Is ScieGen Pharmaceuticals India Private Limited FDA approved?

ScieGen Pharmaceuticals India Private Limited holds 3 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 ScieGen Pharmaceuticals India Private Limited's drugs manufactured?

At registered sites in India, the United States. The FDA register lists Hyderabad; Mahabubnagar; Hauppauge, NY. Registered operations: analytical testing, labelling, finished drug manufacture, packaging.

What drugs does ScieGen Pharmaceuticals India Private Limited make?

200 products are listed under ScieGen Pharmaceuticals India Private Limited in the openFDA NDC Directory, most often as tablet; tablet, film coated; capsule. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

ScieGen Pharmaceuticals India Private Limited

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

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Registered sites: 3
Active NDC listings: 200
Labeller names: 7
Live patents: 0
Countries: 2
Base: India

Authorisation

Registered operations

Analytical testing3Labelling2Finished drug manufacture2Packaging2

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
ScieGen Pharmaceuticals India Private Limited	Plot No.70 & 71, Ground Floor, ALEAP Industrial Area, Pragathi Nagar, Hyderabad, Telangana 500090, India (IND)	Analytical testing	3013580504873738457
ScieGen Pharmaceuticals India Private Limited	SY. No. 408 to 412, 418 to 433 & 434 Plot No. 10,11,12,13 & 14 TSIIC, GIP, Polepally(V), Jadcherla, Mahabubnagar, Telangana 509302, India (IND)	Analytical testing, Labelling, Finished drug manufacture, Packaging	3032546867756049272
ScieGen Pharmaceuticals, INC.	330 Oser Avenue, Hauppauge, New York (NY) 11788-3630, United States (USA)	Analytical testing, Labelling, Finished drug manufacture, Packaging	3008298016081212992

Catalogue

Drug listings by form and route

200

200 active NDC listings: 198 human prescription drug, 2 human otc drug. By marketing category: ANDA 200.

Dosage form	NDCs
tablet	78
tablet, film coated	51
capsule	33
tablet, film coated, extended release	23
tablet, extended release	8
tablet, orally disintegrating	4
tablet, delayed release	2
solution	1

Route	NDCs
oral	199
topical	1

Labeller name on the listing	NDCs
sciegen pharmaceuticals, inc.	89
sciegen pharmaceuticals inc	55
sciegen pharmaceuticals, inc	38
sciegen pharmaceuticals, inc.	13
sciegen pharmaceuticals inc	2
sciegen pharmaceuticals,inc.	2
sciegen pharmaceuticals,inc	1

Catalogue

Marketed products

200

Showing 150 of 200.

