Register entry
- Registered sites
- 4
- Active NDC listings
- 64
- Labeller names
- 6
- Live patents
- 0
- Countries
- 2
- Base
- India
Authorisation
Registered operations
Analytical testing3Active ingredient (API) manufacture4Relabelling1Repackaging1sterilize1
Sites
Registered establishments
4| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| APICORE PHARMACEUTICALS PRIVATE LIMITED | Plot No: 80D, Road No. 20, Jawaharlal Nehru Pharmacity, Parawada., Anakapalli, Andhra pradesh 531021, India (IND) | Active ingredient (API) manufacture | 3012575874872255143 |
| APICORE PHARMACEUTICALS PRIVATE LIMITED | Plot No. 154/A/6, Survey number 172/A, S V Co-operative Industrial Estate, IDA Bollaram, Bollaram Village, Jinnaram Mandal, Sangareddy., Hyderabad, Telangana 502325, India (IND) | Analytical testing, Active ingredient (API) manufacture | 3007136165677520290 |
| APICORE PHARMACEUTICALS PRIVATE LIMITED | Block No. 252-253, Village - Dhobikuva, Opposite Jain Irrigation, Padra - Jambusar Highway, Tal. Padra., Vadodara, Gujarat 391440, India (IND) | Analytical testing, Active ingredient (API) manufacture, Relabelling, Repackaging, sterilize | 3006767695676248879 |
| Apicore US LLC | 148 Princeton Hightstown Rd, Suite 300, East Windsor Township, New Jersey (NJ) 08520, United States (USA) | Analytical testing, Active ingredient (API) manufacture | 3004864046079469682 |
Catalogue
Drug listings by form and route
6464 active NDC listings: 64 bulk ingredient. By marketing category: BULK INGREDIENT 62, BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING 2.
| Dosage form | NDCs |
|---|---|
| powder | 61 |
| injection, powder, for solution | 1 |
| injection, powder, lyophilized, for solution | 1 |
| injection, solution | 1 |
| Route | NDCs |
|---|
| Labeller name on the listing | NDCs |
|---|---|
| apicore pharmaceuticals private limited | 41 |
| apicore pharmaceuticals private limited | 14 |
| apicore pharmaceuticals private limited | 5 |
| apicore pharmaceuticals private limited | 2 |
| apicore pharmaceuticals private limited | 1 |
| apicore pharmaceuticals pvt. ltd. | 1 |
Catalogue
Marketed products
64| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| - | ALCAFTADINE | powder | 42973-204BULK INGREDIENT |
| - | AZATHIOPRINE | powder | 42973-143BULK INGREDIENT |
| - | BORTEZOMIB | powder | 42973-140BULK INGREDIENT |
| - | BROMFENAC SODIUM | powder | 42973-144BULK INGREDIENT |
| - | Betamethasone Acetate | powder | 42973-416BULK INGREDIENT |
| - | Bexarotene | powder | 42973-420BULK INGREDIENT |
| - | Busulfan | powder | 42973-392BULK INGREDIENT |
| - | CETRORELIX ACETATE | powder | 42973-326BULK INGREDIENT |
| - | CEVIMELINE HYDROCHLORIDE | powder | 42973-228BULK INGREDIENT |
| - | CLOFARABINE | powder | 42973-173BULK INGREDIENT |
| - | COLESTIPOL HYDROCHLORIDE | powder | 42973-176BULK INGREDIENT |
| - | COLESTIPOL HYDROCHLORIDE-POVIDONE PREMIX | powder | 42973-245BULK INGREDIENT |
| - | CYCLOPHOSPHAMIDE | powder | 42973-318BULK INGREDIENT |
| - | Carfilzomib | powder | 42973-205BULK INGREDIENT |
| - | Cevimeline Hydrochloride | injection, solution | 42973-395BULK INGREDIENT |
| - | DACARBAZINE | powder | 42973-149BULK INGREDIENT |
| - | DEGARELIX ACETATE MANNITOL | powder | 42973-343BULK INGREDIENT |
| - | DEGARELIX ACETATE MANNITOL | powder | 42973-344BULK INGREDIENT |
| - | DIFLUNISAL | powder | 42973-152BULK INGREDIENT |
| - | DISULFIRAM | powder | 42973-137BULK INGREDIENT |
| - | DROXIDOPA | powder | 42973-237BULK INGREDIENT |
| - | Degarelix Acetate | powder | 42973-321BULK INGREDIENT |
| - | ETHACRYNIC ACID | powder | 42973-169BULK INGREDIENT |
| - | FERRIC CARBOXYMALTOSE | powder | 42973-330BULK INGREDIENT |
| - | FERUMOXYTOL | powder | 42973-331BULK INGREDIENT |
| - | FLUCYTOSINE | powder | 42973-193BULK INGREDIENT |
| - | Ferric Citrate | powder | 42973-374BULK INGREDIENT |
| - | Ferric Derisomaltose | powder | 42973-385BULK INGREDIENT |
