Register entry
- Registered sites
- 5
- Active NDC listings
- 87
- Labeller names
- 2
- Live patents
- 0
- Countries
- 1
- Base
- India
Authorisation
Registered operations
Analytical testing5Active ingredient (API) manufacture5Finished drug manufacture1
Sites
Registered establishments
5| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| LAURUS LABS LIMITED | Plot No. 21, Jawaharlal Nehru Pharma City, Parawada, Anakapalli, Andhra Pradesh 531021, India (IND) | Analytical testing, Active ingredient (API) manufacture | 3007083664915075687 |
| LAURUS LABS LIMITED | Plot No. 19, 20 & 21, Western Sector APSEZ Gurajapalem Village, Rambilli Mandal, Anakapalli, Andhra Pradesh 531011, India (IND) | Analytical testing, Active ingredient (API) manufacture, Finished drug manufacture | 3011538548650885309 |
| LAURUS LABS LIMITED | Plot No. 25, 25A to 25K, APSEZ De-Notified Area, Lalamkoduru Village, Rambilli Mandal, Anakapalli, Andhra Pradesh 531011, India (IND) | Analytical testing, Active ingredient (API) manufacture | 3014255847675474102 |
| LAURUS LABS LIMITED | Plot No. 102 & 103, Visakha Pharmacity Limited SEZ, Parawada, Anakapalli, Andhra Pradesh 531 019, India (IND) | Analytical testing, Active ingredient (API) manufacture | 3017037090651018702 |
| LAURUS LABS LIMITED | Plot No. DS-1 & 2, IKP Knowledge Park, Genome Valley, Turkapally Village, Shamirpet Mandal, Medchal-Malkajgiri, Telangana 500101, India (IND) | Analytical testing, Active ingredient (API) manufacture | 3006527015676413153 |
Catalogue
Drug listings by form and route
8787 active NDC listings: 53 human prescription drug, 33 bulk ingredient, 1 drug for further processing. By marketing category: ANDA 53, BULK INGREDIENT 33, DRUG FOR FURTHER PROCESSING 1.
| Dosage form | NDCs |
|---|---|
| tablet, film coated | 33 |
| powder | 31 |
| capsule | 13 |
| tablet | 4 |
| capsule, delayed release | 2 |
| tablet, extended release | 2 |
| granule | 1 |
| liquid | 1 |
| Route | NDCs |
|---|---|
| oral | 53 |
| Labeller name on the listing | NDCs |
|---|---|
| laurus labs limited | 68 |
| laurus labs limited | 19 |
Catalogue
Marketed products
87| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| - | AZACITIDINE | powder | 42385-312BULK INGREDIENT |
| - | AZACITIDINE | powder | 42385-719BULK INGREDIENT |
| Abacavir and Lamivudine | Abacavir and Lamivudine | tablet, film coated, oral | 42385-962ANDA |
| - | Apalutamide | powder | 42385-314BULK INGREDIENT |
| Atazanavir | Atazanavir | capsule, oral | 42385-920ANDA |
| Atazanavir | Atazanavir | capsule, oral | 42385-921ANDA |
| Atazanavir | Atazanavir | capsule, oral | 42385-922ANDA |
| Atorvastatin Calcium | Atorvastatin Calcium | tablet, film coated, oral | 42385-940ANDA |
| Atorvastatin Calcium | Atorvastatin Calcium | tablet, film coated, oral | 42385-941ANDA |
| Atorvastatin Calcium | Atorvastatin Calcium | tablet, film coated, oral | 42385-942ANDA |
| Atorvastatin Calcium | Atorvastatin Calcium | tablet, film coated, oral | 42385-943ANDA |
| - | Atropine Sulfate | powder | 42385-736BULK INGREDIENT |
| - | BRIMONIDINE TARTRATE | powder | 42385-038BULK INGREDIENT |
| - | BRIMONIDINE TARTRATE | powder | 42385-750BULK INGREDIENT |
| - | Bimatoprost | powder | 42385-030BULK INGREDIENT |
| - | Bortezomib | powder | 42385-716BULK INGREDIENT |
| - | CANAGLIFLOZIN | powder | 42385-735BULK INGREDIENT |
| - | CARFILZOMIB | powder | 42385-731BULK INGREDIENT |
| - | Cyclopentolate Hydrochloride | powder | 42385-105BULK INGREDIENT |
