Register entry

Glenmark Pharmaceuticals Inc., USA

Data as of · How to read this entry

Registered sites
9
Active NDC listings
382
Labeller names
9
Live patents
17
Exclusivities
1
Countries
3
Base
India
Authorisation

Registered operations

Analytical testing8Active ingredient (API) manufacture3Labelling8Finished drug manufacture6Packaging6sterilize1
Sites

Registered establishments

9
EstablishmentAddressRegistered forFEI / DUNS
Glenmark Generics S.A.Registrant: Glenmark Pharmaceuticals Inc., USACalle 9 Ingeniero Meyer Oks 593 Parque Industrial Pilar,, Pilar, Buenos Aires 1629, Argentina (ARG)Analytical testing, Labelling, Finished drug manufacture, Packaging3009805225971451299
Alivus Life Sciences LimitedRegistrant: Glenmark Pharmaceuticals Inc., USAPlot No. 3109, GIDC Industrial Estate, District Bharuch, Ankleshwar, Gujarat 393002, India (IND)Analytical testing, Active ingredient (API) manufacture, Labelling3004006229650283737
Alivus Life Sciences LimitedRegistrant: Glenmark Pharmaceuticals Inc., USAPlot no Z-103-I SEZ Phase II Dahej, Taluka Vagra, Bharuch, Gujarat 392130, India (IND)Analytical testing, Active ingredient (API) manufacture, Labelling3007514214860186085
Glenmark Pharmaceuticals LimitedRegistrant: Glenmark Pharmaceuticals Inc., USAPlot No. B-25, MIDC, Shendra, Chhatrapati Sambhajinagar (previously known as Aurangabad), Maharashtra 431154, India (IND)Analytical testing, Labelling, Finished drug manufacture, Packaging3009915929650565703
Glenmark Pharmaceuticals LimitedRegistrant: Glenmark Pharmaceuticals Inc., USAPlot No. 2, Phase-2, Pharma Zone SEZ Pithampur, Dhar, Madhya Pradesh 454775, India (IND)Analytical testing, Labelling, Finished drug manufacture, Packaging3008565058862603186
Glenmark Pharmaceuticals LimitedRegistrant: Glenmark Pharmaceuticals Inc., USAPlot No S-7, Colvale Industrial Estate, Colvale-Bardez,, Goa, GA 403513, India (IND)Analytical testing, Labelling, Finished drug manufacture, Packaging3004672766677318665
Glenmark Pharmaceuticals LimitedRegistrant: Glenmark Pharmaceuticals Inc., USAVillage Kishanpura Baddi Nalagarh Road, Baddi, Solan, Himachal Pradesh 173205, India (IND)Analytical testing, Labelling, Finished drug manufacture, Packaging3005757050676115028
Alivus Life Sciences LimitedRegistrant: Glenmark Pharmaceuticals Inc., USAPlot No. 141-143, 160-165, 170-172, Chandramouli Sahakari Audyogik Vasahat Maryadit, Pune-Hyderabad Highway,, Mohol, Solapur, Maharashtra 413213, India (IND)Active ingredient (API) manufacture3014026060650513877
Glenmark Pharmaceuticals Inc., USA4147 Goldmine Rd, Monroe, North Carolina (NC) 28110, United States (USA)Analytical testing, Labelling, Finished drug manufacture, Packaging, sterilize3011585599079922908
Catalogue

Drug listings by form and route

382

382 active NDC listings: 364 human prescription drug, 18 human otc drug. By marketing category: ANDA 377, NDA AUTHORIZED GENERIC 4, NDA 1.

Dosage formNDCs
tablet, film coated89
tablet74
capsule36
injection, solution26
kit22
tablet, film coated, extended release16
capsule, extended release13
cream13
ointment13
gel9
injection, powder, lyophilized, for solution9
injection7
tablet, orally disintegrating6
capsule, delayed release5
injection, solution, concentrate4
RouteNDCs
oral253
topical42
intravenous39
intramuscular15
subcutaneous6
epidural5
infiltration5
ophthalmic5
nasal4
perineural3
sublingual3
vaginal3
auricular (otic)1
intraocular1
parenteral1
Labeller name on the listingNDCs
glenmark pharmaceuticals inc., usa280
glenmark pharmaceuticals inc., usa60
glenmark therapeutics inc., usa18
glenmark pharmaceuticals inc. usa8
glenmark pharmaceuticals inc.,usa8
glenmark pharmaceuticals inc3
glenmark therapeutics inc., usa3
glenmark pharmaceuticals limited1
glenmark pharmaceuticals, inc1
Exclusivity

