Register entry

Encube Ethicals Limited

Data as of · How to read this entry

Registered sites
5
Active NDC listings
77
Live patents
0
Countries
2
Base
India
Authorisation

Registered operations

Analytical testing4Labelling2Finished drug manufacture3Packaging2
Sites

Registered establishments

5
EstablishmentAddressRegistered forFEI / DUNS
Encube Ethicals LimitedPlot No. 113, Smart Industrial Park (SIP), Pithampur,, Indore, Madhya Pradesh 454774, India (IND)Analytical testing, Labelling, Finished drug manufacture, Packaging3030695079645080178
Encube Ethicals LimitedUnit 24, Steelmade Industrial Estate, Marol, Andheri East,, Mumbai, Maharashtra 400059, India (IND)Analytical testing3007532627915834105
Encube Ethicals LimitedPlot No C-1 Madkaim Industrial Estate, Ponda, 403404, India (IND)Analytical testing, Labelling, Finished drug manufacture, Packaging3005669319725076298
Encube Ethicals LimitedCS No. 59/5, 63/1, 64/1, 64/2,64/3, 64/4, 64/5, 242/5, 242/6, 266/1, 266/2, Village Hedutane, Kalyan,, Thane, Maharashtra 421204, India (IND)Analytical testing3037647985772679277
Encube Ethicals, Inc.Registrant: Encube Ethicals Inc.200 Meredith DR STE 202,, Durham, North Carolina (NC) 27713, United States (USA)Finished drug manufacture3015216825116982244
Catalogue

Drug listings by form and route

77

77 active NDC listings: 66 human prescription drug, 11 human otc drug. By marketing category: ANDA 68, OTC MONOGRAPH DRUG 9.

Dosage formNDCs
gel24
cream21
ointment17
solution9
lotion2
kit1
lotion, augmented1
shampoo1
suspension1
RouteNDCs
topical68
transdermal3
vaginal3
rectal2
Labeller name on the listingNDCs
encube ethicals, inc.77
Catalogue

