Is Strides Pharma Science Limited FDA approved?

Strides Pharma Science Limited holds 5 FDA-registered establishments across 3 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 Strides Pharma Science Limited's drugs manufactured?

At registered sites in India, Italy, the United States. The FDA register lists Bengaluru; Chengalpattu; Puducherry; CUSANO MILANINO; Chestnut Ridge, NY. Registered operations: analytical testing, finished drug manufacture, packaging.

What drugs does Strides Pharma Science Limited make?

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

Strides Pharma Science Limited

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

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Registered sites: 5
Active NDC listings: 230
Labeller names: 5
Live patents: 15
Shortage listings: 1
Countries: 3
Base: India

Authorisation

Registered operations

Analytical testing4Finished drug manufacture5Packaging5

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Strides Pharma Science Limited	No 36/7,Suragajakkanahalli, Indlavadi Cross, Anekal Taluk, Bengaluru, Karnataka 562106, India (IND)	Analytical testing, Finished drug manufacture, Packaging	3004554612918513263
Strides Pharma Science Limited	Plot No. 101 to 108 & 153, SIDCO Pharmaceutical Complex, Alathur, Chengalpattu, Tamil Nadu 603110, India (IND)	Analytical testing, Finished drug manufacture, Packaging	3005151016860477684
Strides Pharma Science Limited	R. S. No. 31, 32 and 33 PIMS Road, Periyakalapet, Puducherry, Puducherry 605014, India (IND)	Analytical testing, Finished drug manufacture, Packaging	3012448465871402375
Beltapharm SPARegistrant: Strides Pharma Science Limited	VIA STELVIO 66, CUSANO MILANINO, MILANO 20095, Italy (ITA)	Finished drug manufacture, Packaging	3009853808429236789
Strides Pharma, IncRegistrant: Strides Pharma Science Limited	1 Ram Ridge Rd, Chestnut Ridge, New York (NY) 10977-6714, United States (USA)	Analytical testing, Finished drug manufacture, Packaging	2434223118344504

Alert

Drug shortage listings

Drug	Presentation	Status	Availability	Posted / updated
Ursodiol CapsuleOther	Ursodiol, Capsule, 300 mg (NDC 64380-844-06)	To Be Discontinued	-	6 Apr 20266 Apr 2026

Catalogue

Drug listings by form and route

230

230 active NDC listings: 214 human prescription drug, 16 human otc drug. By marketing category: ANDA 224, OTC MONOGRAPH DRUG 3, NDA AUTHORIZED GENERIC 2, UNAPPROVED DRUG OTHER 1.

Dosage form	NDCs
tablet	100
capsule	42
tablet, film coated	31
capsule, liquid filled	11
powder, for solution	8
tablet, coated	6
tablet, orally disintegrating	5
powder, for suspension	4
tablet, extended release	4
capsule, extended release	3
cream	3
suspension	3
for suspension	2
gel	2
ointment	2

Route	NDCs
oral	222
topical	5
transdermal	2
subcutaneous	1

Labeller name on the listing	NDCs
strides pharma science limited	195
strides pharma inc.	19
strides pharma inc	11
strides consumer llc	3
strides pharma, inc.	2

Exclusivity

Patents and exclusivities

Patent	Product	Covers	Expiry
10792262	LYVISPAHbaclofen	product	Jul 2039
11654124	LYVISPAHbaclofen	product	Jul 2039
11931328	LYVISPAHbaclofen	product	Jul 2039
11491125	LYVISPAHbaclofen	product	Sept 2041
11850225	LYVISPAHbaclofen	product	Sept 2041

Catalogue

Marketed products

230

Showing 150 of 230.

