Drug factory · FDA FEI 3007938603

Zydus Lifesciences Limited

Plot No. 1-A/1&2 PHARMEZ, (Special Economic Zone) Matoda, Sarkhej Bavla N.H. No. 8A, Tal-Sanand, Dist-Ahmedabad, Ahmedabad, India

India: 1

Problems found, fixed voluntarily at FDA's last inspection, Mar 24, 2023.

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

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

What it does, for whom

DrugRoleForNDC
AcyclovirMakes it and tests it Cadila Healthcare Limited, Viona Pharmaceuticals Inc., Zydus Pharmaceuticals (USA) Inc. 65841-829, 72578-002, 68382-668
AlbuterolMakes it and tests it Cadila Healthcare Limited, Zydus Pharmaceuticals (USA) Inc. 70771-1511, 70771-1512, 70710-1061 +1
AmantadineMakes it and tests it Cadila Healthcare Limited, Zydus Pharmaceuticals (USA) Inc. 65841-835, 68382-512
AmbrisentanMakes it and tests it Cadila Healthcare Limited, Quallent Pharmaceuticals Health LLC, Zydus Pharmaceuticals (USA) Inc. 70771-1363, 70771-1364, 82009-141 +3
AmitriptylineMakes it and tests it Cadila Healthcare Limited, Northstar Rx LLC., Zydus Pharmaceuticals (USA) Inc. 70771-1173, 70771-1174, 70771-1175 +15
Atenolol and ChlorthalidoneMakes it and tests it Cadila Healthcare Limited, Northstar Rx LLC., Zydus Pharmaceuticals (USA) Inc. 70771-1372, 70771-1373, 16714-936 +3
AtorvastatinMakes it and tests it Cadila Healthcare Limited, Zydus Pharmaceuticals (USA) Inc. 70771-1875, 70771-1876, 70771-1877 +5
BalsalazideMakes it and tests it Cadila Healthcare Limited, Zydus Pharmaceuticals (USA) Inc. 70771-1841, 70710-1626
BisoprololMakes it and tests it Cadila Healthcare Limited, Viona Pharmaceuticals Inc. 70771-1726, 70771-1727, 72578-111 +1
Bisoprolol and HydrochlorothiazideMakes it and tests it Cadila Healthcare Limited, Viona Pharmaceuticals Inc. 70771-1760, 70771-1761, 70771-1762 +3
BosentanMakes it and tests it Cadila Healthcare Limited, Zydus Pharmaceuticals (USA) Inc. 70771-1017, 70771-1018, 70771-1908 +3
BrivaracetamMakes it and tests it Cadila Healthcare Limited, Zydus Pharmaceuticals (USA) Inc. 70771-1754, 70771-1755, 70771-1756 +7
BudesonideMakes it and tests it Cadila Healthcare Limited, Northstar Rx LLC., Zydus Pharmaceuticals (USA) Inc. 70771-1075, 16714-829, 68382-720
CarbidopaMakes it and tests it Cadila Healthcare Limited, Zydus Pharmaceuticals (USA) Inc. 70771-1355, 70710-1221
Chloride IonMakes it and tests it Cadila Healthcare Limited, Zydus Pharmaceuticals (USA) Inc. 70771-1600, 68382-740
ChlorthalidoneMakes it and tests it Cadila Healthcare Limited, Northstar Rx LLC., Zydus Pharmaceuticals (USA) Inc. 70771-1369, 70771-1370, 16714-128 +3
CinacalcetMakes it and tests it Cadila Healthcare Limited, Zydus Pharmaceuticals (USA) Inc. 70771-1054, 70771-1055, 70771-1056 +3
ClomipramineMakes it and tests it Northstar Rx LLC. 16714-849, 16714-850, 16714-851
ColchiceineMakes it and tests it Cadila Healthcare Limited, Northstar Rx LLC., Zydus Pharmaceuticals (USA) Inc. 70771-1396, 70771-1590, 16714-039 +2
ColesevelamMakes it and tests it Cadila Healthcare Limited, Zydus Pharmaceuticals (USA) Inc. 70771-1368, 68382-619