Brand	Generic name	Form / route	NDC
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	tablet, film coated, oral	50228-451ANDA
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	tablet, film coated, oral	50228-452ANDA
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	tablet, film coated, oral	50228-453ANDA
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	tablet, film coated, oral	50228-454ANDA
Amlodipine and Olmesartan Medoxomil	Amlodipine and Olmesartan Medoxomil	tablet, film coated, oral	50228-365ANDA
Amlodipine and Olmesartan Medoxomil	Amlodipine and Olmesartan Medoxomil	tablet, film coated, oral	50228-366ANDA
Amlodipine and Olmesartan Medoxomil	Amlodipine and Olmesartan Medoxomil	tablet, film coated, oral	50228-367ANDA
Amlodipine and Olmesartan Medoxomil	Amlodipine and Olmesartan Medoxomil	tablet, film coated, oral	50228-368ANDA
Aripiprazole	Aripiprazole	tablet, oral	50228-324ANDA
Aripiprazole	Aripiprazole	tablet, oral	50228-325ANDA
Aripiprazole	Aripiprazole	tablet, oral	50228-326ANDA
Aripiprazole	Aripiprazole	tablet, oral	50228-327ANDA
Aripiprazole	Aripiprazole	tablet, oral	50228-328ANDA
Aripiprazole	Aripiprazole	tablet, oral	50228-329ANDA
Aripiprazole	Aripiprazole orally disintegrating	tablet, oral	50228-330ANDA
Aripiprazole	Aripiprazole orally disintegrating	tablet, oral	50228-331ANDA
Aripiprazole	Aripiprazole	tablet, oral	50228-475ANDA
Aripiprazole	Aripiprazole	tablet, oral	50228-476ANDA
Aripiprazole	Aripiprazole	tablet, oral	50228-477ANDA
Aripiprazole	Aripiprazole	tablet, oral	50228-478ANDA
Aripiprazole	Aripiprazole	tablet, oral	50228-479ANDA
Aripiprazole	Aripiprazole	tablet, oral	50228-480ANDA
Benztropine Mesylate	Benztropine Mesylate	tablet, oral	50228-225ANDA
Benztropine Mesylate	Benztropine Mesylate	tablet, oral	50228-226ANDA
Benztropine Mesylate	Benztropine Mesylate	tablet, oral	50228-227ANDA
Bupropion Hydrochloride (SR)	bupropion hydrochloride	tablet, film coated, extended release, oral	50228-338ANDA
Bupropion Hydrochloride (XL)	bupropion hydrochloride	tablet, film coated, extended release, oral	50228-144ANDA
Bupropion Hydrochloride (XL)	bupropion hydrochloride	tablet, film coated, extended release, oral	50228-145ANDA
Bupropion Hydrochloride SR	bupropion hydrochloride	tablet, film coated, extended release, oral	50228-174ANDA
Bupropion Hydrochloride SR	bupropion hydrochloride	tablet, film coated, extended release, oral	50228-175ANDA
Bupropion Hydrochloride SR	bupropion hydrochloride	tablet, film coated, extended release, oral	50228-176ANDA
CARISOPRODOL	CARISOPRODOL	tablet, oral	50228-109ANDA
Carbidopa and Levodopa	Carbidopa and Levodopa	tablet, oral	50228-457ANDA
Carbidopa and Levodopa	Carbidopa and Levodopa	tablet, oral	50228-458ANDA
Carbidopa and Levodopa	Carbidopa and Levodopa	tablet, oral	50228-459ANDA
Carbidopa and Levodopa	Carbidopa and Levodopa	tablet, extended release, oral	50228-460ANDA
Carbidopa and Levodopa	Carbidopa and Levodopa	tablet, extended release, oral	50228-461ANDA
Celecoxib	Celecoxib	capsule, oral	50228-156ANDA
Celecoxib	Celecoxib	capsule, oral	50228-157ANDA
Celecoxib	Celecoxib	capsule, oral	50228-158ANDA
Celecoxib	Celecoxib	capsule, oral	50228-159ANDA
Clopidogrel bisulfate	Clopidogrel bisulfate	tablet, film coated, oral	50228-121ANDA
Clopidogrel bisulfate	Clopidogrel bisulfate	tablet, film coated, oral	50228-124ANDA
Clotrimazole Topical Solution USP, 1%	Clotrimazole Topical Solution USP, 1%	solution, topical	50228-502ANDA
DILTIAZEM HYDROCHLORIDE	diltiazem hydrochloride	tablet, extended release, oral	50228-495ANDA
DILTIAZEM HYDROCHLORIDE	diltiazem hydrochloride	tablet, extended release, oral	50228-496ANDA
DILTIAZEM HYDROCHLORIDE	diltiazem hydrochloride	tablet, extended release, oral	50228-497ANDA
DILTIAZEM HYDROCHLORIDE	diltiazem hydrochloride	tablet, extended release, oral	50228-498ANDA
DILTIAZEM HYDROCHLORIDE	diltiazem hydrochloride	tablet, extended release, oral	50228-499ANDA
DILTIAZEM HYDROCHLORIDE	diltiazem hydrochloride	tablet, extended release, oral	50228-500ANDA
Diltiazem Hydrochloride	Diltiazem hydrochloride	tablet, oral	50228-481ANDA