| - | DARUNAVIR | powder | 42385-728BULK INGREDIENT |
| - | Digoxin | powder | 42385-101BULK INGREDIENT |
| - | ENZALUTAMIDE | powder | 42385-733BULK INGREDIENT |
| Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate | Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate | tablet, film coated, oral | 42385-928ANDA |
| Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate | Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate | tablet, film coated, oral | 42385-929ANDA |
| Efavirenz, emtricitabine and tenofovir disoproxil fumarate | Efavirenz, emtricitabine and tenofovir disoproxil fumarate | tablet, film coated, oral | 42385-915ANDA |
| - | Emtricitabine | powder | 42385-304BULK INGREDIENT |
| Emtricitabine and Tenofovir Disoproxil Fumarate | Emtricitabine and Tenofovir Disoproxil Fumarate | tablet, film coated, oral | 42385-953ANDA |
| - | FELBAMATE | powder | 42385-721BULK INGREDIENT |
| FENOFIBRATE | FENOFIBRATE | tablet, film coated, oral | 42385-935ANDA |
| FENOFIBRATE | FENOFIBRATE | tablet, film coated, oral | 42385-936ANDA |
| FENOFIBRIC ACID DELAYED-RELEASE | FENOFIBRIC ACID | capsule, delayed release, oral | 42385-944ANDA |
| FENOFIBRIC ACID DELAYED-RELEASE | Fenofibric Acid | capsule, delayed release, oral | 42385-945ANDA |
| Flucytosine | Flucytosine | capsule, oral | 42385-983ANDA |
| Flucytosine | Flucytosine | capsule, oral | 42385-984ANDA |
| Gabapentin | Gabapentin | capsule, oral | 42385-972ANDA |
| Gabapentin | Gabapentin | capsule, oral | 42385-973ANDA |
| Gabapentin | Gabapentin | capsule, oral | 42385-974ANDA |
| Gabapentin | Gabapentin | tablet, film coated, oral | 42385-979ANDA |
| Gabapentin | Gabapentin | tablet, film coated, oral | 42385-980ANDA |
| - | Gemcitabine Hydrochloride | powder | 42385-748BULK INGREDIENT |
| HYDROXYCHLOROQUINE SULFATE | HYDROXYCHLOROQUINE SULFATE | tablet, film coated, oral | 42385-971ANDA |
| - | Homatropine Hydrobromide | powder | 42385-749BULK INGREDIENT |
| - | Homatropine Methylbromide | powder | 42385-737BULK INGREDIENT |
| - | IMATINIB MESYLATE | powder | 42385-720BULK INGREDIENT |
| - | Imatinib Mesylate | powder | 42385-316BULK INGREDIENT |
| - | Irinotecan Hydrochloride Trihydrate | powder | 42385-711BULK INGREDIENT |
| - | LATANOPROST | liquid | 42385-039BULK INGREDIENT |
| - | Lamivudine | powder | 42385-714BULK INGREDIENT |
| Lopinavir and Ritonavir | Lopinavir and Ritonavir | tablet, film coated, oral | 42385-933ANDA |
| Lopinavir and Ritonavir | Lopinavir and Ritonavir | tablet, film coated, oral | 42385-934ANDA |
| - | METFORMIN HYDROCHLORIDE | powder | 42385-501BULK INGREDIENT |
| - | METFORMIN HYDROCHLORIDE | granule | 42385-502BULK INGREDIENT |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | tablet, extended release, oral | 42385-977ANDA |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | tablet, extended release, oral | 42385-978ANDA |
| Macitentan | Macitentan | tablet, film coated, oral | 42385-907ANDA |
| Metformin Hydrochloride | Metformin Hydrochloride | tablet, film coated, oral | 42385-947ANDA |
| Metformin Hydrochloride | Metformin Hydrochloride | tablet, film coated, oral | 42385-948ANDA |
| Metformin Hydrochloride | Metformin Hydrochloride | tablet, film coated, oral | 42385-949ANDA |
| - | Montelukast Sodium | powder | 42385-709BULK INGREDIENT |
| Oseltamivir | Oseltamivir phosphate | capsule, oral | 42385-985ANDA |
| Oseltamivir | Oseltamivir phosphate | capsule, oral | 42385-986ANDA |
| Oseltamivir | Oseltamivir phosphate | capsule, oral | 42385-987ANDA |