Brand	Generic name	Form / route	NDC
AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE	amlodipine besylate valsartan hydrochlorothiazide	tablet, film coated, oral	64380-197ANDA
AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE	amlodipine besylate valsartan hydrochlorothiazide	tablet, film coated, oral	64380-198ANDA
AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE	amlodipine besylate valsartan hydrochlorothiazide	tablet, film coated, oral	64380-199ANDA
AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE	amlodipine besylate valsartan hydrochlorothiazide	tablet, film coated, oral	64380-200ANDA
AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE	amlodipine besylate valsartan hydrochlorothiazide	tablet, film coated, oral	64380-201ANDA
Acarbose	acarbose	tablet, oral	64380-758ANDA
Acarbose	acarbose	tablet, oral	64380-759ANDA
Acarbose	acarbose	tablet, oral	64380-760ANDA
Acetaminophen and Codeine Phosphate	Acetaminophen and Codeine Phosphate	tablet, oral	64380-446ANDA
Acetaminophen and Codeine Phosphate	Acetaminophen and Codeine Phosphate	tablet, oral	64380-447ANDA
Acetaminophen and Codeine Phosphate	Acetaminophen and Codeine Phosphate	tablet, oral	64380-448ANDA
Acetazolamide	Acetazolamide	tablet, oral	64380-833ANDA
Acetazolamide	Acetazolamide	tablet, oral	64380-834ANDA
Amantadine Hydrochloride	Amantadine Hydrochloride	capsule, oral	42543-493ANDA
Amantadine Hydrochloride	Amantadine Hydrochloride	tablet, oral	42543-497ANDA
Amantadine Hydrochloride	Amantadine Hydrochloride	capsule, liquid filled, oral	64380-862ANDA
Amlodipine and Valsartan	amlodipine and valsartan	tablet, oral	64380-214ANDA
Amlodipine and Valsartan	amlodipine and valsartan	tablet, oral	64380-215ANDA
Amlodipine and Valsartan	amlodipine and valsartan	tablet, oral	64380-216ANDA
Amlodipine and Valsartan	amlodipine and valsartan	tablet, oral	64380-217ANDA
Atomoxetine	Atomoxetine	capsule, oral	64380-472ANDA
Atomoxetine	Atomoxetine	capsule, oral	64380-473ANDA
Atomoxetine	Atomoxetine	capsule, oral	64380-474ANDA
Atomoxetine	Atomoxetine	capsule, oral	64380-475ANDA
Atomoxetine	Atomoxetine	capsule, oral	64380-476ANDA
Atomoxetine	Atomoxetine	capsule, oral	64380-477ANDA
Atomoxetine	Atomoxetine	capsule, oral	64380-478ANDA
BENZONATATE	BENZONATATE	capsule, oral	64380-712ANDA
BENZONATATE	BENZONATATE	capsule, oral	64380-713ANDA
Buspirone Hydrochloride	Buspirone Hydrochloride	tablet, oral	42543-741ANDA
Buspirone Hydrochloride	Buspirone Hydrochloride	tablet, oral	42543-742ANDA
Buspirone Hydrochloride	Buspirone Hydrochloride	tablet, oral	42543-743ANDA
Buspirone Hydrochloride	Buspirone Hydrochloride	tablet, oral	42543-744ANDA
Buspirone Hydrochloride	Buspirone Hydrochloride	tablet, oral	42543-787ANDA
Buspirone Hydrochloride	Buspirone Hydrochloride	tablet, oral	64380-741ANDA
Buspirone Hydrochloride	Buspirone Hydrochloride	tablet, oral	64380-742ANDA
Buspirone Hydrochloride	Buspirone Hydrochloride	tablet, oral	64380-743ANDA
Buspirone Hydrochloride	Buspirone Hydrochloride	tablet, oral	64380-744ANDA
Buspirone Hydrochloride	Buspirone Hydrochloride	tablet, oral	64380-787ANDA
Butalbital, Acetaminophen and Caffeine	Butalbital, Acetaminophen, and Caffeine	tablet, oral	64380-157ANDA
CELECOXIB	celecoxib	capsule, oral	64380-824ANDA
CYPROHEPTADINE HYDROCHLORIDE	CYPROHEPTADINE HYDROCHLORIDE	tablet, oral	64380-795ANDA
Cabergoline	Cabergoline	tablet, oral	64380-202ANDA
Calcitriol	Calcitriol Capsules 0.25 mcg	capsule, oral	64380-723ANDA