Diltiazem Hydrochloride	Diltiazem Hydrochloride	tablet, oral	50228-482ANDA
Diltiazem Hydrochloride	Diltiazem Hydrochloride	tablet, oral	50228-483ANDA
Diltiazem Hydrochloride	Diltiazem Hydrochloride	tablet, oral	50228-484ANDA
Donepezil Hydrochloride	Donepezil Hydrochloride	tablet, film coated, oral	50228-139ANDA
Donepezil Hydrochloride	Donepezil Hydrochloride	tablet, film coated, oral	50228-140ANDA
Droxidopa	droxidopa	capsule, oral	50228-429ANDA
Droxidopa	droxidopa	capsule, oral	50228-430ANDA
Droxidopa	droxidopa	capsule, oral	50228-431ANDA
ENALAPRIL MALEATE	ENALAPRIL MALEATE	tablet, oral	50228-228ANDA
ENALAPRIL MALEATE	ENALAPRIL MALEATE	tablet, oral	50228-229ANDA
ENALAPRIL MALEATE	ENALAPRIL MALEATE	tablet, oral	50228-230ANDA
ENALAPRIL MALEATE	ENALAPRIL MALEATE	tablet, oral	50228-231ANDA
Ethacrynic Acid	Ethacrynic Acid	tablet, oral	50228-334ANDA
Ezetimibe	Ezetimibe	tablet, oral	50228-379ANDA
Fluoxetine	Fluoxetine Hydrochloride	capsule, oral	50228-113ANDA
Fluoxetine	Fluoxetine Hydrochloride	capsule, oral	50228-114ANDA
Fluoxetine	Fluoxetine Hydrochloride	capsule, oral	50228-115ANDA
Fluoxetine	Fluoxetine	tablet, film coated, oral	50228-420ANDA
Fluoxetine	Fluoxetine	tablet, film coated, oral	50228-421ANDA
Fluoxetine	FLUOXETINE HYDROCHLORIDE	tablet, oral	50228-422ANDA
Fluoxetine	FLUOXETINE HYDROCHLORIDE	tablet, oral	50228-638ANDA
Gabapentin	Gabapentin	tablet, oral	50228-177ANDA
Gabapentin	Gabapentin	tablet, oral	50228-178ANDA
Gabapentin	Gabapentin	capsule, oral	50228-179ANDA
Gabapentin	Gabapentin	capsule, oral	50228-180ANDA
Gabapentin	Gabapentin	capsule, oral	50228-181ANDA
Hydralazine Hydrochloride	Hydralazine Hydrochloride	tablet, oral	50228-182ANDA
Hydralazine Hydrochloride	Hydralazine Hydrochloride	tablet, oral	50228-183ANDA
Hydralazine Hydrochloride	Hydralazine Hydrochloride	tablet, oral	50228-184ANDA
Hydralazine Hydrochloride	Hydralazine Hydrochloride	tablet, oral	50228-185ANDA
Hydrochlorothiazide	Hydrochlorothiazide	tablet, oral	50228-111ANDA
Hydrochlorothiazide	Hydrochlorothiazide	tablet, oral	50228-112ANDA
Hydrochlorothiazide	Hydrochlorothiazide	capsule, oral	50228-146ANDA
Irbesartan	Irbesartan	tablet, oral	50228-160ANDA
Irbesartan	Irbesartan	tablet, oral	50228-161ANDA
Irbesartan	Irbesartan	tablet, oral	50228-162ANDA
LACOSAMIDE	LACOSAMIDE	tablet, film coated, oral	50228-192ANDA
LACOSAMIDE	LACOSAMIDE	tablet, film coated, oral	50228-193ANDA
LACOSAMIDE	LACOSAMIDE	tablet, film coated, oral	50228-194ANDA
LACOSAMIDE	LACOSAMIDE	tablet, film coated, oral	50228-195ANDA
Lamotrigine	Lamotrigine	tablet, orally disintegrating, oral	50228-319ANDA
Lamotrigine	Lamotrigine	tablet, orally disintegrating, oral	50228-320ANDA
Lamotrigine	Lamotrigine	tablet, orally disintegrating, oral	50228-321ANDA
Lamotrigine	Lamotrigine	tablet, orally disintegrating, oral	50228-322ANDA
Levetiracetam	Levetiracetam	tablet, film coated, oral	50228-470ANDA
Levetiracetam	Levetiracetam	tablet, film coated, oral	50228-471ANDA
Levetiracetam	Levetiracetam	tablet, film coated, oral	50228-472ANDA
Levetiracetam	Levetiracetam	tablet, film coated, oral	50228-473ANDA
Levetiracetam Extended-Release	levetiracetam	tablet, film coated, extended release, oral	50228-189ANDA
Levetiracetam Extended-Release	levetiracetam	tablet, film coated, extended release, oral	50228-190ANDA
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	tablet, oral	50228-105ANDA
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	tablet, oral	50228-106ANDA
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	tablet, oral	50228-107ANDA
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	tablet, oral	50228-588ANDA
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	tablet, oral	50228-589ANDA
Metaxalone	Metaxalone	tablet, oral	50228-323ANDA
Metaxalone	Metaxalone	tablet, oral	50228-474ANDA
Metformin Hydrochloride	Metformin Hydrochloride Extended-Release Tablets	tablet, film coated, extended release, oral	50228-445ANDA
Metformin Hydrochloride	Metformin Hydrochloride Extended-Release Tablets	tablet, film coated, extended release, oral	50228-446ANDA
