Drug factory · FDA FEI 3010661577

Amneal Pharmaceuticals Private Limited

Plot No 16 & 17, PHARMEZ Special Economic Zone Sarkhej-Bavla N.H. No. 8A, Vil.: Matoda, Tal.: Sanand, Ahmedabad, India

India: 1

No problems found at FDA's last inspection, Jul 19, 2024.

No Action Indicated: inspectors found no objectionable conditions.

6 drug inspections on record since 2015: 5 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
AbirateroneMakes it, tests it, packages it and labels it Amneal Pharmaceuticals 60219-1165
AcebutololMakes it, tests it, packages it and labels it Amneal Pharmaceuticals 53746-669, 53746-670
AlbuterolMakes it, tests it, packages it and labels it Amneal Pharmaceuticals 69238-1344, 69238-1345
AlosetronMakes it, tests it, packages it and labels it Amneal Pharmaceuticals 53746-248, 53746-249
Aminocaproic AcidMakes it, tests it, packages it and labels it Amneal Pharmaceuticals 69238-1637
BenazeprilatMakes it, tests it, packages it and labels it Amneal Pharmaceuticals 53746-751, 53746-752, 53746-753 +1
BethanecholMakes it, tests it, packages it and labels it Amneal Pharmaceuticals 53746-571, 53746-572, 53746-573 +1
BumetanideMakes it and packages it Amneal Pharmaceuticals 69238-1489, 69238-1490, 69238-1491
Chlordiazepoxide and ClidiniumMakes it, tests it, packages it and labels it Amneal Pharmaceuticals 60219-1677
ColestipolMakes it, tests it, packages it and labels it Amneal Pharmaceuticals 0115-5211
CyclobenzaprineMakes it, tests it, packages it and labels it Amneal Pharmaceuticals 65162-540, 65162-541
CyproheptadineMakes it, tests it, packages it and labels it Amneal Pharmaceuticals 0115-1757
DantroleneMakes it, tests it, packages it and labels it Amneal Pharmaceuticals 0115-4411, 0115-4422, 0115-4433
DarunavirMakes it, tests it, packages it and labels it Amneal Pharmaceuticals 60219-1144, 60219-1145
DeferasiroxMakes it, tests it, packages it and labels it Amneal Pharmaceuticals 69238-1486, 69238-1487, 69238-1488
DeflazacortMakes it, tests it, packages it and labels it Amneal Pharmaceuticals 60219-2282, 60219-2283, 60219-2284 +1
DemeclocyclineMakes it, tests it, packages it and labels it Amneal Pharmaceuticals 53746-554, 53746-555
DesipramineMakes it and packages it Amneal Pharmaceuticals 69238-1053, 69238-1055, 69238-1057 +3
DexamethasoneMakes it, tests it, packages it and labels it Amneal Pharmaceuticals 60219-2056
DipyridamoleMakes it, tests it, packages it and labels it Amneal Pharmaceuticals 0115-1070, 0115-1071, 0115-1072
EltrombopagMakes it, tests it, packages it and labels it Amneal Pharmaceuticals 60219-1414, 60219-1415, 60219-1416 +1
Emtricitabine and TenofovirMakes it, tests it, packages it and labels it Amneal Pharmaceuticals 69238-2092, 69238-2093, 69238-2094 +1
ErythromycinMakes it and packages it Amneal Pharmaceuticals 69238-1471, 69238-1472, 69238-1473
Ethacrynic AcidMakes it and packages it Amneal Pharmaceuticals 69238-1126
EtodolacMakes it and packages it Amneal Pharmaceuticals 69238-1342, 69238-1343
EverolimusMakes it, tests it, packages it and labels it Amneal Pharmaceuticals 60219-2279, 60219-2280, 60219-2281
EzetimibeMakes it, tests it, packages it and labels it Amneal Pharmaceuticals 69238-1154
FelbamateMakes it, tests it, packages it and labels it Amneal Pharmaceuticals 53746-734, 53746-735
Fenofibric AcidMakes it, tests it, packages it and labels it Amneal Pharmaceuticals 60219-5511, 60219-5522
