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Hetero Labs Limited

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Registered sites
8
Active NDC listings
167
Labeller names
3
Live patents
0
Countries
1
Base
India
Authorisation

Registered operations

Active ingredient (API) manufacture2Finished drug manufacture6
Sites

Registered establishments

8
EstablishmentAddressRegistered forFEI / DUNS
Hetero Labs LimitedUnit IX, Plot No. 2, Hetero Infrastructure SEZ Ltd., N. Narasapuram Village, Nakkapalli (Mandal), Anakapalli District, Andhra Pradesh 531081, India (IND)Active ingredient (API) manufacture3009093782650563526
Hetero Labs LimitedUnit III, Survey No.120, 128, 150(Part), 150/1,151/2 &158/1, N. Narasapuram, Nallamattipalem, Nakkapalli (Mandal), Anakapalli District, Andhra Pradesh 531081, India (IND)Finished drug manufacture3011002833915838368
HETERO HEALTHCARE LIMITEDHetero Healthcare Ltd, Aiidc Growth Centre, Niz Sila Sinduri Ghopa, Chansari Kamrup, Guwahati, Assam 781101, India (IND)Finished drug manufacture3013890701877221774
Hetero Labs LimitedPlot No. 28P1 to 36P1 and 37 to 54, Vemagal Industrial Area, Hobli Vemagal Kolar, Karnataka 563102, India (IND)Finished drug manufacture3022837118738673104
Hetero Labs LimitedUnit III, Plot No. 22-110, Part-II, IDA, Jeedimetla, Hyderabad, Telangana 500055, India (IND)Finished drug manufacture3005406526676162024
Hetero Labs LimitedUnit VI, Sy. No.: 410 & 411, TSIIC Formulation SEZ, Polepally Village, Jadcherla Mandal,, Mahabubnagar, Telangana 509301, India (IND)Finished drug manufacture3008294355650452548
Hetero Labs LimitedUnit V, Sy. No.: 439, 440, 441 & 458, TSIIC Formulation SEZ, Polepally Village, Mahabubnagar, Telangana 509301, India (IND)Finished drug manufacture3008307735650452530
Hetero Labs LimitedUnit-I, Survey No. 10, I.D.A., Gaddapotharam (Village), Jinnaram (Mandal), Sangareddy, Telangana 502319, India (IND)Active ingredient (API) manufacture3004378446650435873
Catalogue

Drug listings by form and route

167

167 active NDC listings: 164 bulk ingredient, 2 human prescription drug, 1 human otc drug. By marketing category: BULK INGREDIENT 164, ANDA 2, OTC MONOGRAPH DRUG 1.

Dosage formNDCs
powder164
tablet, film coated2
patch1
RouteNDCs
oral2
topical1
Labeller name on the listingNDCs
hetero labs limited114
hetero labs limited52
hetero healthcare limited1
Catalogue

Marketed products

167

Showing 150 of 167.

