Register entry
- Registered sites
- 7
- Active NDC listings
- 368
- Labeller names
- 10
- Live patents
- 6
- Exclusivities
- 1
- Shortage listings
- 1
- Countries
- 1
- Base
- India
Authorisation
Registered operations
Analytical testing7Active ingredient (API) manufacture5Labelling4Finished drug manufacture4Packaging4
Sites
Registered establishments
7| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| CIPLA LIMITED | Virgonagar, Old Madras Road, Bengaluru, Karnataka 560049, India (IND) | Analytical testing, Active ingredient (API) manufacture | 3002806691915154892 |
| CIPLA LIMITED | 285, 286, 287, KIADB, IV Phase, Industrial area Bommasandra-Jigani Link Road, Bengaluru, Karnataka 560105, India (IND) | Analytical testing, Active ingredient (API) manufacture | 3005857289650442440 |
| CIPLA LIMITED | Plot No. 9 &10 Indore Special Economic Zone, Phase II - Pithampur, District Dhar, Indore, Madhya Pradesh 454775, India (IND) | Analytical testing, Labelling, Finished drug manufacture, Packaging | 3008581988918596409 |
| CIPLA LIMITED | Plot D-7, D-22, D-27 MIDC Industrial Area, Kurkumbh Village, Taluka-Daund, Pune, Maharashtra 413802, India (IND) | Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging | 3002806702917066446 |
| CIPLA PHARMACEUTICALS LIMITED | D-8, MIDC ROAD, Kurkumbh MIDC, Pune, Maharashtra 413802, India (IND) | Analytical testing, Active ingredient (API) manufacture | 3037146694766401589 |
| CIPLA LIMITED | Plot No. A-2, A-33, A-42 and A-37/2/2, Patalganga Industrial Area, Raigad, Maharashtra 410220, India (IND) | Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging | 3002806710916940208 |
| CIPLA LIMITED | L-139 to L-146, S-103 to S-105, S-107 to S-112, L-147 to L-147/1/2/3 L-147A, L-138, L-150, S-116, Verna Industrial Estate, Salcette, Goa 403722, India (IND) | Analytical testing, Labelling, Finished drug manufacture, Packaging | 3004081307650072015 |
Alert
Drug shortage listings
1| Drug | Presentation | Status | Availability | Posted / updated |
|---|---|---|---|---|
| Hydrocortisone Sodium Succinate InjectionDermatology, Endocrinology/Metabolism, Gastroenterology, Hematology, Neurology, Oncology, Ophthalmology, Pediatric, Pulmonary/Allergy, Renal, Rheumatology | Hydrocortisone Sodium Succinate, Injection, 100 mg/ Vial (NDC 69097-004-67) | Resolved | - | 24 Mar 202324 Feb 2026 |
Catalogue
Drug listings by form and route
368368 active NDC listings: 269 human prescription drug, 98 bulk ingredient, 1 human otc drug. By marketing category: ANDA 258, BULK INGREDIENT 98, NDA 9, BLA 2, NDA AUTHORIZED GENERIC 1.
| Dosage form | NDCs |
|---|---|
| powder | 101 |
| tablet | 80 |
| capsule | 51 |
| tablet, film coated | 47 |
| injection | 20 |
| tablet, extended release | 16 |
| injection, solution | 6 |
| for suspension | 5 |
| solution | 5 |
| inhalant | 4 |
| granule | 3 |
| injection, emulsion | 3 |
| kit | 3 |
| suspension | 3 |
| tablet, chewable | 3 |
| Route | NDCs |
|---|---|
| oral | 222 |
| intravenous | 17 |
| subcutaneous | 17 |
| intramuscular | 10 |
| respiratory (inhalation) | 8 |
| topical | 3 |
| intracardiac | 2 |
| nasal | 2 |
| ophthalmic | 2 |
| Labeller name on the listing | NDCs |
|---|---|
| cipla usa inc. | 214 |
| cipla ltd. | 97 |
| cipla usa, inc. | 20 |
| cipla usa inc., | 15 |
| cipla usa inc. | 8 |
| cipla usa inc., | 8 |
| cipla usa., inc. | 3 |
| cipla limited | 1 |
| cipla therapeutics inc. | 1 |
| cipla usa, inc | 1 |
Exclusivity
Patents and exclusivities
6| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 7589106 | ARGATROBAN IN SODIUM CHLORIDEargatroban | product | Sept 2027 |
| 7687516 | ARGATROBAN IN SODIUM CHLORIDEargatroban | product | Sept 2027 |
| 8822424 | ZEMDRIplazomicin sulfate | product | Nov 2028 |
| 9266919 | ZEMDRIplazomicin sulfate | use | Nov 2028 |
| 9688711 | ZEMDRIplazomicin sulfate | substance | Nov 2028 |
| 8383596 | ZEMDRIplazomicin sulfate | substance | Jun 2032 |
| Product | Exclusivity | Until |
|---|---|---|
| ZEMDRIPLAZOMICIN SULFATE | GAIN Qualified infectious disease product (GAIN) | Jun 2028 |
Catalogue
Marketed products
368Showing 150 of 368.
| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| - | ACALABRUTINIB | powder | 53104-7746BULK INGREDIENT |
| ALBUTEROL SULFATE | albuterol sulfate | inhalant, respiratory (inhalation) | 69097-142ANDA |
| ALENDRONATE SODIUM | Alendronate sodium | tablet, oral | 69097-223ANDA |
| ALENDRONATE SODIUM | Alendronate sodium | tablet, oral | 69097-224ANDA |
| AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | tablet, oral | 69097-126ANDA |
| AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | tablet, oral | 69097-127ANDA |
| AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | tablet, oral | 69097-128ANDA |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | tablet, film coated, oral | 69097-897ANDA |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | tablet, film coated, oral | 69097-898ANDA |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | tablet, film coated, oral | 69097-899ANDA |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | tablet, film coated, oral | 69097-911ANDA |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | tablet, film coated, oral | 69097-944ANDA |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | tablet, film coated, oral | 69097-945ANDA |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | tablet, film coated, oral | 69097-946ANDA |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | tablet, film coated, oral | 69097-947ANDA |
| Abacavir | Abacavir | tablet, film coated, oral | 69097-514ANDA |
| - | Abacavir Sulfate | powder | 53104-7558BULK INGREDIENT |
| Abacavir and Lamivudine | Abacavir and lamivudine | tablet, film coated, oral | 69097-362ANDA |
| - | Albendazole | powder | 53104-7736BULK INGREDIENT |
| Albuterol | Albuterol Sulfate | aerosol, metered, respiratory (inhalation) | 69097-021ANDA |
| - | Albuterol Sulfate | powder | 53104-7506BULK INGREDIENT |
| - | Alendronate Sodium | powder | 53104-7525BULK INGREDIENT |
| Alfuzosin Hydrochloride extended release | Alfuzosin Hydrochloride | tablet, oral | 69097-844ANDA |
| - | Ambrisentan | powder | 53104-7702BULK INGREDIENT |
| Ambrisentan | Ambrisentan | tablet, film coated, oral | 69097-386ANDA |
| Ambrisentan | Ambrisentan | tablet, film coated, oral | 69097-387ANDA |
| - | Amlodipine Besylate | powder | 53104-7561BULK INGREDIENT |
| Amlodipine Besylate | Amlodipine Besylate | tablet, oral | 69097-836ANDA |
| Amlodipine Besylate | Amlodipine Besylate | tablet, oral | 69097-837ANDA |
| Amlodipine Besylate | Amlodipine Besylate | tablet, oral | 69097-838ANDA |
| Amoxicillin and Clavulanate potassium | Amoxicillin and Clavulanate Potassium | suspension, oral | 69097-098ANDA |
| - | Anagrelide Hydrochloride | powder | 53104-7537BULK INGREDIENT |
| - | Arformoterol Tartrate | powder | 53104-7731BULK INGREDIENT |
| - | Atazanavir Sulfate | powder | 53104-7682BULK INGREDIENT |
| BUPROPION HYDROCHLORIDE (SR) | Bupropion Hydrochloride | tablet, extended release, oral | 69097-877ANDA |
| BUPROPION HYDROCHLORIDE (SR) | Bupropion Hydrochloride | tablet, extended release, oral | 69097-878ANDA |
| BUPROPION HYDROCHLORIDE (SR) | Bupropion Hydrochloride | tablet, extended release, oral | 69097-879ANDA |
| - | Beclomethasone Dipropionate | powder | 53104-7632BULK INGREDIENT |
