Is Aurore Pharmaceuticals Private Limited FDA approved?

Aurore Pharmaceuticals Private Limited holds 1 FDA-registered establishment 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 Aurore Pharmaceuticals Private Limited's drugs manufactured?

The FDA register lists Hyderabad. Registered operations: active ingredient (API) manufacture.

What drugs does Aurore Pharmaceuticals Private Limited make?

33 products are listed under Aurore Pharmaceuticals Private Limited in the openFDA NDC Directory, most often as powder. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Aurore Pharmaceuticals Private Limited

Data as of 24 Sept 2026 · How to read this entry

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Registered sites: 1
Active NDC listings: 33
Labeller names: 3
Live patents: 0
Countries: 1
Base: India

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
AURORE PHARMACEUTICALS PRIVATE LIMITEDRegistrant: Aurore Pharmaceuticals Private Limited	(Unit-I), Plot Nos. 35,36,38 to 40, 49 to 51, Phase IV, IDA, Jeedimetla,, Hyderabad, Telangana 500055, India (IND)	Active ingredient (API) manufacture	3003937580916568827

Catalogue

Drug listings by form and route

33 active NDC listings: 33 bulk ingredient. By marketing category: BULK INGREDIENT 33.

Dosage form	NDCs
powder	33

Route	NDCs

Labeller name on the listing	NDCs
aurore pharmaceuticals private limited	24
aurore pharmaceuticals private limited	8
aurore pharmaceuticals private limited	1

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	AMLODIPINE BESYLATE	powder	72761-034BULK INGREDIENT
-	ARMODANFINIL	powder	72761-001BULK INGREDIENT
-	CANDESARTAN CILEXETIL	powder	72761-002BULK INGREDIENT
-	CARVEDILOL	powder	72761-004BULK INGREDIENT
-	Citalopram Hydrobromide	powder	72761-006BULK INGREDIENT
-	Clozapine	powder	72761-041BULK INGREDIENT
-	Emtricitabine	powder	72761-008BULK INGREDIENT
-	Emtricitabine (Process -II)	powder	72761-007BULK INGREDIENT
-	Escitalopram oxalate	powder	72761-009BULK INGREDIENT
-	Esomeprazole Magnesium	powder	72761-011BULK INGREDIENT
-	Esomeprazole Magnesium Trihydrate	powder	72761-010BULK INGREDIENT
-	Esomprazole Magnesium	powder	72761-012BULK INGREDIENT
-	Eszopiclone	powder	72761-013BULK INGREDIENT
-	Indomethacin	powder	72761-040BULK INGREDIENT
-	Itraconazole	powder	72761-019BULK INGREDIENT
-	Levothyroxine Sodium	powder	72761-026BULK INGREDIENT
-	MODAFINIL	powder	72761-023BULK INGREDIENT
-	Mirtazapine Anhydrous	powder	72761-015BULK INGREDIENT
-	NAFAMOSTAT MESYLATE JP	powder	72761-028BULK INGREDIENT
-	Oxcarbazepine	powder	72761-033BULK INGREDIENT
-	REMDESIVIR	powder	72761-031BULK INGREDIENT
-	RILPIVIRINE HYDROCHLORIDE	powder	72761-038BULK INGREDIENT
-	SALSALATE	powder	72761-027BULK INGREDIENT
-	Sulindac	powder	72761-042BULK INGREDIENT
-	TOFACITINIB CITRATE	powder	72761-036BULK INGREDIENT
-	TOLVAPTAN	powder	72761-032BULK INGREDIENT
-	Tadalafil	powder	72761-017BULK INGREDIENT
-	Telmisartan	powder	72761-021BULK INGREDIENT
-	VALACYCLOVIR HYDROCHLORIDE	powder	72761-025BULK INGREDIENT
-	VALGANCICLOVIR HCl	powder	72761-029BULK INGREDIENT
-	VERAPAMIL HYDROCHLORIDE	powder	72761-030BULK INGREDIENT
-	Venlafaxine Hydrochloride	powder	72761-018BULK INGREDIENT
-	cromolyn sodium	powder	72761-039BULK INGREDIENT

Neighbours

Registered in the same town

Viatris Inc.Hyderabad, IND · 2 sites
Matrix Pharmacorp Private LimitedHyderabad, IND · 2 sites
GLAND PHARMA LIMITEDHyderabad, IND · 2 sites
Sai Life Sciences LimitedHyderabad, IND · 2 sites
AKRON FORMULATIONS INDIA PRIVATE LIMITEDHyderabad, IND · 2 sites
DifGen Pharmaceuticals LLCHyderabad, IND · 2 sites
Jeevan Scientific Technology LimitedHyderabad, IND · 2 sites
STARTECH LABS PRIVATE LIMITEDHyderabad, IND · 2 sites
VENKAR CHEMICALS PRIVATE LIMITEDHyderabad, IND · 2 sites
Viyash Scientific LimitedHyderabad, IND
Hetero Labs LimitedHyderabad, IND
Indoco Remedies LimitedHyderabad, IND

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Biophore India Pharmaceuticals Private Limited1 site · 38 NDC
APISTER LIFESCIENCES PRIVATE LIMITED1 site · 32 NDC

Enquiry

Common questions

Is Aurore Pharmaceuticals Private Limited FDA approved?: Aurore Pharmaceuticals Private Limited holds 1 FDA-registered establishment 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 Aurore Pharmaceuticals Private Limited's drugs manufactured?: The FDA register lists Hyderabad. Registered operations: active ingredient (API) manufacture.
What drugs does Aurore Pharmaceuticals Private Limited make?: 33 products are listed under Aurore Pharmaceuticals Private Limited in the openFDA NDC Directory, most often as powder. 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.