Drug factory · FDA FEI 3012696190

InvaGen Pharmaceuticals, Inc

550 S Research Place, Central Islip, NY, United States

United States: 1

Problems found, fixed voluntarily at FDA's last inspection, Jul 17, 2026.

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

4 drug inspections on record since 2017: 0 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
AlfuzosinTests it and packages it Cipla USA., Inc., Exelan Pharmaceuticals, Inc. 69097-844, 76282-302
AmlodipineTests it and packages it Cipla USA., Inc., Exelan Pharmaceuticals, Inc. 69097-836, 69097-837, 69097-838 +6
BenztropineTests it and packages it Cipla USA., Inc. 69097-826, 69097-827, 69097-832
BupropionTests it and packages it Cipla USA., Inc., Exelan Pharmaceuticals, Inc. 69097-875, 69097-876, 69097-877 +6
Calcium CationTests it and packages it Cipla USA., Inc., Exelan Pharmaceuticals, Inc. 69097-862, 76282-377
CelecoxibMakes it, tests it and packages it Exelan Pharmaceuticals, Inc. 76282-692, 76282-693, 76282-694 +1
CitalopramTests it and packages it Cipla USA., Inc., Exelan Pharmaceuticals, Inc. 69097-822, 69097-823, 69097-824 +3
CyclobenzaprineMakes it, tests it and packages it Cipla USA., Inc., Exelan Pharmaceuticals, Inc. 69097-845, 69097-846, 76282-283
DarunavirMakes it, tests it and packages it Cipla USA., Inc., Exelan Pharmaceuticals, Inc. 69097-244, 69097-248, 76282-737 +1
EscitalopramTests it and packages it Cipla USA., Inc., Exelan Pharmaceuticals, Inc. 69097-847, 69097-848, 69097-849 +3
Fenofibric AcidTests it and packages it Cipla USA., Inc. 69097-894, 69097-895, 69097-896
FinasterideMakes it, tests it and packages it Exelan Pharmaceuticals, Inc. 76282-412
Fluticasone and SalmeterolMakes it Cipla USA., Inc. 69097-661, 69097-662, 69097-663
Folic AcidPackages it Exelan Pharmaceuticals, Inc. 76282-210
FosinoprilatTests it and packages it Cipla USA., Inc., Exelan Pharmaceuticals, Inc. 69097-856, 69097-857, 69097-858 +3
Fosinoprilat and HydrochlorothiazideTests it and packages it Cipla USA., Inc. 69097-972, 69097-973
GabapentinMakes it, tests it and packages it Cipla USA., Inc., Exelan Pharmaceuticals, Inc. 69097-811, 69097-812, 69097-813 +8
GemfibrozilTests it and packages it Cipla USA., Inc., Exelan Pharmaceuticals, Inc. 69097-821, 76282-225
HydralazineTests it and packages it Exelan Pharmaceuticals, Inc. 76282-309, 76282-310, 76282-311 +1
Hydrochlorothiazide and LisinoprilTests it and packages it Cipla USA., Inc., Exelan Pharmaceuticals, Inc. 69097-968, 69097-969, 69097-971 +3
Hydrochlorothiazide and QuinaprilatTests it and packages it Cipla USA., Inc. 69097-828, 69097-829, 69097-831
LevetiracetamTests it and packages it Exelan Pharmaceuticals, Inc. 76282-246, 76282-247, 76282-248
LidocaineSterilizes it Cipla USA., Inc., Exelan Pharmaceuticals, Inc. 69097-590, 76282-669
LisinoprilTests it and packages it Exelan Pharmaceuticals, Inc. 76282-417, 76282-418, 76282-419 +3
LurasidoneTests it and packages it Cipla USA., Inc., Exelan Pharmaceuticals, Inc. 69097-937, 69097-938, 69097-939 +7
MeprobamateTests it and packages it Cipla USA., Inc. 69097-974, 69097-975
NabumetoneMakes it, tests it and packages it Cipla USA., Inc., Exelan Pharmaceuticals, Inc. 69097-965, 69097-966, 76282-257 +1
NadololTests it and packages it BluePoint Laboratories., Cipla USA., Inc., Exelan Pharmaceuticals, Inc. 68001-317, 68001-318, 68001-319 +6
NaproxenTests it and packages it Cipla USA., Inc., Exelan Pharmaceuticals, Inc. 69097-851, 69097-852, 69097-853 +5
PregabalinPackages it Cipla USA., Inc., Exelan Pharmaceuticals, Inc. 69097-954, 69097-955, 69097-956 +13
QuinaprilatTests it and packages it Cipla USA., Inc. 69097-839, 69097-841, 69097-842 +1
RaloxifeneTests it and packages it Cipla USA., Inc., Exelan Pharmaceuticals, Inc. 69097-825, 76282-256
RamiprilatPackages it Exelan Pharmaceuticals, Inc. 76282-271, 76282-272, 76282-273 +1
RizatriptanTests it and packages it Cipla USA., Inc., Exelan Pharmaceuticals, Inc. 69097-865, 69097-866, 76282-462 +1
SertralineMakes it, tests it and packages it Cipla USA., Inc., Exelan Pharmaceuticals, Inc. 69097-833, 69097-834, 69097-835 +3
SevelamerTests it and packages it Cipla USA., Inc., Exelan Pharmaceuticals, Inc. 69097-893, 69097-967, 76282-407 +1
TerbinafineTests it and packages it Cipla USA., Inc., Exelan Pharmaceuticals, Inc. 69097-859, 76282-209
TicagrelorMakes it, tests it and packages it Cipla USA., Inc., Exelan Pharmaceuticals, Inc. 69097-989, 69097-991, 76282-550 +1
TopiramateMakes it, tests it and packages it Cipla USA., Inc., Exelan Pharmaceuticals, Inc. 69097-816, 69097-817, 69097-818 +5
TrospiumTests it and packages it Cipla USA., Inc., Exelan Pharmaceuticals, Inc. 69097-912, 76282-336
VigabatrinPackages it Cipla USA., Inc. 69097-964
VilazodoneTests it and packages it Cipla USA., Inc., Exelan Pharmaceuticals, Inc. 69097-979, 69097-982, 76282-544 +1
WarfarinTests it and packages it Exelan Pharmaceuticals, Inc. 76282-327, 76282-328, 76282-329 +6
ZolmitriptanTests it and packages it Cipla USA., Inc. 69097-863, 69097-864
ZonisamideMakes it, tests it and packages it Cipla USA., Inc., Exelan Pharmaceuticals, Inc. 69097-861, 76282-226, 76282-227 +1

FDA inspection history

EndedResultProgramProblems noted
Jul 17, 2026Problems found, fixed voluntarilyDrug Quality Assurance—
Sep 19, 2023Problems found, fixed voluntarilyDrug Quality Assurance—
Dec 19, 2018Problems found, fixed voluntarilyDrug Quality Assurance—
May 26, 2017Problems found, fixed voluntarilyDrug Quality Assurance—

Registered with FDA for: analysis; manufacture; pack; repack.