BrandGeneric nameForm / routeNDC
-Abacavir Sulfatepowder68554-0032BULK INGREDIENT
-Abacavir Sulfatepowder68554-0063BULK INGREDIENT
-Abemaciclibpowder68554-0173BULK INGREDIENT
-Abiraterone Acetatepowder68554-0082BULK INGREDIENT
-Acyclovirpowder68554-0159BULK INGREDIENT
-Afatinib Dimaleatepowder68554-0107BULK INGREDIENT
-Alectinib Hydrochloridepowder68554-0150BULK INGREDIENT
-Anastrozolepowder68554-0026BULK INGREDIENT
-Apalutamidepowder68554-0127BULK INGREDIENT
-Apalutamide Premixpowder68554-0169BULK INGREDIENT
-Aripiprazolepowder68554-0020BULK INGREDIENT
-Asciminib Hydrochloride Premixpowder68554-0181BULK INGREDIENT
-Atazanavir Sulfatepowder68554-0055BULK INGREDIENT
-Atazanavir Sulfatepowder68554-0101BULK INGREDIENT
-Atomoxetine Hydrochloridepowder68554-0021BULK INGREDIENT
-Atomoxetine Hydrochloridepowder68554-0149BULK INGREDIENT
-Atorvastatin Calcium Trihydratepowder68554-0096BULK INGREDIENT
-Avacopanpowder68554-0175BULK INGREDIENT
-Azacitidinepowder68554-0104BULK INGREDIENT
-BICTEGRAVIR SODIUMpowder68554-0122BULK INGREDIENT
-Belumosudil Mesylatepowder68554-0172BULK INGREDIENT
-Belzutifan Premixpowder68554-0179BULK INGREDIENT
-Bendamustinepowder68554-0050BULK INGREDIENT
-Berotralstat Dihydrochloridepowder68554-0167BULK INGREDIENT
-Bexarotenepowder68554-0081BULK INGREDIENT
-Bicalutamide (Form-H1)powder68554-0001BULK INGREDIENT
-Bortezomibpowder68554-0051BULK INGREDIENT
-Bosutinibpowder68554-0161BULK INGREDIENT
-Cabazitaxelpowder68554-0080BULK INGREDIENT
-Capecitabinepowder68554-0033BULK INGREDIENT
-Carboplatinpowder68554-0084BULK INGREDIENT
-Carfilzomibpowder68554-0163BULK INGREDIENT
-Cisplatinpowder68554-0077BULK INGREDIENT
-Crizotinibpowder68554-0170BULK INGREDIENT
-Cyclophosphamidepowder68554-0062BULK INGREDIENT
-DORAVIRINEpowder68554-0132BULK INGREDIENT
-Daclatasvir Dihydrochloridepowder68554-0094BULK INGREDIENT
-Darolutamide Premixpowder68554-0140BULK INGREDIENT
-Darunavirpowder68554-0035BULK INGREDIENT
-Darunavirpowder68554-0114BULK INGREDIENT
-Dasatinibpowder68554-0070BULK INGREDIENT
-Dasatinibpowder68554-0177BULK INGREDIENT
-Diltiazem Hydrochloridepowder68554-0157BULK INGREDIENT
-Dolutegravirpowder68554-0135BULK INGREDIENT
-Dolutegravir Sodiumpowder68554-0093BULK INGREDIENT
-Doravirinepowder68554-0133BULK INGREDIENT
-Dutasteridepowder68554-0079BULK INGREDIENT
-Efavirenzpowder68554-0018BULK INGREDIENT
-Efavirenzpowder68554-0042BULK INGREDIENT
-Elagolix Sodiumpowder68554-0131BULK INGREDIENT
-Elagolix Sodiumpowder68554-0155BULK INGREDIENT
-Emtricitabinepowder68554-0027BULK INGREDIENT
-Emtricitabinepowder68554-0064BULK INGREDIENT
-Entacaponepowder68554-0068BULK INGREDIENT
-Enzalutamidepowder68554-0106BULK INGREDIENT
-Eplerenonepowder68554-0116BULK INGREDIENT
-Erlotinibpowder68554-0052BULK INGREDIENT
-Escitalopram Oxalatepowder68554-0007BULK INGREDIENT
-Escitalopram Oxalatepowder68554-0136BULK INGREDIENT
-Escitalopram Oxalatepowder68554-0147BULK INGREDIENT
-Etoricoxibpowder68554-0053BULK INGREDIENT
-Etravirinepowder68554-0056BULK INGREDIENT
-Etravirinepowder68554-0137BULK INGREDIENT
-Etravirine Premixpowder68554-0125BULK INGREDIENT
-Ezetimibepowder68554-0085BULK INGREDIENT
-Ezetimibepowder68554-0152BULK INGREDIENT
-Ezetimibe (Form-B)powder68554-0180BULK INGREDIENT
-Finasteridepowder68554-0022BULK INGREDIENT
-Fostamatinib Disodium Hexahydratepowder68554-0130BULK INGREDIENT
-Fostamatinib Disodium Hexahydratepowder68554-0154BULK INGREDIENT
-Gabapentinpowder68554-0128BULK INGREDIENT
-Gefitinibpowder68554-0060BULK INGREDIENT
-Gemcitabine Hydrochloridepowder68554-0028BULK INGREDIENT
-Hydralazine Hydrochloridepowder68554-0023BULK INGREDIENT
-Hydralazine Hydrochloridepowder68554-0148BULK INGREDIENT
-Hydroxy Chloroquine Sulfatepowder68554-0146BULK INGREDIENT
-Ibrutinibpowder68554-0109BULK INGREDIENT
-Imatinibpowder68554-0034BULK INGREDIENT
-Irbesartanpowder68554-0005BULK INGREDIENT
-Irinotecanpowder68554-0054BULK INGREDIENT
-Ivacaftorpowder68554-0168BULK INGREDIENT
-Lamivudinepowder68554-0016BULK INGREDIENT
-Lamivudinepowder68554-0043BULK INGREDIENT
-Lapatinib Ditosylatepowder68554-0072BULK INGREDIENT