Patents and exclusivities

17
PatentProductCoversExpiry
10016443RYALTRISmometasone furoate; olopatadine hydrochlorideuseSept 2034
10376526RYALTRISmometasone furoate; olopatadine hydrochlorideproductSept 2034
10517880RYALTRISmometasone furoate; olopatadine hydrochlorideproductSept 2034
10548907RYALTRISmometasone furoate; olopatadine hydrochlorideuseSept 2034
10561672RYALTRISmometasone furoate; olopatadine hydrochlorideproductSept 2034
10646500RYALTRISmometasone furoate; olopatadine hydrochlorideuseSept 2034
10758550RYALTRISmometasone furoate; olopatadine hydrochlorideuseSept 2034
10765686RYALTRISmometasone furoate; olopatadine hydrochlorideuseSept 2034
11400101RYALTRISmometasone furoate; olopatadine hydrochlorideuseSept 2034
12064442RYALTRISmometasone furoate; olopatadine hydrochlorideuseSept 2034
9078923RYALTRISmometasone furoate; olopatadine hydrochlorideproductSept 2034
9370483RYALTRISmometasone furoate; olopatadine hydrochlorideproductSept 2034
9750754RYALTRISmometasone furoate; olopatadine hydrochlorideproductSept 2034
9937189RYALTRISmometasone furoate; olopatadine hydrochlorideproductSept 2034
11679210RYALTRISmometasone furoate; olopatadine hydrochlorideproductSept 2038
12303635RYALTRISmometasone furoate; olopatadine hydrochloridesubstance, productApr 2039
12653833RYALTRISmometasone furoate; olopatadine hydrochlorideproductNov 2044
ProductExclusivityUntil
RYALTRISMOMETASONE FUROATE; OLOPATADINE HYDROCHLORIDENPP New patient populationJul 2029
Catalogue

Marketed products

383

Showing 150 of 383.