Calcitriol	Calcitriol Capsules 0.5 mcg	capsule, oral	64380-724ANDA
Cinacalcet	Cinacalcet	tablet, film coated, oral	64380-883ANDA
Cinacalcet	Cinacalcet	tablet, film coated, oral	64380-884ANDA
Cinacalcet	Cinacalcet	tablet, film coated, oral	64380-885ANDA
Colchicine	Colchicine	tablet, film coated, oral	64380-796ANDA
Cyclosporine	Cyclosporine	capsule, liquid filled, oral	64380-127ANDA
Cyclosporine	Cyclosporine	capsule, liquid filled, oral	64380-128ANDA
Cyclosporine	Cyclosporine	capsule, liquid filled, oral	64380-129ANDA
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	tablet, oral	64380-225ANDA
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	tablet, oral	64380-226ANDA
Doxepin	doxepin hydrochloride	tablet, oral	64380-203ANDA
Doxepin	doxepin hydrochloride	tablet, oral	64380-204ANDA
Doxycycline	doxycycline	capsule, oral	64380-179ANDA
Doxycycline	doxycycline	capsule, oral	64380-180ANDA
Doxycycline	doxycycline	capsule, oral	64380-181ANDA
Doxycycline	doxycycline	tablet, oral	64380-205ANDA
Doxycycline	doxycycline	tablet, oral	64380-206ANDA
Doxycycline	doxycycline	tablet, oral	64380-207ANDA
Doxycycline	doxycycline	tablet, oral	64380-208ANDA
Doxycycline	doxycycline	capsule, oral	64380-920ANDA
Doxycycline	doxycycline	capsule, oral	64380-921ANDA
Doxycycline	doxycycline	capsule, oral	64380-922ANDA
Doxycycline	doxycycline	capsule, oral	64380-923ANDA
Dutasteride	Dutasteride	capsule, liquid filled, oral	64380-763ANDA
ETHOSUXIMIDE	ETHOSUXIMIDE	capsule, oral	64380-878ANDA
Emtricitabine and Tenofovir Disoproxil Fumarate	EMTRICITABINE and TENOFOVIR Disoproxil Fumarate	tablet, oral	42543-719ANDA
Emtricitabine and Tenofovir Disoproxil Fumarate	EMTRICITABINE and TENOFOVIR Disoproxil Fumarate	tablet, oral	64380-719ANDA
FLUOXETINE	fluoxetine	tablet, oral	64380-902ANDA
FLUOXETINE	fluoxetine	tablet, oral	64380-903ANDA
FLUOXETINE HCL	fluoxetine hcl	tablet, oral	64380-900ANDA
GABAPENTIN	gabapentin	capsule, oral	64380-867ANDA
GABAPENTIN	gabapentin	capsule, oral	64380-868ANDA
GABAPENTIN	gabapentin	capsule, oral	64380-869ANDA
Gabapentin	Gabapentin	tablet, oral	64380-727ANDA
Gabapentin	Gabapentin	tablet, oral	64380-728ANDA
Gabapentin	Gabapentin	capsule, oral	64380-731ANDA
Gabapentin	Gabapentin	capsule, oral	64380-753ANDA
Gabapentin	Gabapentin	capsule, oral	64380-754ANDA
HydrALAZINE Hydrochloride	HydrALAZINE Hydrochloride	tablet, oral	64380-733ANDA
HydrALAZINE Hydrochloride	HydrALAZINE Hydrochloride	tablet, oral	64380-734ANDA
HydrALAZINE Hydrochloride	HydrALAZINE Hydrochloride	tablet, oral	64380-735ANDA
HydrALAZINE Hydrochloride	HydrALAZINE Hydrochloride	tablet, oral	64380-736ANDA
Hydrocortisone	Hydrocortisone	tablet, oral	42543-970ANDA
Hydrocortisone	Hydrocortisone	tablet, oral	42543-971ANDA
Hydrocortisone	Hydrocortisone	tablet, oral	42543-972ANDA
Hydrocortisone	Hydrocortisone	tablet, oral	64380-970ANDA
Hydrocortisone	Hydrocortisone	tablet, oral	64380-971ANDA
Hydrocortisone	Hydrocortisone	tablet, oral	64380-972ANDA
IBUPROFEN	IBUPROFEN	capsule, liquid filled, oral	59556-764ANDA
IBUPROFEN	IBUPROFEN	capsule, liquid filled, oral	59556-895ANDA
IBUPROFEN Immediate Release	IBUPROFEN	tablet, coated, oral	59556-857ANDA
IBUPROFEN Immediate Release	IBUPROFEN	tablet, coated, oral	59556-858ANDA
Ibuprofen	Ibuprofen	tablet, film coated, oral	42543-964ANDA
Ibuprofen	Ibuprofen	tablet, film coated, oral	42543-965ANDA
Ibuprofen	Ibuprofen	tablet, film coated, oral	42543-966ANDA
Ibuprofen	Ibuprofen	tablet, film coated, oral	64380-807ANDA
Ibuprofen	Ibuprofen	tablet, film coated, oral	64380-808ANDA