-Lenacapavirpowder68554-0182BULK INGREDIENT
-Lenacapavir Spray-Dried Dispersionpowder68554-0176BULK INGREDIENT
-Lenalidomidepowder68554-0090BULK INGREDIENT
-Lenvatinibpowder68554-0160BULK INGREDIENT
-Letrozolepowder68554-0039BULK INGREDIENT
-Levetiracetampowder68554-0065BULK INGREDIENT
-Levetiracetam (Form-I)powder68554-0006BULK INGREDIENT
-Levomilnacipranpowder68554-0115BULK INGREDIENT
Lidfix Pain Relief Patch LidocaineLIDOCAINEpatch, topical87497-001OTC MONOGRAPH DRUG
-Lidocaine Hydrochloridepowder68554-0153BULK INGREDIENT
-Lopinavirpowder68554-0019BULK INGREDIENT
-Lopinavirpowder68554-0138BULK INGREDIENT
-Losartan Potassiumpowder68554-0008BULK INGREDIENT
-Maravirocpowder68554-0040BULK INGREDIENT
-Maravirocpowder68554-0158BULK INGREDIENT
MaravirocMaraviroctablet, film coated, oral68554-3079ANDA
MaravirocMaraviroctablet, film coated, oral68554-3080ANDA
-Melphalan Hydrochloridepowder68554-0087BULK INGREDIENT
-Midostaurinpowder68554-0126BULK INGREDIENT
-Milnacipran Hydrochloridepowder68554-0066BULK INGREDIENT
-Naproxenpowder68554-0143BULK INGREDIENT
-Naproxen Sodiumpowder68554-0129BULK INGREDIENT
-Nevirapinepowder68554-0044BULK INGREDIENT
-Nevirapine Anhydrouspowder68554-0014BULK INGREDIENT
-Nilotinib Hydrochloride Dihydratepowder68554-0059BULK INGREDIENT
-Nintedanib esylatepowder68554-0123BULK INGREDIENT
-OBETICHOLIC ACIDpowder68554-0121BULK INGREDIENT
-Olaparibpowder68554-0120BULK INGREDIENT
-Olmesartan Medoxomilpowder68554-0069BULK INGREDIENT
-Opicaponepowder68554-0174BULK INGREDIENT
-Oseltamivir Phosphatepowder68554-0029BULK INGREDIENT
-Oxaliplatinpowder68554-0083BULK INGREDIENT
-PEMETREXED DISODIUM HEMIPENTAHYDRATEpowder68554-0074BULK INGREDIENT
-Paclitaxelpowder68554-0061BULK INGREDIENT
-Palbociclibpowder68554-0112BULK INGREDIENT
-Pazopanib Hydrochloridepowder68554-0058BULK INGREDIENT
-Pioglitazone Hydrochloridepowder68554-0030BULK INGREDIENT
-Pioglitazone Hydrochloridepowder68554-0156BULK INGREDIENT
-Pirtobrutinibpowder68554-0189BULK INGREDIENT
-Plerixaforpowder68554-0067BULK INGREDIENT
-Pomalidomidepowder68554-0091BULK INGREDIENT
-Ponatinib Hydrochloridepowder68554-0186BULK INGREDIENT
-Pralatrexatepowder68554-0071BULK INGREDIENT
-Pregabalinpowder68554-0145BULK INGREDIENT
-Quetiapine Fumaratepowder68554-0024BULK INGREDIENT
-Quetiapine Fumaratepowder68554-0089BULK INGREDIENT
-RIMEGEPANT HEMISULFATE SESQUIHYDRATEpowder68554-0184BULK INGREDIENT
-Ramiprilpowder68554-0004BULK INGREDIENT
-Relugolix (Form-I)powder68554-0165BULK INGREDIENT
-Ritonavirpowder68554-0117BULK INGREDIENT
-Saquinavirpowder68554-0036BULK INGREDIENT
-Simvastatinpowder68554-0010BULK INGREDIENT
-Sofosbuvirpowder68554-0139BULK INGREDIENT
-Sorafenibpowder68554-0073BULK INGREDIENT
-Sotorasibpowder68554-0171BULK INGREDIENT
-Sunitinib Malatepowder68554-0078BULK INGREDIENT
-Temozolomidepowder68554-0048BULK INGREDIENT
-Tenofovir Alafenamide Hemifumaratepowder68554-0105BULK INGREDIENT
-Tenofovir Alafenamide Hemifumaratepowder68554-0144BULK INGREDIENT
-Tenofovir Disoproxilpowder68554-0046BULK INGREDIENT
-Tenofovir Disoproxil Fumaratepowder68554-0031BULK INGREDIENT
-Terbinafine Hydrochloridepowder68554-0002BULK INGREDIENT
-Thalidomidepowder68554-0011BULK INGREDIENT
-Tipiracil Hydrochloridepowder68554-0119BULK INGREDIENT
-Tolvaptan Povidone Premixpowder68554-0142BULK INGREDIENT
-Torsemidepowder68554-0025BULK INGREDIENT
Neighbours

Registered in the same town

12
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Enquiry

Common questions

Is Hetero Labs Limited FDA approved?
Hetero Labs Limited holds 8 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 Hetero Labs Limited's drugs manufactured?
The FDA register lists Anakapalli District; Guwahati; Hobli Vemagal Kolar; Hyderabad; Mahabubnagar; Sangareddy. Registered operations: active ingredient (API) manufacture, finished drug manufacture.
What drugs does Hetero Labs Limited make?
167 products are listed under Hetero Labs Limited in the openFDA NDC Directory, most often as powder; tablet, film coated; patch. 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.