| Benztropine Mesylate | Benztropine | tablet, oral | 69097-826ANDA |
| Benztropine Mesylate | Benztropine | tablet, oral | 69097-827ANDA |
| Benztropine Mesylate | Benztropine | tablet, oral | 69097-832ANDA |
| - | Bosentan | powder | 53104-7703BULK INGREDIENT |
| - | Budesonide | powder | 53104-7617BULK INGREDIENT |
| Budesonide Inhalation Suspension | Budesonide | inhalant, oral | 69097-318ANDA |
| Budesonide Inhalation Suspension | Budesonide | inhalant, oral | 69097-319ANDA |
| Budesonide Inhalation Suspension | Budesonide | inhalant, oral | 69097-321ANDA |
| Bupropion Hydrochloride | Bupropion hydrochloride | tablet, film coated, extended release, oral | 69097-071ANDA |
| Bupropion Hydrochloride | Bupropion hydrochloride | tablet, film coated, extended release, oral | 69097-072ANDA |
| Bupropion Hydrochloride (XL) | bupropion hydrochloride | tablet, extended release, oral | 69097-875ANDA |
| Bupropion Hydrochloride (XL) | bupropion hydrochloride | tablet, extended release, oral | 69097-876ANDA |
| - | CABOTEGRAVIR | powder | 53104-7740BULK INGREDIENT |
| - | CABOTEGRAVIR SODIUM | powder | 53104-7741BULK INGREDIENT |
| CALCITONIN SALMON | CALCITONIN SALMON | injection, solution, intramuscular, subcutaneous | 69097-770ANDA |
| CELECOXIB | CELECOXIB | capsule, oral | 69097-420ANDA |
| CELECOXIB | CELECOXIB | capsule, oral | 69097-421ANDA |
| CELECOXIB | CELECOXIB | capsule, oral | 69097-422ANDA |
| CELECOXIB | CELECOXIB | capsule, oral | 69097-423ANDA |
| - | CICLESONIDE | powder | 53104-7633BULK INGREDIENT |
| CINACALCET | CINACALCET | tablet, oral | 69097-410ANDA |
| CINACALCET | CINACALCET | tablet, oral | 69097-411ANDA |
| CINACALCET | CINACALCET | tablet, oral | 69097-412ANDA |
| Calcium Acetate | Calcium Acetate | capsule, oral | 69097-862ANDA |
| Capecitabine | Capecitabine | tablet, film coated, oral | 69097-948ANDA |
| Capecitabine | Capecitabine | tablet, film coated, oral | 69097-949ANDA |
| - | Carboplatin | powder | 53104-7570BULK INGREDIENT |
| - | Celecoxib | powder | 53104-7533BULK INGREDIENT |
| - | Cetirizine Hydrochloride | powder | 53104-7528BULK INGREDIENT |
| - | Cinacalcet Hydrochloride | powder | 53104-7699BULK INGREDIENT |
| Citalopram | Citalopram | tablet, oral | 69097-822ANDA |
| Citalopram | Citalopram | tablet, oral | 69097-823ANDA |
| Citalopram | Citalopram | tablet, oral | 69097-824ANDA |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine | tablet, film coated, oral | 69097-845ANDA |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine | tablet, film coated, oral | 69097-846ANDA |
| Cyclophosphamide | Cyclophosphamide | capsule, oral | 69097-516ANDA |
| Cyclophosphamide | Cyclophosphamide | capsule, oral | 69097-517ANDA |
| Cyclosporine | Cyclosporine | emulsion, ophthalmic | 69097-292ANDA |
| DAPAGLIFLOZIN | DAPAGLIFLOZIN | tablet, film coated, oral | 69097-388ANDA |
| DAPAGLIFLOZIN | DAPAGLIFLOZIN | tablet, film coated, oral | 69097-389ANDA |
| DIFLUPREDNATE | DIFLUPREDNATE | emulsion, ophthalmic | 69097-341ANDA |
| DILTIAZEM HYDROCHLORIDE | diltiazem hydrochloride | tablet, extended release, oral | 69097-992ANDA |
| DILTIAZEM HYDROCHLORIDE | diltiazem hydrochloride | tablet, extended release, oral | 69097-993ANDA |
