Is Ajanta Pharma Limited FDA approved?

Ajanta Pharma 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 Ajanta Pharma Limited's drugs manufactured?

The FDA register lists Bharuch; Chhatrapati Sambhajinagar. Registered operations: finished drug manufacture.

What drugs does Ajanta Pharma Limited make?

168 products are listed under Ajanta Pharma Limited in the openFDA NDC Directory, most often as tablet; tablet, extended release; capsule. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Ajanta Pharma Limited

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

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Registered sites: 2
Active NDC listings: 168
Live patents: 0
Countries: 1
Base: India

Authorisation

Registered operations

Finished drug manufacture2

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Ajanta Pharma Limited	Plot No. Z-103 /A Dahej SEZ - Part II, Bharuch, Gujarat 392130, India (IND)	Finished drug manufacture	3012664809862199968
Ajanta Pharma Limited	B-4\5\6, MIDC Area, Paithan, Chhatrapati Sambhajinagar, Maharashtra 431148, India (IND)	Finished drug manufacture	3006785788918594859

Catalogue

Drug listings by form and route

168

168 active NDC listings: 168 human prescription drug. By marketing category: ANDA 168.

Dosage form	NDCs
tablet	67
tablet, extended release	27
capsule	23
capsule, extended release	13
tablet, film coated	12
capsule, delayed release	6
for suspension	5
tablet, orally disintegrating	4
powder, for suspension	2
tablet, chewable	2
tablet, delayed release	2
capsule, coated pellets	1
granule	1
kit	1
powder, for solution	1

Route	NDCs
oral	167

Labeller name on the listing	NDCs
ajanta pharma usa inc.	168

Catalogue

Marketed products

168

Showing 150 of 168.