ColestipolMakes it and tests it Cadila Healthcare Limited, Zydus Pharmaceuticals (USA) Inc. 70771-1653, 70710-1467
CyproheptadineMakes it and tests it Cadila Healthcare Limited, Zydus Pharmaceuticals (USA) Inc. 70771-1076, 70710-1110
DapagliflozinMakes it and tests it Cadila Healthcare Limited, Zydus Pharmaceuticals (USA) Inc. 70771-1714, 70771-1715, 70710-1380 +1
DarunavirMakes it and tests it Cadila Healthcare Limited, Viona Pharmaceuticals Inc. 70771-1745, 70771-1746, 72578-147 +1
DasatinibMakes it and tests it Cadila Healthcare Limited, Zydus Pharmaceuticals (USA) Inc. 70771-1901, 70771-1902, 70771-1903 +9
DeferasiroxMakes it and tests it Cadila Healthcare Limited, Zydus Pharmaceuticals (USA) Inc. 70771-1471, 70771-1472, 70771-1473 +3
DiltiazemMakes it and tests it Cadila Healthcare Limited, Zydus Pharmaceuticals (USA) Inc. 70771-1030, 70771-1031, 70771-1032 +19
DoxazosinMakes it and tests it Cadila Healthcare Limited, Zydus Pharmaceuticals (USA) Inc. 70771-1112, 70771-1113, 70771-1114 +5
DoxycyclineMakes it and tests it Cadila Healthcare Limited, Viona Pharmaceuticals Inc., Zydus Pharmaceuticals (USA) Inc. 65841-821, 65841-822, 65841-823 +17
DroxidopaMakes it and tests it Cadila Healthcare Limited, Zydus Pharmaceuticals (USA) Inc. 70771-1609, 70771-1610, 70771-1611 +3
EletriptanMakes it and tests it Cadila Healthcare Limited, Zydus Pharmaceuticals (USA) Inc. 70771-1107, 70771-1108, 68382-922 +1
EltrombopagMakes it and tests it Cadila Healthcare Limited, Zydus Pharmaceuticals (USA) Inc. 70771-1925, 70771-1926, 70771-1927 +5
Emtricitabine and TenofovirMakes it and tests it Cadila Healthcare Limited, Zydus Pharmaceuticals (USA) Inc. 70771-1620, 70771-1621, 70771-1622 +5
EntecavirMakes it and tests it Cadila Healthcare Limited, Zydus Pharmaceuticals (USA) Inc. 70771-1019, 70771-1020, 68382-920 +1
ErlotinibMakes it and tests it Cadila Healthcare Limited, Zydus Pharmaceuticals (USA) Inc. 70771-1521, 70771-1522, 70771-1523 +3
EsomeprazoleMakes it and tests it Cadila Healthcare Limited, Zydus Pharmaceuticals (USA) Inc. 70771-1493, 70771-1494, 68382-441 +1
ExemestaneMakes it and tests it Cadila Healthcare Limited, Zydus Pharmaceuticals (USA) Inc. 70771-1374, 68382-383
FamotidineMakes it and tests it Cadila Healthcare Limited, Zydus Pharmaceuticals (USA) Inc. 70771-1702, 70771-1703, 70710-1683 +1
Famotidine and IbuprofenMakes it and tests it Cadila Healthcare Limited, Viona Pharmaceuticals Inc. 70771-1924, 72578-214
FelbamateMakes it and tests it Cadila Healthcare Limited, Viona Pharmaceuticals Inc. 70771-1077, 70771-1078, 72578-056 +1
FingolimodMakes it and tests it Cadila Healthcare Limited, Zydus Pharmaceuticals (USA) Inc. 70771-1603, 68382-912
FluphenazineMakes it and tests it Cadila Healthcare Limited, Zydus Pharmaceuticals (USA) Inc. 70771-1581, 70771-1582, 70771-1583 +5
Hydrochlorothiazide and TriamtereneMakes it and tests it Cadila Healthcare Limited, Viona Pharmaceuticals Inc., Zydus Pharmaceuticals (USA) Inc. 70771-1361, 70771-1362, 70771-1474 +4
HydroxychloroquineMakes it and tests it Cadila Healthcare Limited 65841-633
