Register entryShortage reported

Lupin Limited

Data as of · How to read this entry

Registered sites
14
Active NDC listings
505
Labeller names
4
Live patents
12
Shortage listings
7
Countries
1
Base
India
Authorisation

Registered operations

Analytical testing1Active ingredient (API) manufacture7Finished drug manufacture9Packaging14
Sites

Registered establishments

14
EstablishmentAddressRegistered forFEI / DUNS
LUPIN MANUFACTURING SOLUTIONS LIMITEDPlot No.130, Road No. 11, J.N. Pharma City, Parawada (M), Anakapalli District, Andhra Pradesh 531019, India (IND)Active ingredient (API) manufacture, Packaging3013127166651038106
LUPIN LIMITEDPlot no. 09, 123, 123/1, 124 & 125 G.I.D.C. Industrial Estate, Ankleshwar, Gujarat 393002, India (IND)Active ingredient (API) manufacture, Packaging3002807510919137385
LUPIN LIMITEDA 28-1, MIDC Industrial Area, Chikalthana, Chhatrapati Sambhajinagar, Maharashtra 431210, India (IND)Finished drug manufacture, Packaging3004995645862272739
LUPIN LIMITEDUnit-1, Plot No. M-2 and M-2-A, Special Economic Zone, Phase II, MISC Zone Apparel Park, Pithampur, Dhar, Madhya Pradesh 454775, India (IND)Active ingredient (API) manufacture, Finished drug manufacture, Packaging3009831799650582310
LUPIN LIMITEDUnit-1, 198-202, New Industrial Area No. 2, Dist. Raisen, Mandideep, Madhya Pradesh 462046, India (IND)Active ingredient (API) manufacture, Finished drug manufacture, Packaging3002807511725504448
LUPIN LIMITEDUnit-2, 198-202, New Industrial Area No. 2, Dist. Raisen, Mandideep, Madhya Pradesh 462046, India (IND)Active ingredient (API) manufacture, Packaging3007756473677604666
LUPIN LIMITEDUnit-1, Plot No. 6A1, 6A2, Sector - 17, Special Economic Zone, Mihan, Nagpur, Maharashtra 441108, India (IND)Finished drug manufacture, Packaging3009843207650759348
LUPIN LIMITEDUnit-2, Plot No. 6B, Sector - 17, Special Economic Zone, Mihan, Nagpur, Maharashtra 441108, India (IND)Finished drug manufacture, Packaging3015392060675485014
LUPIN LIMITEDUnit-2, Plot No. M-2 and M-2-A, Special Economic Zone Phase II, Misc. Zone, Apparel Park, Dist. Dhar, Pithampur, Madhya Pradesh 454775, India (IND)Finished drug manufacture, Packaging3007549629863645527
LUPIN LIMITEDUnit-3, Plot No. M-1 and M-3-A, Special Economic Zone, Phase - II, Misc. Zone, Apparel Park, Dist. Dhar, Pithampur, Madhya Pradesh 454775, India (IND)Finished drug manufacture, Packaging3009107538650595213
Lupin LimitedGat No 1156, 1157, 1158, 1159 & 1160, Village Ghotawade Taluka - Mulshi, Pune, Maharashtra 412115, India (IND)Analytical testing, Finished drug manufacture, Packaging3010977634915787052
LUPIN LIMITEDPlot No. 15-B, Phase 1-A, Verna Industrial Area, Verna, Salcette, Goa 403722, India (IND)Finished drug manufacture, Packaging3004819820677600414
LUPIN LIMITEDT/142, MIDC Tarapur, Via Boisar, Palghar, Tarapur, Maharashtra 401506, India (IND)Active ingredient (API) manufacture, Packaging3002807512917063646
LUPIN MANUFACTURING SOLUTIONS LIMITEDBlock - 21, At & Post, Dabhasa, Taluka Padra, Vadodara, Gujarat 391440, India (IND)Active ingredient (API) manufacture, Packaging3005906909863842112
Alert