| - | Ferric Maltol | powder | 42973-352BULK INGREDIENT |
| - | Ferric carboxymaltose | powder | 42973-434BULK INGREDIENT |
| - | GANIRELIX ACETATE | powder | 42973-325BULK INGREDIENT |
| - | Lurbinectedin | injection, powder, lyophilized, for solution | 42973-353BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING |
| - | MAFENIDE ACETATE | powder | 42973-157BULK INGREDIENT |
| - | MARALIXIBAT CHLORIDE | powder | 42973-381BULK INGREDIENT |
| - | MIGLUSTAT | powder | 42973-166BULK INGREDIENT |
| - | MOLINDONE HYDROCHLORIDE | powder | 42973-126BULK INGREDIENT |
| - | NADOLOL | powder | 42973-148BULK INGREDIENT |
| - | NETUPITANT | powder | 42973-212BULK INGREDIENT |
| - | PENICILLAMINE | powder | 42973-230BULK INGREDIENT |
| - | PERPHENAZINE | powder | 42973-165BULK INGREDIENT |
| - | PHENTOLAMINE MESYLATE | powder | 42973-194BULK INGREDIENT |
| - | PLERIXAFOR | powder | 42973-202BULK INGREDIENT |
| - | POMALIDOMIDE | powder | 42973-232BULK INGREDIENT |
| - | PONATINIB HYDROCHLORIDE | powder | 42973-242BULK INGREDIENT |
| - | PRIMAQUINE PHOSPHATE | powder | 42973-177BULK INGREDIENT |
| - | Phentolamine Mesylate | injection, powder, for solution | 42973-389BULK INGREDIENT |
| - | Phentolamine Mesylate | powder | 42973-423BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING |
| - | REGADENOSON | powder | 42973-229BULK INGREDIENT |
| - | SAFINAMIDE MESYLATE | powder | 42973-301BULK INGREDIENT |
| - | SELEGILINE | powder | 42973-408BULK INGREDIENT |
| - | SELEXIPAG-MANNITOL PREMIX | powder | 42973-307BULK INGREDIENT |
| - | SINCALIDE | powder | 42973-235BULK INGREDIENT |
| - | SODIUM NITROPRUSSIDE | powder | 42973-231BULK INGREDIENT |
| - | SUGAMMADEX SODIUM | powder | 42973-233BULK INGREDIENT |
| - | Semaglutide | powder | 42973-397BULK INGREDIENT |
| - | Setmelanotide acetate | powder | 42973-415BULK INGREDIENT |
| - | Sugammadex sodium | powder | 42973-394BULK INGREDIENT |
| - | TETRABENAZINE | powder | 42973-179BULK INGREDIENT |
| - | Tirzepatide | powder | 42973-383BULK INGREDIENT |
| - | VORTIOXETINE HYDROBROMIDE | powder | 42973-236BULK INGREDIENT |
| - | VOSORITIDE | powder | 42973-398BULK INGREDIENT |
| - | ZILEUTON | powder | 42973-156BULK INGREDIENT |
| - | belzutifan | powder | 42973-376BULK INGREDIENT |
| - | pentosan polysulfate sodim | powder | 42973-367BULK INGREDIENT |
Neighbours
Registered in the same town
12- Alembic Pharmaceuticals LimitedVADODARA, IND; Vadodara, IND · 4 sites
- LAURUS LABS LIMITEDAnakapalli, IND · 4 sites
- BDR PHARMACEUTICALS INTERNATIONAL PRIVATE LIMITEDVadodara, IND · 3 sites
- Viatris Inc.Hyderabad, IND · 2 sites
- Zydus Lifesciences LimitedVadodara, IND · 2 sites
- Biocon Biologics LimitedAnakapalli, IND · 2 sites
- Viyash Scientific LimitedAnakapalli, IND; Hyderabad, IND · 2 sites
- Granules Pharmaceuticals Inc.Anakapalli, IND · 2 sites
- Matrix Pharmacorp Private LimitedHyderabad, IND · 2 sites
- GLAND PHARMA LIMITEDHyderabad, IND · 2 sites
- Sai Life Sciences LimitedHyderabad, IND · 2 sites
- Analys Lab Private LimitedAnakapalli, IND; Hyderabad, IND · 2 sites
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Enquiry
Common questions
- Is Apicore US LLC FDA approved?
- Apicore US LLC holds 4 FDA-registered establishments across 2 countries. 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 Apicore US LLC's drugs manufactured?
- At registered sites in India, the United States. The FDA register lists Anakapalli; Hyderabad; Vadodara; East Windsor Township, NJ. Registered operations: analytical testing, active ingredient (API) manufacture, relabelling, repackaging, sterilize.
- What drugs does Apicore US LLC make?
- 64 products are listed under Apicore US LLC in the openFDA NDC Directory, most often as powder; injection, powder, for solution; injection, powder, lyophilized, for solution. 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.