| - | PREGABALIN | powder | 42385-308BULK INGREDIENT |
| - | Pirfenidone | powder | 42385-305BULK INGREDIENT |
| Pirfenidone | Pirfenidone | capsule, oral | 42385-923ANDA |
| Pirfenidone | Pirfenidone | tablet, film coated, oral | 42385-924ANDA |
| Pirfenidone | Pirfenidone | tablet, film coated, oral | 42385-925ANDA |
| Pirfenidone | Pirfenidone | tablet, film coated, oral | 42385-926ANDA |
| Rilpivirine | Rilpivirine | tablet, film coated, oral | 42385-999ANDA |
| Sacubitril and Valsartan | Sacubitril and Valsartan | tablet, film coated, oral | 42385-930ANDA |
| Sacubitril and Valsartan | Sacubitril and Valsartan | tablet, film coated, oral | 42385-931ANDA |
| Sacubitril and Valsartan | Sacubitril and Valsartan | tablet, film coated, oral | 42385-932ANDA |
| - | Suzetrigine | tablet, film coated | 42385-617DRUG FOR FURTHER PROCESSING |
| - | TENOFOVIR DISOPROXIL FUMARATE | powder | 42385-741BULK INGREDIENT |
| - | Tenofovir Disoproxil Fumarate | powder | 42385-318BULK INGREDIENT |
| - | Tenofovir Disoproxil Fumarate | powder | 42385-707BULK INGREDIENT |
| Ticagrelor | Ticagrelor | tablet, oral | 42385-993ANDA |
| Ticagrelor | Ticagrelor | tablet, oral | 42385-994ANDA |
| - | Tropicamide | powder | 42385-114BULK INGREDIENT |
| Ursodiol | Ursodiol | capsule, oral | 42385-946ANDA |
| Valsartan | Valsartan | tablet, film coated, oral | 42385-989ANDA |
| Valsartan | Valsartan | tablet, film coated, oral | 42385-990ANDA |
| Valsartan | Valsartan | tablet, film coated, oral | 42385-991ANDA |
| Valsartan | Valsartan | tablet, film coated, oral | 42385-992ANDA |
| emtricitabine, rilpivirine and tenofovir disoproxil fumarate | emtricitabine, rilpivirine and tenofovir disoproxil fumarate | tablet, film coated, oral | 42385-801ANDA |
| fenofibrate | fenofibrate | tablet, oral | 42385-950ANDA |
| fenofibrate | fenofibrate | tablet, oral | 42385-951ANDA |
Neighbours
Registered in the same town
12- Dr. Reddy's Laboratories LimitedMedchal-Malkajgiri, IND · 3 sites
- Biocon Biologics LimitedAnakapalli, IND · 2 sites
- Viyash Scientific LimitedAnakapalli, IND; Medchal-Malkajgiri, IND · 2 sites
- Granules Pharmaceuticals Inc.Anakapalli, IND · 2 sites
- Cohance Lifesciences LimitedMedchal-Malkajgiri, IND · 2 sites
- EUGIA Pharma Specialities LimitedAnakapalli, IND; Medchal-Malkajgiri, IND · 2 sites
- BE BIOSOL PRIVATE LIMITEDMedchal-Malkajgiri, IND · 2 sites
- LAURUS SYNTHESIS PRIVATE LIMITEDAnakapalli, IND · 2 sites
- Apitoria Pharma Private LimitedAnakapalli, IND
- Hospira, Inc.Anakapalli, IND
- NATCO PHARMA LIMITEDAnakapalli, IND
- Ajinomoto OmniChem N.V.Anakapalli, IND
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- Torrent Pharma, Inc.5 sites · 184 NDC
- Micro Labs Limited5 sites · 141 NDC
- Matrix Pharmacorp Private Limited5 sites · 122 NDC
- NATCO PHARMA LIMITED5 sites · 108 NDC
- Encube Ethicals Limited5 sites · 77 NDC
- SHILPA MEDICARE LIMITED5 sites · 4 NDC
Enquiry
Common questions
- Is LAURUS LABS LIMITED FDA approved?
- LAURUS LABS LIMITED holds 5 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 LAURUS LABS LIMITED's drugs manufactured?
- The FDA register lists Anakapalli; Medchal-Malkajgiri. Registered operations: analytical testing, active ingredient (API) manufacture, finished drug manufacture.
- What drugs does LAURUS LABS LIMITED make?
- 87 products are listed under LAURUS LABS LIMITED in the openFDA NDC Directory, most often as tablet, film coated; powder; 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.