IvabradineMakes it and tests it Cadila Healthcare Limited, Zydus Pharmaceuticals (USA) Inc. 70771-1863, 70771-1864, 70710-1471 +1
KetorolacMakes it and tests it Zydus Pharmaceuticals (USA) Inc. 70710-1710
LabetalolMakes it and tests it BluePoint Laboratories., Cadila Healthcare Limited, Zydus Pharmaceuticals (USA) Inc. 68001-381, 68001-382, 68001-383 +6
LamotrigineMakes it and tests it Cadila Healthcare Limited, Zydus Pharmaceuticals (USA) Inc. 65841-682, 65841-683, 65841-684 +17
LenalidomideMakes it and tests it Cadila Healthcare Limited, Zydus Pharmaceuticals (USA) Inc. 70771-1676, 70771-1677, 70771-1678 +9
LiothyronineMakes it and tests it Cadila Healthcare Limited, Northstar Rx LLC., Zydus Pharmaceuticals (USA) Inc. 70771-1606, 70771-1607, 70771-1608 +6
LoperamideMakes it and tests it Cadila Healthcare Limited, Viona Pharmaceuticals Inc. 70771-1769, 72578-138
LurasidoneMakes it and tests it Cadila Healthcare Limited, Zydus Pharmaceuticals (USA) Inc. 70771-1734, 70771-1735, 70771-1736 +7
MeclizineMakes it and tests it Cadila Healthcare Limited, Zydus Pharmaceuticals (USA) Inc. 70771-1539, 70771-1540, 70710-1161 +1
MesalamineMakes it and tests it Cadila Healthcare Limited, Zydus Pharmaceuticals (USA) Inc. 70771-1625, 68382-452
MetforminMakes it and tests it Cadila Healthcare Limited, Zydus Pharmaceuticals (USA) Inc. 65841-027, 65841-039, 65841-809 +5
Metformin and SitagliptinMakes it and tests it Cadila Healthcare Limited, Zydus Pharmaceuticals (USA) Inc. 70771-1859, 70771-1860, 70771-1879 +15
MethotrexateMakes it and tests it Cadila Healthcare Limited, Zydus Pharmaceuticals (USA) Inc. 70771-1058, 68382-775
MetoprololMakes it and tests it Cadila Healthcare Limited, Zydus Pharmaceuticals (USA) Inc. 70771-1338, 70771-1339, 70771-1340 +5
MidodrineMakes it and tests it Cadila Healthcare Limited, Zydus Pharmaceuticals (USA) Inc. 70771-1595, 70771-1596, 70771-1597 +3
MinocyclineMakes it and tests it Cadila Healthcare Limited, Zydus Pharmaceuticals (USA) Inc. 70771-1426, 70771-1427, 70771-1428 +3
MirabegronMakes it and tests it Cadila Healthcare Limited, Zydus Pharmaceuticals (USA) Inc. 70771-1752, 70771-1753, 70710-1159 +1
ModafinilMakes it and tests it Cadila Healthcare Limited, Viona Pharmaceuticals Inc. 70771-1051, 70771-1052, 72578-005 +1
MonomethylMakes it and tests it Cadila Healthcare Limited, Zydus Pharmaceuticals (USA) Inc. 70771-1530, 70771-1531, 70771-1532 +3
NadololMakes it and tests it Cadila Healthcare Limited, Zydus Pharmaceuticals (USA) Inc. 70771-1089, 70771-1090, 70771-1091 +3
NateglinideMakes it and tests it Cadila Healthcare Limited, Zydus Pharmaceuticals (USA) Inc. 70771-1015, 70771-1016, 68382-721 +1
NifedipineMakes it and tests it Cadila Healthcare Limited, Zydus Pharmaceuticals (USA) Inc. 70771-1190, 70771-1191, 70771-1192 +3
NortriptylineMakes it and tests it Zydus Pharmaceuticals (USA) Inc. 70710-1153, 70710-1154, 70710-1155 +1
PhytonadioneMakes it and tests it Cadila Healthcare Limited, Northstar Rx LLC., Zydus Pharmaceuticals (USA) Inc. 70771-1318, 16714-973, 70710-1014