| DILTIAZEM HYDROCHLORIDE | diltiazem hydrochloride | tablet, extended release, oral | 69097-994ANDA |
| DILTIAZEM HYDROCHLORIDE | diltiazem hydrochloride | tablet, extended release, oral | 69097-995ANDA |
| DILTIAZEM HYDROCHLORIDE | diltiazem hydrochloride | tablet, extended release, oral | 69097-996ANDA |
| DILTIAZEM HYDROCHLORIDE | diltiazem hydrochloride | tablet, extended release, oral | 69097-997ANDA |
| DIMETHYL FUMARATE | DIMETHYL FUMARATE | capsule, delayed release, oral | 69097-322ANDA |
| DIMETHYL FUMARATE | DIMETHYL FUMARATE | capsule, delayed release, oral | 69097-323ANDA |
| DIMETHYL FUMARATE | DIMETHYL FUMARATE | kit | 69097-552ANDA |
| - | Danazol | powder | 53104-7501BULK INGREDIENT |
| Darifenacin | Darifenacin Hydrobromide | tablet, extended release, oral | 69097-431ANDA |
| Darifenacin | Darifenacin Hydrobromide | tablet, extended release, oral | 69097-432ANDA |
| - | Darifenacin Hydrobromide | powder | 53104-7706BULK INGREDIENT |
| - | Darunavir | powder | 53104-7694BULK INGREDIENT |
| Darunavir 600 and 800 mg | darunavir | tablet, oral | 69097-244ANDA |
| Darunavir 600 and 800 mg | darunavir | tablet, oral | 69097-248ANDA |
| - | Darunavir Ethanolate | powder | 53104-7693BULK INGREDIENT |
| - | Darunavir Hydrate | powder | 53104-7695BULK INGREDIENT |
| - | Dasatinib | powder | 53104-7725BULK INGREDIENT |
| - | Deferasirox | powder | 53104-7713BULK INGREDIENT |
| Deferasirox | Deferasirox | granule, oral | 69097-550ANDA |
| Deferasirox | Deferasirox | granule, oral | 69097-560ANDA |
| Deferasirox | Deferasirox | granule, oral | 69097-570ANDA |
| Diclofenac sodium | Diclofenac sodium | gel, topical | 69097-720ANDA |
| Dihydroergotamine Mesylate Nasal | Dihydroergotamine Mesylate Nasal | spray, metered, nasal | 69097-503ANDA |
| - | Donepezil Hydrochloride | powder | 53104-7729BULK INGREDIENT |
| - | EDARAVONE | powder | 53104-7744BULK INGREDIENT |
| - | ELIGLUSTAT TARTRATE | powder | 53104-7735BULK INGREDIENT |
| EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | tablet, film coated, oral | 69097-209ANDA |
| EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | tablet, film coated, oral | 69097-741ANDA |
| ENTECAVIR | ENTECAVIR | tablet, film coated, oral | 69097-425ANDA |
| ENTECAVIR | ENTECAVIR | tablet, film coated, oral | 69097-426ANDA |
| ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | granule, for suspension, extended release, oral | 69097-527ANDA |
| EXEMESTANE | exemestane | tablet, oral | 69097-316ANDA |
| - | Efavirenz | powder | 53104-7544BULK INGREDIENT |
| Efavirenz | Efavirenz | tablet, film coated, oral | 69097-301ANDA |
| - | Empagliflozin | powder | 53104-7723BULK INGREDIENT |
| - | Emtricitabine | powder | 53104-7637BULK INGREDIENT |
| - | Entecavir | powder | 53104-7692BULK INGREDIENT |
| - | Enzalutamide | powder | 53104-7745BULK INGREDIENT |
| - | Erlotinib Hydrochloride | powder | 53104-7716BULK INGREDIENT |
| - | Escitalopram Oxalate | powder | 53104-7565BULK INGREDIENT |
| Escitalopram Oxalate | Escitalopram | tablet, film coated, oral | 69097-847ANDA |
| Escitalopram Oxalate | Escitalopram | tablet, film coated, oral | 69097-848ANDA |
| Escitalopram Oxalate | Escitalopram | tablet, film coated, oral | 69097-849ANDA |