BrandGeneric nameForm / routeNDC
ALYACEN 1/35norethindrone and ethinyl estradiolkit68462-394ANDA
ALYACEN 7/7/7norethindrone and ethinyl estradiolkit68462-556ANDA
ASPRIN AND EXTENDED-RELEASE DIPYRIDAMOLEASPRIN AND EXTENDED-RELEASE DIPYRIDAMOLEcapsule, oral68462-405ANDA
Acamprosate CalciumAcamprosate Calciumtablet, delayed release, oral68462-435ANDA
Acetaminophen, IbuprofenAcetaminophen, Ibuprofentablet, film coated, oral72657-157ANDA
AcetylcysteineAcetylcysteineinjection, solution, intravenous68462-946ANDA
AdapaleneAdapalenegel, topical72657-158ANDA
Alclometasone DipropionateAlclometasone Dipropionateointment, topical68462-299ANDA
Amlodipine and Olmesartan MedoxomilAmlodipine and Olmesartan Medoxomiltablet, film coated, oral68462-566ANDA
Amlodipine and Olmesartan MedoxomilAmlodipine and Olmesartan Medoxomiltablet, film coated, oral68462-567ANDA
Amlodipine and Olmesartan MedoxomilAmlodipine and Olmesartan Medoxomiltablet, film coated, oral68462-568ANDA
Amlodipine and Olmesartan MedoxomilAmlodipine and Olmesartan Medoxomiltablet, film coated, oral68462-569ANDA
AprepitantAprepitantkit68462-112ANDA
AprepitantAprepitantcapsule, oral68462-583ANDA
AprepitantAprepitantcapsule, oral68462-584ANDA
AprepitantAprepitantcapsule, oral68462-585ANDA
AshlynaLevonorgestrel and Ethinyl Estradiol and Ethinyl Estradiolkit68462-646ANDA
Atovaquone and Proguanil HydrochlorideAtovaquone and Proguanil Hydrochloridetablet, film coated, oral68462-404ANDA
Atovaquone and Proguanil Hydrochloride PediatricAtovaquone and Proguanil Hydrochloride Pediatrictablet, film coated, oral68462-402ANDA
AzathioprineAzathioprinetablet, oral68462-502ANDA
BRIELLYNNorethindrone and Ethinyl Estradiolkit68462-316ANDA
Benazepril Hydrochloride and HydrochlorothiazideBenazepril Hydrochloride and Hydrochlorothiazidetablet, film coated, oral68462-576ANDA
Benazepril Hydrochloride and HydrochlorothiazideBenazepril Hydrochloride and Hydrochlorothiazidetablet, film coated, oral68462-577ANDA
Benazepril Hydrochloride and HydrochlorothiazideBenazepril Hydrochloride and Hydrochlorothiazidetablet, film coated, oral68462-578ANDA
Benazepril Hydrochloride and HydrochlorothiazideBenazepril Hydrochloride and Hydrochlorothiazidetablet, film coated, oral68462-579ANDA
Betamethasone DipropionateBetamethasone Dipropionatecream, topical68462-290ANDA
Bisoprolol Fumarate and HydrochlorothiazideBisoprolol Fumarate and Hydrochlorothiazidetablet, film coated, oral68462-878ANDA
Bisoprolol Fumarate and HydrochlorothiazideBisoprolol Fumarate and Hydrochlorothiazidetablet, film coated, oral68462-879ANDA
Bisoprolol Fumarate and HydrochlorothiazideBisoprolol Fumarate and Hydrochlorothiazidetablet, film coated, oral68462-880ANDA
Brimonidine Tartrate/Timolol MaleateBrimonidine Tartrate and Timolol Maleatesolution/ drops, ophthalmic68462-281ANDA
BumetanideBumetanideinjection, intramuscular, intravenous68462-469ANDA
BumetanideBumetanideinjection, intramuscular, intravenous68462-470ANDA
CLOBETASOL PROPIONATECLOBETASOL PROPIONATEspray, topical68462-480ANDA
CLOBETASOL PROPIONATECLOBETASOL PROPIONATEsolution, topical68462-532ANDA
CalcipotrieneCalcipotrieneointment, topical68462-310ANDA
Calcium GluconateCalcium Gluconateinjection, solution, intravenous68462-789ANDA
Calcium GluconateCalcium Gluconateinjection, solution, intravenous68462-790ANDA
Calcium GluconateCalcium Gluconateinjection, solution, intravenous68462-791ANDA
CarvedilolCarvediloltablet, film coated, oral68462-162ANDA
CarvedilolCarvediloltablet, film coated, oral68462-163ANDA
CarvedilolCarvediloltablet, film coated, oral68462-164ANDA
CarvedilolCarvediloltablet, film coated, oral68462-165ANDA
Cetirizine HClCetirizinetablet, oral72657-128ANDA
Cetirizine HClCetirizinetablet, oral72657-129ANDA
Cetirizine HClCetirizinekit72657-130ANDA
Cetirizine HClCetirizinekit72657-131ANDA
Charlotte 24Fenorethindrone acetate and ethinyl estradiol and ferrous fumaratekit68462-852ANDA
Childrens Fluticasone Propionate ALLERGY RELIEFfluticasone propionatespray, metered, nasal72657-166ANDA
Chlorpromazine HydrochlorideChlorpromazine Hydrochloridetablet, film coated, oral68462-861ANDA
Chlorpromazine HydrochlorideChlorpromazine Hydrochloridetablet, film coated, oral68462-862ANDA
Chlorpromazine HydrochlorideChlorpromazine Hydrochloridetablet, film coated, oral68462-863ANDA