Drug shortage listings

7
DrugPresentationStatusAvailabilityPosted / updated
Quinapril Hydrochloride TabletCardiovascularQuinapril Hydrochloride, Tablet, 10 mg (NDC 68180-557-09)CurrentUnavailable19 Jan 20231 Sept 2026
Quinapril Hydrochloride TabletCardiovascularQuinapril Hydrochloride, Tablet, 20 mg (NDC 68180-558-09)CurrentUnavailable19 Jan 20231 Sept 2026
Quinapril Hydrochloride TabletCardiovascularQuinapril Hydrochloride, Tablet, 40 mg (NDC 68180-554-09)CurrentUnavailable19 Jan 20231 Sept 2026
Quinapril Hydrochloride TabletCardiovascularQuinapril Hydrochloride, Tablet, 5 mg (NDC 68180-556-09)CurrentUnavailable19 Jan 20231 Sept 2026
Rifampin CapsuleAnti-InfectiveRifampin, Capsule, 300 mg (NDC 68180-659-07)CurrentAvailable22 Dec 20211 Sept 2026
Rifampin CapsuleAnti-InfectiveRifampin, Capsule, 150 mg (NDC 68180-658-06)CurrentAvailable22 Dec 20211 Sept 2026
Rifampin CapsuleAnti-InfectiveRifampin, Capsule, 300 mg (NDC 68180-659-06)CurrentAvailable22 Dec 20211 Sept 2026
Catalogue

Drug listings by form and route

505

505 active NDC listings: 489 human prescription drug, 13 bulk ingredient, 3 human otc drug. By marketing category: ANDA 481, BULK INGREDIENT 13, NDA 6, NDA AUTHORIZED GENERIC 4, BLA 1.

Dosage formNDCs
tablet168
tablet, film coated64
capsule63
kit35
tablet, extended release31
tablet, film coated, extended release20
solution18
powder, for suspension13
powder12
capsule, extended release8
capsule, delayed release6
tablet, chewable6
cream5
for suspension5
suspension5
RouteNDCs
oral410
topical18
ophthalmic8
intravenous6
respiratory (inhalation)6
nasal3
subcutaneous3
rectal2
sublingual2
intramuscular1
transdermal1
Labeller name on the listingNDCs
lupin pharmaceuticals, inc.403
lupin pharmaceuticals,inc.89
lupin limited9
lupin manufacturing solutions limited4
Exclusivity

Patents and exclusivities

12
PatentProductCoversExpiry
9233112SUPRAXcefiximeproductDec 2028
7635773SESQUIENTfosphenytoin sodiumproductMar 2029
8410077SESQUIENTfosphenytoin sodiumproductMar 2029
9200088SESQUIENTfosphenytoin sodiumproductMar 2029
9750822SESQUIENTfosphenytoin sodiumproductMar 2029
9493582SESQUIENTfosphenytoin sodiumproductFeb 2033
9314447ANTARA (MICRONIZED)fenofibrateproductMay 2033
Catalogue

Marketed products

506

Showing 150 of 506.