Brand	Generic name	Form / route	NDC
Acetazolamide	Acetazolamide	tablet, oral	27241-132ANDA
Acetazolamide	Acetazolamide	tablet, oral	27241-133ANDA
Amlodipine besylate and Olmesartan medoxomil	Amlodipine besylate and Olmesartan medoxomil	tablet, oral	27241-083ANDA
Amlodipine besylate and Olmesartan medoxomil	Amlodipine besylate and Olmesartan medoxomil	tablet, oral	27241-084ANDA
Amlodipine besylate and Olmesartan medoxomil	Amlodipine besylate and Olmesartan medoxomil	tablet, oral	27241-085ANDA
Amlodipine besylate and Olmesartan medoxomil	Amlodipine besylate and Olmesartan medoxomil	tablet, oral	27241-086ANDA
Aripiprazole	Aripiprazole	tablet, oral	27241-051ANDA
Aripiprazole	Aripiprazole	tablet, oral	27241-052ANDA
Aripiprazole	Aripiprazole	tablet, oral	27241-053ANDA
Aripiprazole	Aripiprazole	tablet, oral	27241-054ANDA
Aripiprazole	Aripiprazole	tablet, oral	27241-055ANDA
Aripiprazole	Aripiprazole	tablet, oral	27241-056ANDA
Brexpiprazole	Brexpiprazole	tablet, oral	27241-204ANDA
Brexpiprazole	Brexpiprazole	tablet, oral	27241-205ANDA
Brexpiprazole	Brexpiprazole	tablet, oral	27241-206ANDA
Brexpiprazole	Brexpiprazole	tablet, oral	27241-207ANDA
Brexpiprazole	Brexpiprazole	tablet, oral	27241-208ANDA
Brexpiprazole	Brexpiprazole	tablet, oral	27241-209ANDA
Captopril	Captopril	tablet, oral	27241-160ANDA
Captopril	Captopril	tablet, oral	27241-161ANDA
Captopril	Captopril	tablet, oral	27241-162ANDA
Captopril	Captopril	tablet, oral	27241-163ANDA
Carbamazepine	Carbamazepine	tablet, extended release, oral	27241-231ANDA
Carbamazepine	Carbamazepine	tablet, extended release, oral	27241-232ANDA
Carbamazepine	Carbamazepine	tablet, extended release, oral	27241-233ANDA
Chlorthalidone	Chlorthalidone	tablet, oral	27241-216ANDA
Chlorthalidone	Chlorthalidone	tablet, oral	27241-217ANDA
Cholestyramine	Cholestyramine	powder, for suspension, oral	27241-134ANDA
Clomipramine hydrochloride	Clomipramine hydrochloride	capsule, oral	27241-210ANDA
Clomipramine hydrochloride	Clomipramine hydrochloride	capsule, oral	27241-211ANDA
Clomipramine hydrochloride	Clomipramine hydrochloride	capsule, oral	27241-212ANDA
Clonidine hydrochloride	Clonidine hydrochloride	tablet, extended release, oral	27241-108ANDA
Dapagliflozin	Dapagliflozin	tablet, oral	27241-151ANDA
Dapagliflozin	Dapagliflozin	tablet, oral	27241-152ANDA
Divalproex sodium	Divalproex sodium	capsule, coated pellets, oral	27241-115ANDA
Doxepin	Doxepin	tablet, oral	27241-280ANDA
Doxepin	Doxepin	tablet, oral	27241-281ANDA
Doxepin hydrochloride	Doxepin hydrochloride	capsule, oral	27241-167ANDA
Doxepin hydrochloride	Doxepin hydrochloride	capsule, oral	27241-168ANDA
Doxepin hydrochloride	Doxepin hydrochloride	capsule, oral	27241-169ANDA
Doxepin hydrochloride	Doxepin hydrochloride	capsule, oral	27241-170ANDA
Doxepin hydrochloride	Doxepin hydrochloride	capsule, oral	27241-171ANDA
Doxycycline Hyclate	Doxycycline Hyclate	capsule, oral	27241-140ANDA
Doxycycline Hyclate	Doxycycline Hyclate	capsule, oral	27241-141ANDA
Doxycycline hyclate	Doxycycline hyclate	tablet, oral	27241-153ANDA
Doxycycline hyclate	Doxycycline hyclate	tablet, oral	27241-154ANDA
Duloxetine	Duloxetine	capsule, delayed release, oral	27241-097ANDA
Duloxetine	Duloxetine	capsule, delayed release, oral	27241-098ANDA
Duloxetine	Duloxetine	capsule, delayed release, oral	27241-099ANDA
Duloxetine	Duloxetine	capsule, delayed release, oral	27241-164ANDA
Entacapone	Entacapone	tablet, oral	27241-049ANDA
Famotidine	Famotidine	for suspension, oral	27241-249ANDA
Fenofibrate	Fenofibrate	capsule, oral	27241-118ANDA
Fenofibrate	Fenofibrate	capsule, oral	27241-119ANDA
Fenofibrate	Fenofibrate	capsule, oral	27241-120ANDA
Fluphenazine hydrochloride	Fluphenazine hydrochloride	tablet, oral	27241-252ANDA
Fluphenazine hydrochloride	Fluphenazine hydrochloride	tablet, oral	27241-253ANDA
Fluphenazine hydrochloride	Fluphenazine hydrochloride	tablet, oral	27241-254ANDA
Fluphenazine hydrochloride	Fluphenazine hydrochloride	tablet, oral	27241-255ANDA
Fluvoxamine Maleate	Fluvoxamine Maleate	capsule, extended release, oral	27241-274ANDA
Fluvoxamine Maleate	Fluvoxamine Maleate	capsule, extended release, oral	27241-275ANDA
Guanfacine	Guanfacine	tablet, oral	27241-242ANDA
Guanfacine	Guanfacine	tablet, oral	27241-243ANDA
Ivermectin	Ivermectin	tablet, oral	27241-293ANDA
Ketorolac Tromethamine	ketorolac tromethamine	tablet, film coated, oral	27241-316ANDA
Lamotrigine	Lamotrigine	tablet, orally disintegrating, oral	27241-183ANDA
Lamotrigine	Lamotrigine	tablet, orally disintegrating, oral	27241-184ANDA
Lamotrigine	Lamotrigine	tablet, orally disintegrating, oral	27241-185ANDA
Lamotrigine	Lamotrigine	tablet, orally disintegrating, oral	27241-186ANDA
Lansoprazole	Lansoprazole	capsule, delayed release, oral	27241-019ANDA
Lansoprazole	Lansoprazole	capsule, delayed release, oral	27241-020ANDA
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE	metoprolol tartrate and hydrochlorothiazide	tablet, oral	27241-301ANDA
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE	metoprolol tartrate and hydrochlorothiazide	tablet, oral	27241-302ANDA
MONTELUKAST SODIUM	MONTELUKAST SODIUM	granule, oral	27241-015ANDA
MONTELUKAST SODIUM	MONTELUKAST SODIUM	tablet, chewable, oral	27241-016ANDA