Metformin Hydrochloride	Metformin Hydrochloride Extended-Release Tablets	tablet, film coated, extended release, oral	50228-503ANDA
Metformin Hydrochloride	Metformin Hydrochloride Extended-Release Tablets	tablet, film coated, extended release, oral	50228-504ANDA
Metoclopramide	Metoclopramide	tablet, oral	50228-232ANDA
Metoclopramide	Metoclopramide	tablet, oral	50228-233ANDA
Nabumetone	Nabumetone	tablet, oral	50228-465ANDA
Nabumetone	Nabumetone	tablet, oral	50228-466ANDA
Naproxen	Naproxen	tablet, oral	50228-434ANDA
Naproxen	Naproxen	tablet, oral	50228-435ANDA
Naproxen	Naproxen	tablet, oral	50228-436ANDA
Naproxen Sodium	Naproxen Sodium	tablet, oral	50228-432ANDA
Naproxen Sodium	Naproxen Sodium	tablet, oral	50228-433ANDA
Naproxen and esomeprazole magnesium	Naproxen and esomeprazole magnesium	tablet, delayed release, oral	50228-437ANDA
Naproxen and esomeprazole magnesium	Naproxen and esomeprazole magnesium	tablet, delayed release, oral	50228-438ANDA
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE	OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE	tablet, film coated, oral	50228-342ANDA
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE	OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE	tablet, film coated, oral	50228-343ANDA
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE	OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE	tablet, film coated, oral	50228-344ANDA
Omeprazole and Sodium Bicarbonate	Omeprazole and Sodium Bicarbonate	capsule, oral	50228-363ANDA
Omeprazole and Sodium Bicarbonate	Omeprazole and Sodium Bicarbonate	capsule, oral	50228-364ANDA
PIRFENIDONE	PIRFENIDONE	capsule, oral	50228-441ANDA
PIRFENIDONE	PIRFENIDONE	tablet, oral	50228-442ANDA
PIRFENIDONE	PIRFENIDONE	tablet, oral	50228-443ANDA
Phytonadione	Phytonadione	tablet, oral	50228-333ANDA
Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	tablet, oral	50228-126ANDA
Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	tablet, oral	50228-127ANDA
Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	tablet, oral	50228-128ANDA
Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	tablet, oral	50228-129ANDA
Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	tablet, oral	50228-130ANDA
Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	tablet, oral	50228-131ANDA
Pregabalin	PREGABALIN	capsule, oral	50228-350ANDA
Pregabalin	PREGABALIN	capsule, oral	50228-351ANDA
Pregabalin	PREGABALIN	capsule, oral	50228-352ANDA
Pregabalin	PREGABALIN	capsule, oral	50228-353ANDA
Pregabalin	PREGABALIN	capsule, oral	50228-354ANDA
Pregabalin	PREGABALIN	capsule, oral	50228-355ANDA
Pregabalin	PREGABALIN	capsule, oral	50228-356ANDA
Pregabalin	PREGABALIN	capsule, oral	50228-357ANDA
Pregabalin	PREGABALIN	capsule, oral	50228-645ANDA
Pregabalin	PREGABALIN	capsule, oral	50228-646ANDA
Pregabalin	PREGABALIN	capsule, oral	50228-647ANDA
Pregabalin	PREGABALIN	capsule, oral	50228-648ANDA

Neighbours

Registered in the same town

Hetero Labs LimitedHyderabad, IND; Mahabubnagar, IND · 3 sites
Viatris Inc.Hyderabad, IND · 2 sites
Matrix Pharmacorp Private LimitedHyderabad, IND · 2 sites
SHILPA MEDICARE LIMITEDHyderabad, IND; Mahabubnagar, 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
Amneal Pharmaceuticals of New York, LLCHauppauge, NY

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Enquiry

Common questions

Is ScieGen Pharmaceuticals India Private Limited FDA approved?: ScieGen Pharmaceuticals India Private Limited holds 3 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 ScieGen Pharmaceuticals India Private Limited's drugs manufactured?: At registered sites in India, the United States. The FDA register lists Hyderabad; Mahabubnagar; Hauppauge, NY. Registered operations: analytical testing, labelling, finished drug manufacture, packaging.
What drugs does ScieGen Pharmaceuticals India Private Limited make?: 200 products are listed under ScieGen Pharmaceuticals India Private Limited in the openFDA NDC Directory, most often as tablet; tablet, film coated; 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.