BrandGeneric nameForm / routeNDC
ABACAVIR, LAMIVUDINE AND ZIDOVUDINEABACAVIR , LAMIVUDINE AND ZIDOVUDINEtablet, oral68180-286ANDA
AMLODIPINE AND VALSARTANamlodipine and valsartantablet, oral43386-080ANDA
AMLODIPINE AND VALSARTANamlodipine and valsartantablet, oral43386-081ANDA
AMLODIPINE AND VALSARTANamlodipine and valsartantablet, oral43386-082ANDA
AMLODIPINE AND VALSARTANAmlodipine and Valsartantablet, oral43386-083ANDA
ANTARAFENOFIBRATEcapsule, oral27437-109NDA
ANTARAFENOFIBRATEcapsule, oral27437-110NDA
ARMLUPEGpegfilgrastim-unneinjection, subcutaneous70748-273BLA
ATOVAQUONEATOVAQUONEsuspension, oral70748-299ANDA
Abacavir and LamivudineAbacavir and Lamivudinetablet, film coated, oral68180-288ANDA
Albuterol sulfateAlbuterol sulfateaerosol, metered, respiratory (inhalation)68180-963ANDA
Amlodipine BesylateAmlodipine Besylatetablet, oral68180-233ANDA
Amlodipine BesylateAmlodipine Besylatetablet, oral68180-455ANDA
Amlodipine BesylateAmlodipine Besylatetablet, oral68180-721ANDA
Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril Hydrochloridecapsule, oral68180-459ANDA
Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril Hydrochloridecapsule, oral68180-463ANDA
Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril Hydrochloridecapsule, oral68180-472ANDA
Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril Hydrochloridecapsule, oral68180-473ANDA
Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril Hydrochloridecapsule, oral68180-755ANDA
Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril Hydrochloridecapsule, oral68180-756ANDA
Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril Hydrochloridecapsule, oral68180-757ANDA
Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril Hydrochloridecapsule, oral68180-758ANDA
Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril Hydrochloridecapsule, oral68180-759ANDA
Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril Hydrochloridecapsule, oral68180-760ANDA
Amlodipine and ValsartanAmlodipine and Valsartantablet, oral68180-764ANDA
Amlodipine and ValsartanAmlodipine and Valsartantablet, oral68180-765ANDA
Amlodipine and ValsartanAmlodipine and Valsartantablet, oral68180-766ANDA
Amlodipine and ValsartanAmlodipine and Valsartantablet, oral68180-767ANDA
Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and Hydrochlorothiazidetablet, film coated, oral68180-771ANDA
Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and Hydrochlorothiazidetablet, film coated, oral68180-772ANDA
Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and Hydrochlorothiazidetablet, film coated, oral68180-773ANDA
Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and Hydrochlorothiazidetablet, film coated, oral68180-774ANDA
Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and Hydrochlorothiazidetablet, film coated, oral68180-775ANDA
Antarafenofibratecapsule, oral27437-107NDA
Antarafenofibratecapsule, oral27437-108NDA
Arformoterol tartrateArformoterol tartratesolution, respiratory (inhalation)70748-175ANDA
Atorvastatin CalciumAtorvastatin Calciumtablet, oral68180-635ANDA
Atorvastatin CalciumAtorvastatin Calciumtablet, oral68180-636ANDA
Atorvastatin CalciumAtorvastatin Calciumtablet, oral68180-637ANDA
Atorvastatin CalciumAtorvastatin Calciumtablet, oral68180-638ANDA
Azilsartan medoxomilAzilsartan medoxomiltablet, oral70748-236ANDA
Azilsartan medoxomilAzilsartan medoxomiltablet, oral70748-237ANDA
BLISOVI FE 1.5/30norethindrone acetate and ethinyl estradiolkit68180-866ANDA
BLISOVI FE 1.5/30norethindrone acetate and ethinyl estradiolkit68180-869ANDA
BRIVARACETAMbrivaracetamsolution, oral70748-411ANDA
BROMFENACBROMFENACsolution/ drops, ophthalmic68180-434ANDA
BUMETANIDEBumetanideinjection, intramuscular, intravenous70748-323ANDA
Betamethasone dipropionateBetamethasone dipropionateointment, augmented, topical68180-947ANDA
Blisovi 24 Fenorethindrone acetate and ethinyl estradiolkit68180-864ANDA
