Drug factory · FDA FEI 3012541241

Novitium Pharma LLC

70 Lake Drive, East Windsor, NJ, United States

United States: 1

No problems found at FDA's last inspection, Feb 16, 2024.

No Action Indicated: inspectors found no objectionable conditions.

5 drug inspections on record since 2018: 4 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
AcetazolamideMakes it, tests it, packages it and labels it ANI Pharmaceuticals, Inc. 70954-033, 70954-034
AcyclovirMakes it, tests it, packages it and labels it ANI Pharmaceuticals, Inc. 70954-188
Alendronic AcidMakes it, tests it, packages it and labels it ANI Pharmaceuticals, Inc. 70954-264
AlprazolamMakes it, tests it, packages it and labels it ANI Pharmaceuticals, Inc. 70954-508, 70954-509, 70954-510 +1
Atenolol and ChlorthalidoneMakes it, tests it, packages it and labels it ANI Pharmaceuticals, Inc. 70954-390, 70954-391
Bicarbonate Ion and OmeprazoleMakes it, tests it, packages it and labels it ANI Pharmaceuticals, Inc. 70954-797, 70954-798
BisoprololMakes it and packages it Novitium Pharma LLC 70954-455, 70954-456
Bisoprolol and HydrochlorothiazideMakes it, tests it, packages it and labels it ANI Pharmaceuticals, Inc. 70954-412, 70954-413, 70954-414
CarbamazepineMakes it, tests it, packages it and labels it ANI Pharmaceuticals, Inc. 70954-240
ChlorzoxazoneMakes it and packages it Cameron Pharmaceuticals, Novitium Pharma LLC 42494-426, 42494-427, 70954-085
ClomipheneMakes it, tests it, packages it and labels it ANI Pharmaceuticals, Inc. 70954-825
Clorazepic AcidMakes it, tests it, packages it and labels it ANI Pharmaceuticals, Inc. 70954-157, 70954-158, 70954-159
ClotrimazoleMakes it and labels it Novitium Pharma LLC 70954-036
DapsoneMakes it, tests it, packages it and labels it ANI Pharmaceuticals, Inc. 70954-135, 70954-136
DexamethasoneMakes it, tests it, packages it and labels it ANI Pharmaceuticals, Inc. 70954-398, 70954-399, 70954-401 +3
DicyclomineMakes it and packages it Novitium Pharma LLC 70954-261
DigoxinMakes it, tests it, packages it and labels it ANI Pharmaceuticals, Inc. 70954-200, 70954-201, 70954-202
EnalaprilatMakes it Bionpharma Inc. 69452-237
EstazolamMakes it and packages it Novitium Pharma LLC 70954-480, 70954-481
EstradiolMakes it, tests it, packages it and labels it ANI Pharmaceuticals, Inc. 70954-530, 70954-531, 70954-532 +6
EverolimusMakes it, tests it, packages it and labels it ANI Pharmaceuticals, Inc. 70954-773, 70954-774, 70954-775
FamotidineMakes it, tests it, packages it and labels it ANI Pharmaceuticals, Inc. 70954-316
FelbamateMakes it, tests it, packages it and labels it Novitium Pharma LLC 70954-051
FluconazoleMakes it Golden State Medical Supply, Inc. 51407-426
FludrocortisoneMakes it, tests it, packages it and labels it Novitium Pharma LLC 70954-252
FluphenazineMakes it, tests it, packages it and labels it ANI Pharmaceuticals, Inc. 70954-273, 70954-274, 70954-275 +1
FosfomycinMakes it, tests it, packages it and labels it ANI Pharmaceuticals, Inc. 70954-040
GlutamineMakes it, tests it, packages it and labels it ANI Pharmaceuticals, Inc. 70954-417
HydrochlorothiazideMakes it, tests it, packages it and labels it ANI Pharmaceuticals, Inc. 70954-522
HydrocortisoneMakes it, tests it, packages it and labels it ANI Pharmaceuticals, Inc. 70954-052, 70954-053, 70954-054
HydroxychloroquineMakes it, tests it, packages it and labels it ANI Pharmaceuticals, Inc. 70954-804, 70954-805
HydroxyzineMakes it, tests it, packages it and labels it ANI Pharmaceuticals, Inc. 70954-912
IndomethacinMakes it, tests it, packages it and labels it ANI Pharmaceuticals, Inc. 70954-637
KetoconazoleMakes it, tests it, packages it and labels it ANI Pharmaceuticals, Inc. 70954-662