Potassium CationMakes it and tests it Cadila Healthcare Limited, Zydus Pharmaceuticals (USA) Inc. 70771-1599, 68382-853, 68382-854 +1
ProchlorperazineMakes it and tests it Cadila Healthcare Limited, Zydus Pharmaceuticals (USA) Inc. 70771-1697, 70771-1698, 70710-1667 +1
PropafenoneMakes it and tests it Cadila Healthcare Limited, Zydus Pharmaceuticals (USA) Inc. 70771-1525, 70771-1526, 70771-1527 +3
PrucaloprideMakes it and tests it Cadila Healthcare Limited, Viona Pharmaceuticals Inc. 70771-1899, 70771-1900, 72578-221 +1
RamelteonMakes it and tests it Cadila Healthcare Limited, Zydus Pharmaceuticals (USA) Inc. 70771-1495, 70710-1344
RoflumilastMakes it and tests it Cadila Healthcare Limited, Zydus Pharmaceuticals (USA) Inc. 70771-1673, 70771-1674, 68382-624 +1
SelexipagMakes it and tests it Cadila Healthcare Limited, Zydus Pharmaceuticals (USA) Inc. 70771-1793, 70771-1794, 70771-1795 +15
SevelamerMakes it and tests it Cadila Healthcare Limited, Zydus Pharmaceuticals (USA) Inc. 70771-1520, 68382-824
SitagliptinMakes it and tests it Cadila Healthcare Limited, Zydus Pharmaceuticals (USA) Inc. 70771-1790, 70771-1791, 70771-1792 +6
SucralfateMakes it and tests it Cadila Healthcare Limited, Viona Pharmaceuticals Inc. 70771-1833, 72578-081
TeriflunomideMakes it and tests it Cadila Healthcare Limited, Zydus Pharmaceuticals (USA) Inc. 70771-1010, 70771-1011, 70710-1114 +1
TheophyllineMakes it and tests it Cadila Healthcare Limited, Viona Pharmaceuticals Inc. 70771-1782, 70771-1783, 72578-173 +1
TizanidineMakes it and tests it Cadila Healthcare Limited, Viona Pharmaceuticals Inc., Zydus Pharmaceuticals (USA) Inc. 70771-1067, 70771-1068, 70771-1069 +7
TofacitinibMakes it and tests it Cadila Healthcare Limited, Zydus Pharmaceuticals (USA) Inc. 70771-1627, 70771-1628, 70710-1353 +1
TopiramateMakes it and tests it Cadila Healthcare Limited, Zydus Pharmaceuticals (USA) Inc. 70771-1656, 70771-1657, 70771-1658 +7
TrazodoneMakes it and tests it Cadila Healthcare Limited, Medsource Pharmaceuticals, Zydus Pharmaceuticals (USA) Inc. 70771-1128, 70771-1129, 70771-1130 +8
UrsodiolMakes it and tests it Cadila Healthcare Limited, Zydus Pharmaceuticals (USA) Inc. 70771-1524, 70710-1483
VardenafilMakes it and tests it Cadila Healthcare Limited, Zydus Pharmaceuticals (USA) Inc. 70771-1047, 70771-1048, 70771-1049 +5
VareniclineMakes it and tests it Cadila Healthcare Limited, Zydus Pharmaceuticals (USA) Inc. 70771-1773, 70771-1774, 70710-1613 +1
VenlafaxineMakes it and tests it Cadila Healthcare Limited, Zydus Pharmaceuticals (USA) Inc. 70771-1649, 70771-1650, 70771-1651 +5
VigabatrinMakes it and tests it Cadila Healthcare Limited, Zydus Pharmaceuticals (USA) Inc. 70771-1654, 70710-1287

FDA inspection history

EndedResultProgramProblems noted
Mar 24, 2023Problems found, fixed voluntarilyDrug Quality Assurance—
Apr 2, 2019Problems found, fixed voluntarilyDrug Quality Assurance—
Jan 24, 2017Problems found, fixed voluntarilyDrug Quality Assurance—
Jan 22, 2016Problems found, fixed voluntarilyDrug Quality Assurance—
Feb 27, 2015Problems found, fixed voluntarilyDrug Quality Assurance—

Registered with FDA for: analysis; manufacture.