Blisovi Fe 1/20norethindrone acetate and ethinyl estradiolkit68180-865ANDA
BosentanBosentantablet, for suspension, oral68180-340ANDA
BromfenacBromfenacsolution, ophthalmic68180-436ANDA
Bupropion Hydrochloride XLBupropion Hydrochloridetablet, extended release, oral68180-319ANDA
Bupropion Hydrochloride XLBupropion Hydrochloridetablet, extended release, oral68180-320ANDA
CEFIXIMECEFIXIMEpowder, for suspension, oral68180-405ANDA
CEFIXIMECEFIXIMEpowder, for suspension, oral68180-407ANDA
CEFIXIMECEFIXIMEcapsule, oral68180-423NDA AUTHORIZED GENERIC
CEFPROZILcefprozilpowder, for suspension, oral68180-273ANDA
CEFPROZILCEFPROZILpowder, for suspension, oral68180-401ANDA
CEFPROZILCEFPROZILpowder, for suspension, oral68180-402ANDA
CEFPROZILCEFPROZILtablet, oral68180-403ANDA
CEFPROZILCEFPROZILtablet, oral68180-404ANDA
CYCLOSPORINEcyclosporineemulsion, ophthalmic68180-214NDA AUTHORIZED GENERIC
CarbidopaCarbidopatablet, oral43386-980ANDA
CefadroxilCefadroxilcapsule, oral68180-180ANDA
CefadroxilCefadroxilpowder, for suspension, oral68180-181ANDA
CefadroxilCefadroxilpowder, for suspension, oral68180-182ANDA
CefdinirCefdinircapsule, oral68180-711ANDA
CefdinirCefdinirpowder, for suspension, oral68180-722ANDA
CefdinirCefdinirpowder, for suspension, oral68180-723ANDA
-Cefdinir Monohydratepowder57297-700BULK INGREDIENT
-Cefprozilpowder57297-400BULK INGREDIENT
CephalexinCephalexincapsule, oral68180-121ANDA
CephalexinCephalexincapsule, oral68180-122ANDA
ClobazamClobazamtablet, oral68180-157ANDA
ClobazamClobazamtablet, oral68180-158ANDA
Clobetasol PropionateClobetasol Propionatelotion, topical68180-536ANDA
Clobetasol PropionateClobetasol Propionatecream, topical68180-956ANDA
Clomipramine HydrochlorideClomipramine Hydrochloride Capsulescapsule, oral68180-492ANDA
Clomipramine HydrochlorideClomipramine Hydrochloride Capsulescapsule, oral68180-493ANDA
Clomipramine HydrochlorideClomipramine Hydrochloride Capsulescapsule, oral68180-494ANDA
Clonidine HydrochlorideClonidine Hydrochloridetablet, extended release, oral68180-606ANDA
CyanocobalaminCyanocobalaminspray, metered, nasal43386-237ANDA
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEDAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEtablet, extended release, oral70748-101ANDA
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEDAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEtablet, extended release, oral70748-102ANDA
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEDAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEtablet, extended release, oral70748-103ANDA
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEDAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEtablet, extended release, oral70748-104ANDA
DARUNAVIRDARUNAVIRtablet, film coated, oral68180-345ANDA
DARUNAVIRDARUNAVIRtablet, film coated, oral68180-346ANDA
DESLORATADINEDESLORATADINEtablet, film coated, oral68180-153ANDA
DESOXIMETASONEDESOXIMETASONEointment, topical68180-946ANDA
DICLOFENAC SODIUMDICLOFENAC SODIUMsolution, topical43386-016ANDA
DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDEtablet, oral68180-527ANDA
DOXORUBICIN HYDROCHLORIDEDOXORUBICIN HYDROCHLORIDEinjection, suspension, liposomal, intravenous70748-339ANDA
DOXORUBICIN HYDROCHLORIDEDOXORUBICIN HYDROCHLORIDEinjection, suspension, liposomal, intravenous70748-340ANDA
DOXYCYCLINEDOXYCYCLINEcapsule, oral68180-650ANDA
DOXYCYCLINEDOXYCYCLINEcapsule, oral68180-652ANDA
DOXYCYCLINEDOXYCYCLINEfor suspension, oral68180-657ANDA
DOXYCYCLINEdoxycyclinecapsule, oral70748-308ANDA
DOXYCYCLINEdoxycyclineinjection, powder, lyophilized, for solution, intravenous70748-338ANDA
DROSPIRENONE AND ETHINYL ESTRADIOLDROSPIRENONE AND ETHINYL ESTRADIOLkit68180-868ANDA
DROXIDOPADROXIDOPAcapsule, oral68180-987ANDA
DROXIDOPADROXIDOPAcapsule, oral68180-988ANDA
DROXIDOPADROXIDOPAcapsule, oral68180-989ANDA
DapagliflozinDapagliflozintablet, oral70748-105ANDA