Ibuprofen	Ibuprofen	tablet, film coated, oral	64380-809ANDA
Ibuprofen	Ibuprofen	suspension, oral	64380-997ANDA
Ibuprofen Immediate Release	Ibuprofen	tablet, coated, oral	59556-855ANDA
Ibuprofen Immediate Release	Ibuprofen	tablet, coated, oral	59556-856ANDA
Imipramine Hydrochloride	Imipramine Hydrochloride	tablet, oral	64380-169ANDA
Imipramine Hydrochloride	Imipramine Hydrochloride	tablet, oral	64380-170ANDA
Imipramine Hydrochloride	Imipramine Hydrochloride	tablet, oral	64380-171ANDA
Jointflex	Jointflex	cream, topical	72927-904OTC MONOGRAPH DRUG
Jointflex	Camphor	cream, topical	72927-944OTC MONOGRAPH DRUG
Jointflex	Camphor	cream, topical	72927-976OTC MONOGRAPH DRUG
KETOCONAZOLE	KETOCONAZOLE	tablet, oral	64380-827ANDA
LORATADINE	LORATADINE	tablet, oral	59556-301ANDA
LORATADINE	LORATADINE	tablet, orally disintegrating, oral	59556-917ANDA
LOSARTAN POTASSIUM 100 mg	LOSARTAN POTASSIUM	tablet, film coated, oral	64380-935ANDA
LOSARTAN POTASSIUM 25 mg	LOSARTAN POTASSIUM	tablet, film coated, oral	64380-933ANDA
LOSARTAN POTASSIUM 50 mg	LOSARTAN POTASSIUM	tablet, film coated, oral	64380-934ANDA
Lamivudine	Lamivudine	tablet, film coated, oral	64380-710ANDA
Lamivudine	Lamivudine	tablet, film coated, oral	64380-711ANDA
Levonorgestrel Tablet, 1.5 mg	Levonorgestrel Tablet, 1.5 mg	tablet, oral	59556-282ANDA
Lidocaine	lidocaine	ointment, topical	64380-789ANDA
Loperamide Hydrochloride	Loperamide Hydrochloride	capsule, liquid filled, oral	59556-959ANDA
MYCOPHENOLATE MOFETIL	MYCOPHENOLATE MOFETIL	powder, for suspension, oral	64380-899ANDA
Megestrol Acetate	Megestrol Acetate	tablet, oral	64380-158ANDA
Megestrol Acetate	Megestrol Acetate	tablet, oral	64380-159ANDA
Megestrol Acetate	Megestrol Acetate	suspension, oral	64380-160ANDA
Methimazole	methimazole	tablet, oral	64380-212ANDA
Methimazole	methimazole	tablet, oral	64380-213ANDA
Methoxsalen	Methoxsalen	capsule, liquid filled, oral	64380-752ANDA
Minocycline Hydrochloride	Minocycline Hydrochloride	tablet, oral	64380-154ANDA
Minocycline Hydrochloride	Minocycline Hydrochloride	tablet, oral	64380-155ANDA
Minocycline Hydrochloride	Minocycline Hydrochloride	tablet, oral	64380-156ANDA
Mycophenolate mofetil	Mycophenolate mofetil	capsule, oral	42543-988ANDA
Mycophenolate mofetil	Mycophenolate mofetil	tablet, film coated, oral	42543-989ANDA
Mycophenolate mofetil	Mycophenolate mofetil	tablet, film coated, oral	64380-725ANDA
Mycophenolate mofetil	Mycophenolate mofetil	capsule, oral	64380-726ANDA
Nateglinide	nateglinide	tablet, oral	64380-167ANDA
Nateglinide	nateglinide	tablet, oral	64380-168ANDA
Olanzapine	olanzapine	tablet, orally disintegrating, oral	64380-172ANDA
Olanzapine	olanzapine	tablet, orally disintegrating, oral	64380-173ANDA
Olanzapine	olanzapine	tablet, orally disintegrating, oral	64380-174ANDA
Olanzapine	olanzapine	tablet, orally disintegrating, oral	64380-175ANDA
Omeprazole/Sodium Bicarbonate	omeprazole	powder, for suspension, oral	64380-182ANDA
Omeprazole/Sodium Bicarbonate	omeprazole	powder, for suspension, oral	64380-183ANDA
Optionelle	Levonorgestrel Tablet, 1.5 mg	tablet, oral	59556-286ANDA
Oseltamivir Phosphate	Oseltamivir Phosphate	capsule, oral	64380-797ANDA
Oseltamivir Phosphate	Oseltamivir Phosphate	capsule, oral	64380-798ANDA
Oseltamivir Phosphate	Oseltamivir Phosphate	capsule, oral	64380-799ANDA
Oseltamivir Phosphate	Oseltamivir Phosphate	powder, for suspension, oral	64380-879ANDA
Oxybutynin Chloride	oxybutynin chloride	tablet, oral	64380-162ANDA