FluphenazineMakes it, tests it, packages it and labels it Amneal Pharmaceuticals 69238-1678, 69238-1679, 69238-1680 +1
FrovatriptanMakes it Amneal Pharmaceuticals 69238-1539
HydroxyzineMakes it, tests it, packages it and labels it Amneal Pharmaceuticals, NCS HealthCare of KY, Inc dba Vangard Labs 0115-1803, 0115-1804, 0615-8419 +1
IbuprofenMakes it and packages it Amneal Pharmaceuticals 65162-464, 65162-465, 65162-466
LenalidomideMakes it, tests it, packages it and labels it Amneal Pharmaceuticals 60219-1714, 60219-1715, 60219-1716 +3
MacitentanMakes it, tests it, packages it and labels it Amneal Pharmaceuticals 69238-1327
MeclizineMakes it, tests it, packages it and labels it Amneal Pharmaceuticals 53746-441, 53746-442
MemantineMakes it, tests it, packages it and labels it Amneal Pharmaceuticals 65162-169, 65162-173
NadololMakes it, tests it, packages it and labels it Amneal Pharmaceuticals 69238-1123, 69238-1124, 69238-1125
NaproxenMakes it, tests it, packages it and labels it Amneal Pharmaceuticals 65162-188, 65162-189, 65162-190
NitrofurantoinMakes it, tests it, packages it and labels it Amneal Pharmaceuticals 0115-1643, 0115-1645
Oseltamivir AcidMakes it and tests it Amneal Pharmaceuticals 60219-1264, 60219-1265, 60219-1266
OxaprozinMakes it, tests it, packages it and labels it Amneal Pharmaceuticals 69238-1120
PhytonadioneMakes it, tests it, packages it and labels it Amneal Pharmaceuticals 69238-1051
PirfenidoneMakes it, tests it, packages it and labels it Amneal Pharmaceuticals 60219-1642
PregabalinMakes it, tests it, packages it and labels it Amneal Pharmaceuticals 69238-1310, 69238-1311, 69238-1312 +5
ProchlorperazineMakes it, tests it, packages it and labels it Amneal Pharmaceuticals 60219-2038, 60219-2039
PromethazineMakes it, tests it, packages it and labels it Amneal Pharmaceuticals 53746-521, 53746-522, 53746-745
PropranololMakes it, tests it, packages it and labels it Amneal Pharmaceuticals 69238-2077, 69238-2078, 69238-2079 +2
SevelamerMakes it, tests it, packages it and labels it Amneal Pharmaceuticals 65162-058
SilodosinMakes it, tests it, packages it and labels it Amneal Pharmaceuticals 69238-1420, 69238-1421
Sulfamethoxazole and TrimethoprimMakes it, tests it, packages it and labels it Amneal Pharmaceuticals 65162-271, 65162-272
TemazepamMakes it, tests it, packages it and labels it Amneal Pharmaceuticals 53746-556, 53746-557
TerbutalineMakes it, tests it, packages it and labels it Amneal Pharmaceuticals 0115-2611, 0115-2622
TetracyclineMakes it, tests it, packages it and labels it Amneal Pharmaceuticals 60219-1522, 60219-1523
TheophyllineMakes it, tests it, packages it and labels it Amneal Pharmaceuticals 60219-2045, 60219-2046
TioproninMakes it, tests it, packages it and labels it Amneal Pharmaceuticals 60219-2009
TramadolMakes it, tests it, packages it and labels it Amneal Pharmaceuticals 60219-2348
VigabatrinMakes it and tests it Amneal Pharmaceuticals 60219-1425

FDA inspection history

EndedResultProgramProblems noted
Jul 19, 2024No problems foundBioresearch Monitoring—
Jun 9, 2023No problems foundDrug Quality Assurance—
Jul 19, 2019Problems found, fixed voluntarilyDrug Quality Assurance—
May 3, 2018No problems foundDrug Quality Assurance—
Nov 10, 2017No problems foundDrug Quality Assurance—
Mar 19, 2015No problems foundDrug Quality Assurance—

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