 46708-127ANDA |
| Bupropion Hydrochloride | Bupropion Hydrochloride | tablet, film coated, oral | 62332-118ANDA |
| Bupropion Hydrochloride | Bupropion Hydrochloride | tablet, film coated, oral | 62332-127ANDA |
| - | CANAGLIFLOZIN | powder | 46708-886BULK INGREDIENT |
| CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | tablet, oral | 46708-060ANDA |
| CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | tablet, oral | 46708-341ANDA |
| CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | tablet, oral | 46708-342ANDA |
| CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | tablet, oral | 46708-343ANDA |
| CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | tablet, oral | 62332-060ANDA |
| CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | tablet, oral | 62332-341ANDA |
| CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | tablet, oral | 62332-342ANDA |
| CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | tablet, oral | 62332-343ANDA |
| CARBAMAZEPINE | CARBAMAZEPINE | tablet, oral | 46708-731ANDA |
| CARBAMAZEPINE | CARBAMAZEPINE | tablet, oral | 62332-731ANDA |
| CARBOPROST TROMETHAMINE | CARBOPROST TROMETHAMINE | injection, solution, intramuscular | 46708-777ANDA |
| CARBOPROST TROMETHAMINE | CARBOPROST TROMETHAMINE | injection, solution, intramuscular | 62332-777ANDA |
| CHLORTHALIDONE CHLORTHALIDONE | CHLORTHALIDONE | tablet, oral | 46708-676ANDA |
| CHLORTHALIDONE CHLORTHALIDONE | CHLORTHALIDONE | tablet, oral | 46708-677ANDA |
| CHLORTHALIDONE CHLORTHALIDONE | CHLORTHALIDONE | tablet, oral | 62332-676ANDA |
| CHLORTHALIDONE CHLORTHALIDONE | CHLORTHALIDONE | tablet, oral | 62332-677ANDA |
| - | CLARITHROMYCIN | powder | 46708-839BULK INGREDIENT |
| CLINDAMYCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | gel, topical | 46708-623ANDA |
| CLINDAMYCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | gel, topical | 62332-623ANDA |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | spray, topical | 46708-425ANDA |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | solution, topical | 46708-486ANDA |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | cream, topical | 46708-547ANDA |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | shampoo, topical | 46708-548ANDA |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | aerosol, foam, topical | 46708-707ANDA |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | spray, topical | 62332-425ANDA |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | solution, topical | 62332-486ANDA |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | cream, topical | 62332-547ANDA |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | shampoo, topical | 62332-548ANDA |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | aerosol, foam, topical | 62332-707ANDA |
| CLOMIPRAMINE HYDROCHLORIDE | CLOMIPRAMINE HYDROCHLORIDE | capsule, oral | 46708-407ANDA |
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Enquiry
Common questions
- Is Alembic Pharmaceuticals Limited FDA approved?
- Alembic Pharmaceuticals Limited holds 7 FDA-registered establishments in India. 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 Alembic Pharmaceuticals Limited's drugs manufactured?
- The FDA register lists PANCHMAHAL; Panchmahal; VADODARA; Vadodara. Registered operations: analytical testing, active ingredient (API) manufacture, finished drug manufacture.
- What drugs does Alembic Pharmaceuticals Limited make?
- 998 products are listed under Alembic Pharmaceuticals Limited in the openFDA NDC Directory, most often as tablet, film coated; tablet; capsule. The full breakdown by dosage form and route is above. A listing count is not a sales figure.
- Are any Alembic Pharmaceuticals Limited products in shortage?
- 3 presentations are currently listed in the FDA drug shortage database under Alembic Pharmaceuticals Limited, covering Ketorolac Tromethamine Injection.
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.