Chlorpromazine HydrochlorideChlorpromazine Hydrochloridetablet, film coated, oral68462-864ANDA
Chlorpromazine HydrochlorideChlorpromazine Hydrochloridetablet, film coated, oral68462-865ANDA
Ciclopirox OlamineCiclopirox Olaminecream, topical68462-297ANDA
Citalopram HydrobromideCitalopram Hydrobromidetablet, film coated, oral72657-109ANDA
Citalopram HydrobromideCitalopram Hydrobromidetablet, film coated, oral72657-110ANDA
Citalopram HydrobromideCitalopram Hydrobromidetablet, film coated, oral72657-111ANDA
Clindamycin HydrochlorideClindamycin Hydrochloridecapsule, oral68462-142ANDA
Clindamycin HydrochlorideClindamycin Hydrochloridecapsule, oral68462-143ANDA
Clindamycin HydrochlorideClindamycin Hydrochloridecapsule, oral68462-144ANDA
Clindamycin PhosphateClindamycin Phosphateaerosol, foam, topical68462-605ANDA
Clindamycin PhosphateClindamycin Phosphategel, topical68462-866ANDA
Clobetasol PropionateClobetasol Propionateointment, topical68462-530ANDA
Clobetasol Propionateclobetasol propionateaerosol, foam, topical68462-608ANDA
ClotrimazoleClotrimazolecream, topical68462-181ANDA
Clotrimazole and Betamethasone DipropionateClotrimazole and Betamethasone Dipropionatecream, topical68462-298ANDA
Colesevelam HydrochlorideColesevelam Hydrochloridepowder, for suspension, oral68462-620ANDA
DICLOFENAC SODIUMdiclofenac sodiumgel, topical68462-355ANDA
DIMETHYL FUMARATEdimethyl-fumaratecapsule, oral68462-307ANDA
DIMETHYL FUMARATEdimethyl-fumaratecapsule, oral68462-308ANDA
DIMETHYL FUMARATEdimethyl fumarate kitkit68462-570ANDA
Desmopressin AcetateDesmopressin Acetatetablet, oral68462-275ANDA
Desmopressin AcetateDesmopressin Acetatetablet, oral68462-276ANDA
DesoximetasoneDesoximetasoneointment, topical68462-531ANDA
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine SulfateDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfatetablet, oral68462-647ANDA
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine SulfateDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfatetablet, oral68462-649ANDA
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine SulfateDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfatetablet, oral68462-651ANDA
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine SulfateDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfatetablet, oral68462-652ANDA
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine SulfateDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfatetablet, oral68462-653ANDA
Diltiazem HydrochlorideDiltiazem Hydrochloridecapsule, extended release, oral68462-562ANDA
Diltiazem HydrochlorideDiltiazem Hydrochloridecapsule, extended release, oral68462-850ANDA
Diltiazem HydrochlorideDiltiazem Hydrochloridecapsule, extended release, oral68462-851ANDA
ERIBULIN MESYLATEeribulin mesylateinjection, intravenous68462-770ANDA
ESTRADIOL VAGINAL INSERTSestradioltablet, film coated, vaginal68462-711ANDA
Esomeprazole MagnesiumEsomeprazole Magnesiumcapsule, delayed release pellets, oral68462-390ANDA
Esomeprazole MagnesiumEsomeprazole Magnesiumcapsule, delayed release pellets, oral68462-391ANDA
EszopicloneEszopiclonetablet, film coated, oral68462-382ANDA
EszopicloneEszopiclonetablet, film coated, oral68462-383ANDA
EszopicloneEszopiclonetablet, film coated, oral68462-384ANDA
EzetimibeEzetimibetablet, oral68462-226ANDA
FLUOCINOLONE ACETONIDEfluocinolone acetonideoil, topical68462-590ANDA
FLUTICASONE PROPIONATEfluticasone propionateaerosol, metered, respiratory (inhalation)68462-937ANDA
FamotidineFamotidinetablet, film coated, oral72657-112ANDA
FamotidineFamotidinetablet, film coated, oral72657-113ANDA
FamotidineFamotidinetablet, film coated, oral72657-132ANDA
FelodipineFelodipinetablet, film coated, extended release, oral68462-233ANDA
FelodipineFelodipinetablet, film coated, extended release, oral68462-234ANDA
FelodipineFelodipinetablet, film coated, extended release, oral68462-235ANDA
FluconazoleFluconazoletablet, oral68462-101ANDA
FluconazoleFluconazoletablet, oral68462-102ANDA
FluconazoleFluconazoletablet, oral68462-104ANDA
FluconazoleFluconazoletablet, oral68462-119ANDA
FluocinonideFluocinonidecream, topical68462-505ANDA
Fluphenazine HydrochlorideFluphenazine Hydrochloridetablet, film coated, oral68462-336ANDA
Fluphenazine HydrochlorideFluphenazine Hydrochloridetablet, film coated, oral68462-337ANDA
