Is Hikal Limited FDA approved?

Hikal Limited holds 2 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 Hikal Limited's drugs manufactured?

The FDA register lists Bengaluru; Bharuch. Registered operations: active ingredient (API) manufacture.

What drugs does Hikal Limited make?

35 products are listed under Hikal 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.

Hikal Limited

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

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Registered sites: 2
Active NDC listings: 35
Live patents: 0
Countries: 1
Base: India

Authorisation

Registered operations

Active ingredient (API) manufacture2

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Hikal Limited	72 & 82/A, KIADB Industrial Area Jigani, Anekal Taluk, Bengaluru, Karnataka 560105, India (IND)	Active ingredient (API) manufacture	3003560263918602129
Hikal Limited	Plot No. 629/630-B, GIDC Estate, Panoli, Bharuch, Gujarat 394116, India (IND)	Active ingredient (API) manufacture	3009627283918602111

Catalogue

Drug listings by form and route

35 active NDC listings: 35 bulk ingredient. By marketing category: BULK INGREDIENT 35.

Dosage form	NDCs
powder	35

Route	NDCs

Labeller name on the listing	NDCs
hikal limited	35

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	APIXABAN	powder	66651-921BULK INGREDIENT
-	BUPROPION HYDROCHLORIDE	powder	66651-501BULK INGREDIENT
-	BUPROPION HYDROCHLORIDE	powder	66651-902BULK INGREDIENT
-	BUTORPHANOL TARTRATE	powder	66651-920BULK INGREDIENT
-	Bupropion Hydrobromide	powder	66651-929BULK INGREDIENT
-	Bupropion Hydrobromide	powder	66651-930BULK INGREDIENT
-	CELECOXIB	powder	66651-502BULK INGREDIENT
-	CELECOXIB	powder	66651-919BULK INGREDIENT
-	Cariprazine Hydrochloride	powder	66651-935BULK INGREDIENT
-	DABIGATRAN ETEXILATE MESYLATE	powder	66651-918BULK INGREDIENT
-	DAPAGLIFLOZIN PROPANEDIOL	powder	66651-924BULK INGREDIENT
-	DECOQUINATE	powder	66651-907BULK INGREDIENT
-	Desvenlafaxine Succinate	powder	66651-928BULK INGREDIENT
-	ERTUGLIFLOZIN	powder	66651-926BULK INGREDIENT
-	Edoxaban Tosylate Monohydrate	powder	66651-932BULK INGREDIENT
-	GABAPENTIN	powder	66651-901BULK INGREDIENT
-	GEMFIBROZIL	powder	66651-905BULK INGREDIENT
-	LACOSAMIDE	powder	66651-914BULK INGREDIENT
-	Lubabegron fumarate	powder	66651-933BULK INGREDIENT
-	MEMANTINE HYDROCHLORIDE	powder	66651-909BULK INGREDIENT
-	ONDANSETRON	powder	66651-904BULK INGREDIENT
-	ONDANSETRON HYDROCHLORIDE	powder	66651-903BULK INGREDIENT
-	PENTOXIFYLLINE	powder	66651-912BULK INGREDIENT
-	PREGABALIN	powder	66651-915BULK INGREDIENT
-	PYRIMETHAMINE	powder	66651-922BULK INGREDIENT
-	QUETIAPINE FUMARATE	powder	66651-910BULK INGREDIENT
-	Rivaroxaban	powder	66651-503BULK INGREDIENT
-	SITAGLIPTIN HYDROCHLORIDE	powder	66651-923BULK INGREDIENT
-	SITAGLIPTIN PHOSPHATE	powder	66651-917BULK INGREDIENT
-	SITAGLIPTIN PHOSPHATE ANHYDRATE	powder	66651-925BULK INGREDIENT
-	TRIPROLIDINE HYDROCHLORIDE	powder	66651-906BULK INGREDIENT
-	VALACYCLOVIR HYDROCHLORIDE	powder	66651-916BULK INGREDIENT
-	VENLAFAXINE HYDROCHLORIDE	powder	66651-908BULK INGREDIENT
-	Vildagliptin	powder	66651-102BULK INGREDIENT
-	Vonoprazan Fumarate	powder	66651-934BULK INGREDIENT

Neighbours

Registered in the same town

Biocon Biologics LimitedBengaluru, IND · 5 sites
Micro Labs LimitedBengaluru, IND · 4 sites
Syngene International LimitedBengaluru, IND · 3 sites
Unique Pharmaceutical Laboratories (A Div. of JB Chemicals & Pharmaceuticals Ltd)Bharuch, IND · 3 sites
Sun Pharmaceutical Industries LimitedBharuch, IND · 2 sites
CIPLA PHARMACEUTICALS LIMITEDBengaluru, IND · 2 sites
SHILPA MEDICARE LIMITEDBengaluru, IND · 2 sites
Alkem Laboratories LimitedBharuch, 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
Meghmani LLPBHARUCH, IND; Bharuch, IND · 2 sites

Compare

Comparable companies in India

MSN Life Sciences Private Limited2 sites · 167 NDC
Sionc Pharmaceuticals Private Limited2 sites · 56 NDC
Symbiotec Pharmalab Limited2 sites · 53 NDC
SMS Pharmaceuticals Limited2 sites · 46 NDC
DIVI'S LABORATORIES LIMITED2 sites · 45 NDC
Chromo Laboratories India Private Limited2 sites · 44 NDC
SHILPA PHARMA LIFESCIENCES LIMITED2 sites · 40 NDC
Teva API India Private Ltd.2 sites · 36 NDC
Optimus Drugs Private Limited2 sites · 32 NDC
Amoli Organics (A Division of Umedica Laboratories Pvt. Ltd.)2 sites · 29 NDC

Enquiry

Common questions

Is Hikal Limited FDA approved?: Hikal Limited holds 2 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 Hikal Limited's drugs manufactured?: The FDA register lists Bengaluru; Bharuch. Registered operations: active ingredient (API) manufacture.
What drugs does Hikal Limited make?: 35 products are listed under Hikal 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.