MONTELUKAST SODIUM	MONTELUKAST	tablet, chewable, oral	27241-017ANDA
MONTELUKAST SODIUM	MONTELUKAST SODIUM	tablet, coated, oral	27241-018ANDA
Memantine Hydrochloride	Memantine Hydrochloride	tablet, oral	27241-070ANDA
Memantine Hydrochloride	Memantine Hydrochloride	tablet, oral	27241-071ANDA
Metformin hydrochloride	Metformin hydrochloride	tablet, extended release, oral	27241-188ANDA
Metformin hydrochloride	Metformin hydrochloride	tablet, extended release, oral	27241-189ANDA
Metformin hydrochloride	Metformin hydrochloride	tablet, extended release, oral	27241-240ANDA
Metformin hydrochloride	Metformin hydrochloride	tablet, extended release, oral	27241-241ANDA
Methazolamide	Methazolamide	tablet, oral	27241-246ANDA
Methazolamide	Methazolamide	tablet, oral	27241-247ANDA
Naproxen and esomeprazole magnesium	Naproxen and esomeprazole magnesium	tablet, delayed release, oral	27241-202ANDA
Naproxen and esomeprazole magnesium	Naproxen and esomeprazole magnesium	tablet, delayed release, oral	27241-203ANDA
Omeprazole and Sodium Bicarbonate	Omeprazole and Sodium Bicarbonate	for suspension, oral	27241-029ANDA
Omeprazole and Sodium Bicarbonate	Omeprazole and Sodium Bicarbonate	for suspension, oral	27241-030ANDA
Omeprazole and Sodium Bicarbonate	Omeprazole and Sodium Bicarbonate	capsule, oral	27241-031ANDA
Omeprazole and Sodium Bicarbonate	Omeprazole and Sodium Bicarbonate	capsule, oral	27241-032ANDA
Oseltamivir phosphate	Oseltamivir phosphate	for suspension, oral	27241-139ANDA
Oxcarbazepine	Oxcarbazepine	tablet, extended release, oral	27241-237ANDA
Oxcarbazepine	Oxcarbazepine	tablet, extended release, oral	27241-238ANDA
Oxcarbazepine	Oxcarbazepine	tablet, extended release, oral	27241-239ANDA
Oxybutynin Chloride	Oxybutynin Chloride	tablet, extended release, oral	27241-155ANDA
Oxybutynin Chloride	Oxybutynin Chloride	tablet, extended release, oral	27241-156ANDA
Oxybutynin Chloride	Oxybutynin Chloride	tablet, extended release, oral	27241-157ANDA
Paliperidone	Paliperidone	tablet, extended release, oral	27241-276ANDA
Paliperidone	Paliperidone	tablet, extended release, oral	27241-277ANDA
Paliperidone	Paliperidone	tablet, extended release, oral	27241-278ANDA
Paliperidone	Paliperidone	tablet, extended release, oral	27241-279ANDA
Pantoprazole sodium	Pantoprazole sodium	for suspension, oral	27241-256ANDA
Prochlorperazine Maleate	Prochlorperazine Maleate	tablet, oral	27241-286ANDA
Prochlorperazine Maleate	Prochlorperazine Maleate	tablet, oral	27241-287ANDA
Prucalopride	Prucalopride	tablet, oral	27241-294ANDA
Prucalopride	Prucalopride	tablet, oral	27241-295ANDA
RISPERIDONE	RISPERIDONE	tablet, oral	27241-001ANDA
RISPERIDONE	RISPERIDONE	tablet, oral	27241-002ANDA
RISPERIDONE	RISPERIDONE	tablet, oral	27241-003ANDA
RISPERIDONE	RISPERIDONE	tablet, oral	27241-004ANDA
RISPERIDONE	RISPERIDONE	tablet, oral	27241-005ANDA
RISPERIDONE	RISPERIDONE	tablet, oral	27241-006ANDA
Ranitidine	Ranitidine	capsule, oral	27241-109ANDA
Ranitidine	Ranitidine	capsule, oral	27241-110ANDA
Ranolazine	Ranolazine	tablet, extended release, oral	27241-125ANDA
Ranolazine	Ranolazine	tablet, extended release, oral	27241-126ANDA
Sildenafil	Sildenafil	tablet, oral	27241-124ANDA
Sildenafil	Sildenafil	powder, for suspension, oral	27241-175ANDA
Sildenafil Citrate	Sildenafil	tablet, film coated, oral	27241-067ANDA
Sildenafil Citrate	Sildenafil	tablet, film coated, oral	27241-068ANDA
Sildenafil Citrate	Sildenafil	tablet, film coated, oral	27241-069ANDA
Silodosin	Silodosin	capsule, oral	27241-144ANDA
Silodosin	Silodosin	capsule, oral	27241-145ANDA
Tadalafil	Tadalafil	tablet, oral	27241-111ANDA
Tadalafil	Tadalafil	tablet, oral	27241-112ANDA
Tadalafil	Tadalafil	tablet, oral	27241-113ANDA
Tadalafil	Tadalafil	tablet, oral	27241-114ANDA
Tadalafil	Tadalafil	tablet, oral	27241-123ANDA
Terazosin	Terazosin	capsule, oral	27241-288ANDA
Terazosin	Terazosin	capsule, oral	27241-289ANDA
Terazosin	Terazosin	capsule, oral	27241-290ANDA
Terazosin	Terazosin	capsule, oral	27241-291ANDA
Tetrabenazine	Tetrabenazine	tablet, oral	27241-176ANDA
Tetrabenazine	Tetrabenazine	tablet, oral	27241-177ANDA
Theophylline	Theophylline	tablet, extended release, oral	27241-272ANDA
Theophylline	Theophylline	tablet, extended release, oral	27241-273ANDA
Tofacitinib	Tofacitinib	tablet, extended release, oral	27241-270ANDA
Tolterodine tartrate	Tolterodine tartrate	capsule, extended release, oral	27241-191ANDA
Tolterodine tartrate	Tolterodine tartrate	capsule, extended release, oral	27241-192ANDA
Topiramate	Topiramate	capsule, extended release, oral	27241-227ANDA
Topiramate	Topiramate	capsule, extended release, oral	27241-228ANDA
Topiramate	Topiramate	capsule, extended release, oral	27241-229ANDA
Topiramate	Topiramate	capsule, extended release, oral	27241-230ANDA
Topiramate	Topiramate	capsule, extended release, oral	27241-296ANDA
Topiramate	Topiramate	capsule, extended release, oral	27241-297ANDA
Topiramate	Topiramate	capsule, extended release, oral	27241-298ANDA
Topiramate	Topiramate	capsule, extended release, oral	27241-299ANDA
Topiramate	Topiramate	capsule, extended release, oral	27241-300ANDA
Valganciclovir	Valganciclovir	tablet, oral	27241-158ANDA