Neighbours

Registered in the same town

Biocon Biologics LimitedBengaluru, IND · 5 sites
Micro Labs LimitedBengaluru, IND · 4 sites
Syngene International LimitedBengaluru, IND · 3 sites
CIPLA PHARMACEUTICALS LIMITEDBengaluru, IND · 2 sites
SHILPA MEDICARE LIMITEDBengaluru, 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
SOFTGEL HEALTHCARE PRIVATE LIMITEDChengalpattu, IND · 2 sites
Viatris Inc.Bengaluru, IND
Sun Pharmaceutical Industries LimitedChengalpattu, IND
Apotex Inc.Bengaluru, IND

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Enquiry

Common questions

Is Strides Pharma Science Limited FDA approved?: Strides Pharma Science Limited holds 5 FDA-registered establishments across 3 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 Strides Pharma Science Limited's drugs manufactured?: At registered sites in India, Italy, the United States. The FDA register lists Bengaluru; Chengalpattu; Puducherry; CUSANO MILANINO; Chestnut Ridge, NY. Registered operations: analytical testing, finished drug manufacture, packaging.
What drugs does Strides Pharma Science Limited make?: 230 products are listed under Strides Pharma Science Limited in the openFDA NDC Directory, most often as tablet; capsule; tablet, film coated. 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.