| - | Esomeprazole Magnesium | powder | 53104-7554BULK INGREDIENT |
| - | Esomeprazole Magnesium Dihydrate | powder | 53104-7608BULK INGREDIENT |
| Esomeprazole magnesium | Esomeprazole magnesium | for suspension, oral | 69097-507ANDA |
| Esomeprazole magnesium | Esomeprazole magnesium | for suspension, oral | 69097-508ANDA |
| Esomeprazole magnesium | Esomeprazole magnesium | for suspension, oral | 69097-528ANDA |
| Esomeprazole magnesium | Esomeprazole magnesium | for suspension, oral | 69097-529ANDA |
| - | Etoposide | powder | 53104-7514BULK INGREDIENT |
| - | Exemestane | powder | 53104-7666BULK INGREDIENT |
| - | FINASTERIDE | powder | 53104-7714BULK INGREDIENT |
| - | FLUTICASONE PROPIONATE | powder | 53104-7531BULK INGREDIENT |
| FOSFOMYCIN TROMETHAMINE | FOSFOMYCIN TROMETHAMINE | granule, for solution, oral | 69097-579ANDA |
| - | Famciclovir | powder | 53104-7616BULK INGREDIENT |
| - | Felodipine | powder | 53104-7519BULK INGREDIENT |
| Fenofibrate | FENOFIBRATE | tablet, oral | 69097-458ANDA |
| Fenofibrate | FENOFIBRATE | tablet, oral | 69097-459ANDA |
| Fenofibrate | fenofibrate | capsule, oral | 69097-894ANDA |
| Fenofibrate | fenofibrate | capsule, oral | 69097-895ANDA |
| Fenofibrate | fenofibrate | capsule, oral | 69097-896ANDA |
| - | Fluconazole | powder | 53104-7569BULK INGREDIENT |
| - | Flutamide | powder | 53104-7536BULK INGREDIENT |
| Fluticasone propionate and Salmeterol | Fluticasone propionate and Salmeterol | powder, respiratory (inhalation) | 69097-661ANDA |
| Fluticasone propionate and Salmeterol | Fluticasone propionate and Salmeterol | powder, respiratory (inhalation) | 69097-662ANDA |
| Fluticasone propionate and Salmeterol | Fluticasone propionate and Salmeterol | powder, respiratory (inhalation) | 69097-663ANDA |
| - | Formoterol Fumarate | powder | 53104-7530BULK INGREDIENT |
| Fosinopril Sodium | Fosinopril | tablet, oral | 69097-856ANDA |
| Fosinopril Sodium | Fosinopril | tablet, oral | 69097-857ANDA |
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
- Lupin LimitedPune, IND; Salcette, IND · 2 sites
- SHILPA MEDICARE LIMITEDBengaluru, IND · 2 sites
- Emcure Pharmaceuticals LimitedPune, IND · 2 sites
- Anthem Biosciences LimitedBengaluru, IND · 2 sites
- ONESOURCE SPECIALTY PHARMA LIMITEDBengaluru, IND · 2 sites
- Eurofins Advinus BioPharma Services India Private LimitedBENGALURU, IND; Bengaluru, IND · 2 sites
- Viatris Inc.Bengaluru, IND
- Viyash Scientific LimitedRaigad, IND
- Indoco Remedies LimitedRaigad, IND
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Enquiry
Common questions
- Is CIPLA PHARMACEUTICALS LIMITED FDA approved?
- CIPLA 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 CIPLA PHARMACEUTICALS LIMITED's drugs manufactured?
- The FDA register lists Bengaluru; Indore; Pune; Raigad; Salcette. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging.
- What drugs does CIPLA PHARMACEUTICALS LIMITED make?
- 368 products are listed under CIPLA PHARMACEUTICALS LIMITED in the openFDA NDC Directory, most often as powder; tablet; capsule. The full breakdown by dosage form and route is above. A listing count is not a sales figure.
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.