Neighbours

Registered in the same town

HARMAN FINOCHEM LIMITEDChhatrapati Sambhajinagar, IND · 4 sites
Unique Pharmaceutical Laboratories (A Div. of JB Chemicals & Pharmaceuticals Ltd)Bharuch, IND · 3 sites
Sun Pharmaceutical Industries LimitedBharuch, IND · 2 sites
Alkem Laboratories LimitedBharuch, IND · 2 sites
Meghmani LLPBHARUCH, IND; Bharuch, IND · 2 sites
Viatris Inc.Chhatrapati Sambhajinagar, IND
Lupin LimitedChhatrapati Sambhajinagar, IND
Glenmark Pharmaceuticals Inc., USABharuch, IND
Indoco Remedies LimitedChhatrapati Sambhajinagar, IND
Ipca Laboratories LimitedChhatrapati Sambhajinagar, IND
Intas Pharmaceuticals LimitedBharuch, IND
Macleods Pharmaceuticals LimitedBharuch, IND

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Enquiry

Common questions

Is Ajanta Pharma Limited FDA approved?: Ajanta Pharma 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 Ajanta Pharma Limited's drugs manufactured?: The FDA register lists Bharuch; Chhatrapati Sambhajinagar. Registered operations: finished drug manufacture.
What drugs does Ajanta Pharma Limited make?: 168 products are listed under Ajanta Pharma Limited in the openFDA NDC Directory, most often as tablet; tablet, extended release; 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.