Drug factory · FDA FEI 3004819820

Lupin Limited

Plot No. 15-B, Phase 1-A, Verna Industrial Area, Verna, Salcette, India

India: 1

Problems found, fixed voluntarily at FDA's last inspection, Nov 21, 2025.

Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.

9 drug inspections on record since 2009: 2 with no problems, 6 with problems fixed voluntarily, 1 with FDA action.

What it does, for whom

DrugRoleForNDC
Abacavir and LamivudineMakes it and packages it Lupin Pharmaceuticals, Inc. 68180-288
AmlodipineMakes it and packages it Lupin Pharmaceuticals, Inc. 68180-750, 68180-751, 68180-752
Amlodipine and BenazeprilatMakes it and packages it BluePoint Laboratories., Lupin Pharmaceuticals, Inc. 68001-130, 68001-131, 68001-132 +13
Amlodipine and Hydrochlorothiazide and ValsartanMakes it and packages it Lupin Pharmaceuticals, Inc. 68180-771, 68180-772, 68180-773 +2
Amlodipine and TelmisartanMakes it Lupin Pharmaceuticals, Inc. 68180-196, 68180-197, 68180-198 +1
Amlodipine and ValsartanMakes it and packages it Lupin Pharmaceuticals, Inc. 68180-764, 68180-765, 68180-766 +1
AzithromycinMakes it and packages it Lupin Pharmaceuticals, Inc. 68180-861, 68180-862, 68180-863
BupropionMakes it and packages it Lupin Pharmaceuticals, Inc., Quallent Pharmaceuticals Health LLC 68180-319, 68180-320, 82009-051 +1
CelecoxibMakes it and packages it Lupin Pharmaceuticals, Inc. 68180-395, 68180-396, 68180-397 +1
ClarithromycinMakes it and packages it Lupin Pharmaceuticals, Inc. 68180-177
DesloratadineMakes it and packages it Lupin Pharmaceuticals, Inc. 68180-153
DesvenlafaxineMakes it and packages it Lupin Pharmaceuticals, Inc. 68180-592, 68180-593, 68180-604
DonepezilMakes it and packages it Lupin Pharmaceuticals, Inc. 68180-527
DoxycyclineMakes it and packages it Lupin Pharmaceuticals, Inc. 68180-650, 68180-651, 68180-652 +1
DuloxetineMakes it and packages it Lupin Pharmaceuticals, Inc. 68180-294, 68180-295, 68180-296 +1
Emtricitabine and TenofovirMakes it and packages it Lupin Pharmaceuticals, Inc. 68180-287
EscitalopramMakes it and packages it Lupin Pharmaceuticals, Inc. 68180-135, 68180-136, 68180-137
EslicarbazepineMakes it and packages it Lupin Pharmaceuticals, Inc. 68180-290, 68180-291, 68180-292 +1
EszopicloneMakes it and packages it Lupin Pharmaceuticals, Inc. 68180-322, 68180-323, 68180-324
EthambutolMakes it and packages it Lupin Pharmaceuticals, Inc. 68180-280, 68180-281
FamotidineMakes it and packages it Lupin Pharmaceuticals, Inc. 68180-150
Fenofibric AcidMakes it, tests it and packages it Dr.Reddy's Laboratories Ltd., Lupin Pharmaceuticals, Inc. 55111-349, 55111-395, 27437-107 +7
FesoterodineMakes it Lupin Pharmaceuticals, Inc. 68180-618, 68180-619
Hydrochlorothiazide and LisinoprilMakes it and packages it Lupin Pharmaceuticals, Inc. 68180-518, 68180-519, 68180-520
Hydrochlorothiazide and LosartanMakes it and packages it Lupin Pharmaceuticals, Inc. 68180-215, 68180-216, 68180-217
Hydrochlorothiazide and ValsartanMakes it and packages it Lupin Pharmaceuticals, Inc. 68180-101, 68180-102, 68180-103 +2
ImipramineMakes it and packages it Lupin Pharmaceuticals, Inc. 68180-311, 68180-312, 68180-313 +4
LamivudineMakes it and packages it Lupin Pharmaceuticals, Inc. 68180-602, 68180-603
LevetiracetamMakes it and packages it BluePoint Laboratories., Lupin Pharmaceuticals, Inc. 68001-113, 68001-114, 68180-112 +5