Marketed products

77
BrandGeneric nameForm / routeNDC
ANTIFUNGALClotrimazolecream, topical21922-094OTC MONOGRAPH DRUG
Adapalene Gel USP, 0.3%Adapalene Gel USP, 0.3%gel, topical21922-051ANDA
Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%gel, topical21922-052ANDA
Antifungal CreamMiconazole Nitratecream, topical21922-095OTC MONOGRAPH DRUG
Azelaic Acid GelAzelaic Acidgel, topical21922-038ANDA
BACITRACIN ZINCfirst aid antibioticointment, topical21922-091OTC MONOGRAPH DRUG
Betamethasone DipropionateBETAMETHASONE DIPROPIONATElotion, augmented, topical21922-104ANDA
CICLOPIROXciclopiroxsolution, topical21922-053ANDA
CICLOPIROXciclopiroxshampoo, topical21922-105ANDA
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDECLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDEgel, topical21922-074ANDA
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDECLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDEgel, topical21922-022ANDA
CLOBETASOL PROPIONATEclobetasol propionatesolution, topical21922-061ANDA
Clindamycin Phoaphate Topical Solution USP, 1%Clindamycin Phosphate Topical Solution USP, 1%solution, topical21922-002ANDA
Clindamycin PhosphateClindamycin Phosphate Gel USP, 1%gel, topical21922-027ANDA
Clindamycin PhosphateClindamycin Phosphatelotion, topical21922-036ANDA
Clindamycin Phosphate and Tretinoin Gel 1.2%/0.025%Clindamycin Phosphate and Tretinoin Gel 1.2%/0.025%gel, topical21922-050ANDA
Clindamycin and Benzoyl PeroxideClindamycin and Benzoyl Peroxidekit21922-068ANDA
Clobetasol PropionateClobetasol Propionate Ointment USP, 0.05%ointment, topical21922-017ANDA
Clobetasol Propionate Cream USP, 0.05% Clobetasol Propionate Cream USP, 0.05%Clobetasol Propionate Cream USP, 0.05%cream, topical21922-016ANDA
DICLOFENAC SODIUMDICLOFENACsolution, topical21922-033ANDA
DICLOFENAC SODIUMdiclofenac sodium topical gel, 1%gel, topical21922-044ANDA
DapsoneDapsone Gel, 5%gel, topical21922-018ANDA
Desonide Ointment, 0.05%Desonide Ointment, 0.05%ointment, topical21922-004ANDA
DocosanolDocosanolcream, topical21922-023ANDA
Double Antibioticbacitracin zinc polymyxin b sulfateointment, topical21922-092OTC MONOGRAPH DRUG
ESTRADIOLEstradiolgel, transdermal21922-015ANDA
ESTRADIOL VAGINALEstradiolcream, vaginal21922-085ANDA
Econazole NitrateEconazole Nitratecream, topical21922-111ANDA
Estradiol GelEstradiolgel, topical21922-086ANDA
Estradiol GelEstradiolgel, topical21922-087ANDA
Estradiol GelEstradiolgel, topical21922-088ANDA
Estradiol GelEstradiolgel, topical21922-089ANDA
Estradiol GelEstradiolgel, topical21922-090ANDA
FLUOCINONIDEFluocinonidecream, topical21922-064ANDA
FLUOROURACILFluorouracilcream, topical21922-049ANDA
Fluocinolone Acetonide Topical Solution USP, 0.01%Fluocinolone Acetonide Topical Solution USP, 0.01%solution, topical21922-003ANDA
Fluocinonidefluocinonide topical solution usp, 0.05%solution, topical21922-001ANDA
FluorouracilFluorouracilsolution, topical21922-041ANDA
Fluticasone PropionateFluticasone Propionatecream, topical21922-075ANDA
HYDROCORTISONEHydrocortisonecream, topical21922-096OTC MONOGRAPH DRUG
Halobetasol PropionateHalobetasol Propionateointment, topical21922-108ANDA
HydrocortisoneHydrocortisonecream, topical21922-065ANDA
HydrocortisoneHydrocortisone 1%ointment, topical21922-098OTC MONOGRAPH DRUG
Hydrocortisone with aloeHydrocortisonecream, topical21922-097OTC MONOGRAPH DRUG
KetoconazoleKetoconazole Cream, 2%cream, topical21922-025ANDA
LIDOCAINE AND PRILOCAINE LIDOCAINE AND PRILOCAINELIDOCAINE AND PRILOCAINEcream, topical21922-076ANDA
LidocaineLidicaineointment, topical21922-107ANDA
METRONIDAZOLEMetronidazole Topicalgel, topical21922-070ANDA
MOMETASONE FUROATEMOMETASONE FUROATElotion, topical21922-072ANDA
MUPIROCINMUPIROCINointment, topical21922-073ANDA
MesalamineMesalaminesuspension, rectal21922-045ANDA
Metronidazole Vaginal GelMetronidazole vaginal gel, 1.3 %gel, vaginal21922-046ANDA
Metronidazole Vaginal Gel, 0.75%Metronidazolegel, vaginal21922-039ANDA
Mometasone furoateMometasone furoateointment, topical21922-071ANDA
MupirocinMupirocincream, topical21922-029ANDA
NITROGLYCERINNitroglycerinointment, rectal21922-048ANDA
NITROGLYCERINNitroglycerinointment, topical21922-054ANDA
Nystatin and Triamcinolone AcetonideNystatin and Triamcinolone Acetonideointment, topical21922-031ANDA
PermethrinPermethrin Cream 5% w/wcream, topical21922-021ANDA
TESTOSTERONEtestosteronegel, transdermal21922-030ANDA
TRETINOINTretinoingel, topical21922-042ANDA
TRETINOINTretinoingel, topical21922-043ANDA
TRETINOINTretinoingel, topical21922-056ANDA
TRETINOINTretinoingel, topical21922-057ANDA
TRIAMCINOLONE ACETONIDEtriamcinolone acetonidecream, topical21922-062ANDA
TRIAMCINOLONE ACETONIDETriamcinolone Acetonideointment, topical21922-063ANDA
TRIPLE ANTIBIOTICbacitracin zinc neomycin sulfate polymyxin b sulfateointment, topical21922-093OTC MONOGRAPH DRUG
TRIPLE ANTIBIOTICBacitracin zinc Neomycin sulfate Polymyxin B sulfate Pramoxine Hclointment, topical21922-101OTC MONOGRAPH DRUG
TacrolimusTacrolimus Ointment 0.1%ointment, topical21922-011ANDA
TavaboroleTAVABOROLE topical solution, 5%solution, topical21922-020ANDA
TestosteroneTestosteronesolution, topical21922-109ANDA
Testosterone Gel, 1%Testosterone Gel, 1%gel, transdermal21922-019ANDA
TretinoinTretinoincream, topical21922-077ANDA
TretinoinTretinoincream, topical21922-078ANDA
TretinoinTretinoincream, topical21922-079ANDA
Triamcinolone AcetonideTriamcinolone Acetonide Ointment USP, 0.05%ointment, topical21922-024ANDA
hydrocortisone valerate creamhydrocortisone valerate creamcream, topical21922-007ANDA
Neighbours

Registered in the same town

12
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Enquiry

Common questions

Is Encube Ethicals Limited FDA approved?
Encube Ethicals Limited holds 5 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 Encube Ethicals Limited's drugs manufactured?
At registered sites in India, the United States. The FDA register lists Indore; Mumbai; Ponda; Thane; Durham, NC. Registered operations: analytical testing, labelling, finished drug manufacture, packaging.
What drugs does Encube Ethicals Limited make?
77 products are listed under Encube Ethicals Limited in the openFDA NDC Directory, most often as gel; cream; ointment. 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.