Fluphenazine HydrochlorideFluphenazine Hydrochloridetablet, film coated, oral68462-338ANDA
Fluphenazine HydrochlorideFluphenazine Hydrochloridetablet, film coated, oral68462-914ANDA
Fluticasone PropionateFluticasone Propionatelotion, topical68462-427ANDA
Fluticasone PropionateFluticasone Propionatespray, metered, nasal68462-918ANDA
Fluticasone Propionate ALLERGY RELIEFfluticasone propionatespray, metered, nasal72657-159ANDA
Fosphenytoin sodiumFosphenytoin sodiuminjection, solution, intramuscular, intravenous68462-621ANDA
Fosphenytoin sodiumFosphenytoin sodiuminjection, solution, intramuscular, intravenous68462-622ANDA
Fosphenytoin sodiumFosphenytoin sodiuminjection, solution, intramuscular, intravenous68462-945ANDA
FulvestrantFulvestrantinjection, intramuscular68462-317ANDA
GabapentinGabapentintablet, oral68462-126ANDA
GabapentinGabapentintablet, oral68462-127ANDA
HAILEY Fe 1/20norethindrone acetate and ethinyl estradiol and ferrous fumaratekit68462-419ANDA
HEATHERNorethindronetablet, oral68462-303ANDA
Hailey 1.5/30Norethindrone Acetate and Ethinyl Estradioltablet, oral68462-504ANDA
Hailey 24 Fenorethindrone acetate and ethinyl estradiol, and ferrous fumaratekit68462-731ANDA
Hailey Fe 1.5/30Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumaratekit68462-503ANDA
Hydralazine HydrochlorideHydralazine Hydrochloridetablet, oral68462-341ANDA
Hydralazine HydrochlorideHydralazine Hydrochloridetablet, oral68462-342ANDA
Hydralazine HydrochlorideHydralazine Hydrochloridetablet, oral68462-343ANDA
Hydralazine HydrochlorideHydralazine Hydrochloridetablet, oral68462-344ANDA
Hydrocortisone ValerateHYDROCORTISONE VALERATEointment, topical68462-836ANDA
ImiquimodImiquimodcream, topical68462-536ANDA
IndomethacinIndomethacincapsule, oral68462-302ANDA
IndomethacinIndomethacincapsule, oral68462-406ANDA
KETOROLAC TROMETHAMINEketorolac tromethamineinjection, solution, intramuscular, intravenous68462-755ANDA
KETOROLAC TROMETHAMINEketorolac tromethamineinjection, solution, intramuscular, intravenous68462-756ANDA
KETOROLAC TROMETHAMINEketorolac tromethamineinjection, solution, intramuscular68462-757ANDA
LACOSAMIDELACOSAMIDEinjection, solution, intravenous68462-697ANDA
LEVOCETIRIZINE DIHYDROCHLORIDElevocetirizine dihydrochloridetablet, oral68462-346ANDA
LacosamideLacosamidesolution, oral68462-940ANDA
LamotrigineLamotriginetablet, chewable, oral68462-228ANDA
LamotrigineLamotriginetablet, chewable, oral68462-229ANDA
Leucovorin CalciumLeucovorin Calciuminjection, powder, lyophilized, for solution, intramuscular, intravenous68462-767ANDA
LevonorgestrelLevonorgestreltablet, oral72657-123ANDA
Levonorgestrel and Ethinyl EstradiolLevonorgestrel and Ethinyl Estradioltablet, oral68462-637ANDA
Lithium CarbonateLithium Carbonatecapsule, oral68462-220ANDA
Lithium CarbonateLithium Carbonatecapsule, oral68462-221ANDA
Lithium CarbonateLithium Carbonatecapsule, oral68462-222ANDA
Lithium CarbonateLithium Carbonatetablet, film coated, extended release, oral68462-223ANDA
Lithium Carbonate ERLithium Carbonatetablet, oral68462-224ANDA
MARLISSALevonorgestrel and Ethinyl Estradiolkit68462-388ANDA
METFORMIN HYDROCHLORIDEmetformin hydrochloridetablet, film coated, extended release, oral68462-520ANDA
METFORMIN HYDROCHLORIDEmetformin hydrochloridetablet, film coated, extended release, oral68462-521ANDA
METHYLENE BLUEMETHYLENE BLUEinjection, intravenous68462-698ANDA
MICAFUNGINMicafungininjection, powder, lyophilized, for solution, intravenous68462-771ANDA
Neighbours

Registered in the same town

12
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Enquiry

Common questions

Is Glenmark Pharmaceuticals Inc., USA FDA approved?
Glenmark Pharmaceuticals Inc., USA holds 9 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 Glenmark Pharmaceuticals Inc., USA's drugs manufactured?
At registered sites in Argentina, India, the United States. The FDA register lists Pilar; Ankleshwar; Bharuch; Chhatrapati Sambhajinagar (previously known as Aurangabad); Dhar; Goa, and 3 more. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging, sterilize.
What drugs does Glenmark Pharmaceuticals Inc., USA make?
383 products are listed under Glenmark Pharmaceuticals Inc., USA in the openFDA NDC Directory, most often as tablet, film coated; tablet; 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.