LevofloxacinMakes it Lupin Pharmaceuticals, Inc. 68180-240, 68180-241, 68180-242
LisinoprilMakes it and packages it International Laboratories, LLC, Lupin Pharmaceuticals, Inc., Quallent Pharmaceuticals Health LLC 54458-872, 54458-873, 54458-874 +15
LosartanMakes it and packages it Lupin Pharmaceuticals, Inc. 68180-210, 68180-211, 68180-212 +6
LovastatinMakes it and packages it BluePoint Laboratories., International Laboratories, LLC, Lupin Pharmaceuticals, Inc. 68001-314, 68001-315, 68001-316 +6
Mefenamic AcidMakes it and packages it Lupin Pharmaceuticals, Inc. 68180-185
MeloxicamMakes it and packages it Lupin Pharmaceuticals, Inc. 68180-501, 68180-502
MemantineMakes it and packages it Lupin Pharmaceuticals, Inc. 68180-229, 68180-230
MetforminMakes it and packages it Lupin Pharmaceuticals, Inc. 68180-336, 68180-337, 68180-338 +1
MinocyclineMakes it and packages it Lupin Pharmaceuticals, Inc. 68180-460
NabumetoneMakes it Lupin Pharmaceuticals, Inc. 68180-141, 68180-142
NiacinMakes it and packages it Lupin Pharmaceuticals, Inc. 68180-221, 68180-222, 68180-223
PrasugrelMakes it Lupin Pharmaceuticals, Inc. 68180-795, 68180-796
PravastatinMakes it and packages it Lupin Pharmaceuticals, Inc. 68180-485, 68180-486, 68180-487 +1
PrucaloprideMakes it and packages it Lupin Pharmaceuticals, Inc. 70748-389, 70748-390
QuetiapineMakes it and packages it BluePoint Laboratories., Lupin Pharmaceuticals, Inc., Quallent Pharmaceuticals Health LLC 68001-180, 68001-181, 68001-182 +13
QuinaprilatMakes it and packages it BluePoint Laboratories., Lupin Pharmaceuticals, Inc. 68001-186, 68001-187, 68001-188 +7
QuinineMakes it and packages it Lupin Pharmaceuticals, Inc. 68180-560
RamiprilatMakes it and packages it Lupin Pharmaceuticals, Inc. 68180-588, 68180-589, 68180-590 +1
RanolazineMakes it and packages it Lupin Pharmaceuticals, Inc. 68180-354, 68180-355
RufinamideMakes it and packages it Lupin Pharmaceuticals, Inc. 68180-802, 68180-803, 68180-804
SertralineMakes it and packages it Lupin Pharmaceuticals, Inc. 68180-351, 68180-352, 68180-353
SildenafilMakes it and packages it Lupin Pharmaceuticals, Inc. 68180-283
SimvastatinMakes it and packages it Lupin Pharmaceuticals, Inc. 68180-464, 68180-465, 68180-478 +4
TrandolaprilatMakes it and packages it Lupin Pharmaceuticals, Inc. 68180-566, 68180-567, 68180-568
Valproic AcidMakes it and packages it Lupin Pharmaceuticals, Inc. 68180-265, 68180-266, 68180-267
ValsartanMakes it and packages it Lupin Pharmaceuticals, Inc. 68180-276, 68180-277, 68180-278 +1
VigabatrinMakes it and packages it Lupin Pharmaceuticals, Inc. 68180-521
ZolpidemMakes it and packages it Lupin Pharmaceuticals, Inc. 68180-779, 68180-780

FDA inspection history

EndedResultProgramProblems noted
Nov 21, 2025Problems found, fixed voluntarilyDrug Quality Assurance—
Sep 18, 2021Problems found, fixed voluntarilyDrug Quality Assurance—
Feb 8, 2019Serious problems, FDA actionDrug Quality Assurance—
Mar 11, 2016Problems found, fixed voluntarilyDrug Quality Assurance—
Jul 17, 2015Problems found, fixed voluntarilyDrug Quality Assurance—
May 17, 2013No problems foundDrug Quality Assurance—
Sep 16, 2011No problems foundDrug Quality Assurance—
Feb 12, 2010Problems found, fixed voluntarilyDrug Quality Assurance—
Mar 4, 2009Problems found, fixed voluntarilyDrug Quality Assurance—

Registered with FDA for: manufacture; pack.