LevocarnitineMakes it, tests it, packages it and labels it ANI Pharmaceuticals, Inc. 70954-492
LevofloxacinMakes it, tests it, packages it and labels it ANI Pharmaceuticals, Inc. 70954-852
LidocaineMakes it and packages it Novitium Pharma LLC 70954-518
LofexidineMakes it, tests it, packages it and labels it ANI Pharmaceuticals, Inc. 70954-909
MacitentanMakes it, tests it, packages it and labels it ANI Pharmaceuticals, Inc. 70954-025
MegestrolMakes it, tests it, packages it and labels it ANI Pharmaceuticals, Inc. 70954-896
MeloxicamMakes it, tests it, packages it and labels it ANI Pharmaceuticals, Inc. 70954-076, 70954-077
MethsuximideMakes it, tests it, packages it and labels it ANI Pharmaceuticals, Inc. 70954-228
MethyltestosteroneMakes it, tests it, packages it and labels it ANI Pharmaceuticals, Inc. 70954-255
NaproxenMakes it, tests it, packages it and labels it ANI Pharmaceuticals, Inc. 70954-151, 70954-925, 70954-928
NitrofurantoinMakes it, tests it, packages it and labels it ANI Pharmaceuticals, Inc., Northstar Rx LLC. 70954-496, 72603-176
OxybutyninMakes it, tests it, packages it and labels it ANI Pharmaceuticals, Inc. 70954-005
ParoxetineMakes it, tests it, packages it and labels it ANI Pharmaceuticals, Inc. 70954-319
PhenoxybenzamineMakes it, tests it, packages it and labels it Novitium Pharma LLC 70954-365
PirfenidoneMakes it, tests it, packages it and labels it ANI Pharmaceuticals, Inc. 70954-869, 70954-870
Potassium CationMakes it, tests it, packages it and labels it ANI Pharmaceuticals, Inc. 70954-197
PrednisoneMakes it and packages it ANI Pharmaceuticals, Inc. 70954-056
PrucaloprideMakes it, tests it, packages it and labels it ANI Pharmaceuticals, Inc. 70954-596, 70954-597
PyrazinamideMakes it and packages it ANI Pharmaceuticals, Inc. 70954-484
PyridostigmineMakes it and packages it Novitium Pharma LLC 70954-148
PyrimethamineMakes it, tests it, packages it and labels it Oakrum Pharma, LLC, Vyera Pharmaceuticals LLC 72647-330, 69413-330
RifabutinMakes it, tests it, packages it and labels it ANI Pharmaceuticals, Inc. 70954-041
RifampinMakes it, tests it, packages it and labels it ANI Pharmaceuticals, Inc. 70954-892, 70954-893
SelegilineMakes it and packages it Novitium Pharma LLC 70954-504
SertralineMakes it, tests it, packages it and labels it ANI Pharmaceuticals, Inc. 70954-899, 70954-900
SildenafilMakes it, tests it, packages it and labels it ANI Pharmaceuticals, Inc. 70954-168, 70954-407, 70954-408 +1
Sulfamethoxazole and TrimethoprimMakes it, tests it, packages it and labels it ANI Pharmaceuticals, Inc. 70954-258
TadalafilMakes it, tests it, packages it and labels it ANI Pharmaceuticals, Inc. 70954-433, 70954-434, 70954-435
TapentadolMakes it, tests it, packages it and labels it ANI Pharmaceuticals, Inc. 70954-801
TerazosinMakes it, tests it, packages it and labels it ANI Pharmaceuticals, Inc. 70954-592
ThiothixeneMakes it, tests it, packages it and labels it ANI Pharmaceuticals, Inc. 70954-014, 70954-015, 70954-016 +1
TranylcypromineMakes it and packages it Novitium Pharma LLC 70954-538
TrihexyphenidylMakes it and packages it Novitium Pharma LLC 70954-211, 70954-212
TrimethoprimMakes it and packages it Novitium Pharma LLC 70954-541
ValsartanMakes it, tests it, packages it and labels it ANI Pharmaceuticals, Inc. 70954-310

FDA inspection history

EndedResultProgramProblems noted
Feb 16, 2024No problems foundBioresearch Monitoring—
Mar 31, 2023No problems foundDrug Quality Assurance—
Jul 8, 2021No problems foundDrug Quality Assurance—
Feb 4, 2019Problems found, fixed voluntarilyDrug Quality Assurance—
May 9, 2018No problems foundDrug Quality Assurance—

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