DapagliflozinDapagliflozintablet, oral70748-106ANDA
DasatinibDasatinibtablet, oral70748-208ANDA
DasatinibDasatinibtablet, oral70748-209ANDA
DasatinibDasatinibtablet, oral70748-210ANDA
DasatinibDasatinibtablet, oral70748-211ANDA
DasatinibDasatinibtablet, oral70748-212ANDA
DasatinibDasatinibtablet, oral70748-213ANDA
DayseeLEVONORGESTREL AND ETHINYL ESTRADIOLkit68180-846ANDA
DesoximetasoneDesoximetasonespray, topical68180-944ANDA
DesoximetasoneDesoximetasoneointment, topical68180-948ANDA
DesoximetasoneDesoximetasonecream, topical68180-949ANDA
DesoximetasoneDesoximetasonecream, topical68180-950ANDA
Desvenlafaxine SuccinateDesvenlafaxine Succinatetablet, film coated, extended release, oral68180-592ANDA
Desvenlafaxine SuccinateDesvenlafaxine Succinatetablet, film coated, extended release, oral68180-593ANDA
Desvenlafaxine SuccinateDesvenlafaxine Succinatetablet, film coated, extended release, oral68180-604ANDA
-Deutetrabenazinepowder83786-011BULK INGREDIENT
Dexmethylphenidate HydrochlorideDexmethylphenidate Hydrochloridetablet, oral43386-860ANDA
Dexmethylphenidate HydrochlorideDexmethylphenidate Hydrochloridetablet, oral43386-861ANDA
Dexmethylphenidate HydrochlorideDexmethylphenidate Hydrochloridetablet, oral43386-862ANDA
Dextroamphetamine Sulfatedextroamphetamine sulfatetablet, oral43386-870ANDA
Dextroamphetamine Sulfatedextroamphetamine sulfatetablet, oral43386-871ANDA
DiazepamDiazepamgel, rectal43386-280ANDA
DiazepamDiazepamgel, rectal43386-281ANDA
Diclofenac SodiumDiclofenac Sodiumsolution, topical68180-537ANDA
Divalproex SodiumDivalproex Sodiumtablet, delayed release, oral68180-265ANDA
Divalproex SodiumDivalproex Sodiumtablet, delayed release, oral68180-266ANDA
Divalproex SodiumDivalproex Sodiumtablet, delayed release, oral68180-267ANDA
Divalproex sodiumDivalproex sodiumtablet, extended release, oral68180-260ANDA
Divalproex sodiumDivalproex sodiumtablet, extended release, oral68180-261ANDA
Doxycyclinedoxycyclinecapsule, oral43386-790ANDA
Doxycyclinedoxycyclinecapsule, oral43386-791ANDA
Doxycyclinedoxycyclinecapsule, oral43386-792ANDA
Doxycycline HyclateDoxycycline Hyclatetablet, oral43386-794ANDA
DuloxetineDuloxetinecapsule, delayed release, oral68180-294ANDA
DuloxetineDuloxetinecapsule, delayed release, oral68180-295ANDA
DuloxetineDuloxetinecapsule, delayed release, oral68180-296ANDA
DuloxetineDuloxetinecapsule, delayed release, oral68180-297ANDA
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEEMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEtablet, film coated, oral68180-287ANDA
ENSKYCEdesogestrel and ethinyl estradiolkit68180-739ANDA
EscitalopramEscitslopramtablet, oral68180-137ANDA
Eslicarbazepine AcetateEslicarbazepine Acetatetablet, oral68180-290ANDA
Eslicarbazepine AcetateEslicarbazepine Acetatetablet, oral68180-291ANDA
Eslicarbazepine AcetateEslicarbazepine Acetatetablet, oral68180-292ANDA
Eslicarbazepine AcetateEslicarbazepine Acetatetablet, oral68180-293ANDA
-Eslicarbazepine Acetatepowder83786-010BULK INGREDIENT
Neighbours

Registered in the same town

12
Compare

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Enquiry

Common questions

Is Lupin Limited FDA approved?
Lupin Limited holds 14 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 Lupin Limited's drugs manufactured?
The FDA register lists Anakapalli District; Ankleshwar; Chhatrapati Sambhajinagar; Dhar; Mandideep; Nagpur, and 5 more. Registered operations: analytical testing, active ingredient (API) manufacture, finished drug manufacture, packaging.
What drugs does Lupin Limited make?
506 products are listed under Lupin 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.
Are any Lupin Limited products in shortage?
7 presentations are currently listed in the FDA drug shortage database under Lupin Limited, covering Quinapril Hydrochloride Tablet, Rifampin Capsule.

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.