Drug factory · FDA FEI 3006026405

Zydus Lifesciences Limited

Plot No.254-255, Sarkhej-Bavla National Highway No. 8A Changodar, Tal-Sanand, Ahmedabad, India

India: 1

No problems found at FDA's last inspection, Feb 14, 2025.

No Action Indicated: inspectors found no objectionable conditions.

4 drug inspections on record since 2016: 3 with no problems, 1 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. 70771-1371, 70771-1808, 72578-082 +1
Adapalene and Benzoyl PeroxideMakes it and tests it Cadila Healthcare Limited, Viona Pharmaceuticals Inc. 70771-1716, 72578-119
Benzoyl Peroxide and ClindamycinMakes it and tests it Cadila Healthcare Limited, Zydus Pharmaceuticals (USA) Inc. 70771-1450, 70710-1445
BetamethasoneMakes it and tests it Cadila Healthcare Limited, Northstar Rx LLC., Viona Pharmaceuticals Inc., Zydus Pharmaceuticals (USA) Inc. 70771-1380, 70771-1550, 16714-996 +2
ClindamycinMakes it and tests it Cadila Healthcare Limited, Viona Pharmaceuticals Inc. 70771-1414, 70771-1855, 72578-084 +1
ClobetasolMakes it and tests it Cadila Healthcare Limited, Viona Pharmaceuticals Inc., Zydus Pharmaceuticals (USA) Inc. 70771-1080, 70771-1209, 70771-1498 +3
DapsoneMakes it and tests it Cadila Healthcare Limited, Viona Pharmaceuticals Inc. 70771-1538, 72578-094
DesonideMakes it and tests it Cadila Healthcare Limited, Viona Pharmaceuticals Inc. 70771-1381, 72578-086
DesoximetasoneMakes it and tests it Cadila Healthcare Limited, Viona Pharmaceuticals Inc. 70771-1166, 70771-1437, 72578-091 +1
FluocinonideMakes it and tests it Cadila Healthcare Limited, Viona Pharmaceuticals Inc., Zydus Pharmaceuticals (USA) Inc. 70771-1375, 70771-1393, 72578-087 +1
IndomethacinMakes it and tests it Cadila Healthcare Limited, Zydus Pharmaceuticals (USA) Inc. 70771-1766, 70710-1852, 70710-1958
IvermectinMakes it and tests it Cadila Healthcare Limited, Viona Pharmaceuticals Inc. 70771-1728, 72578-120
KetoconazoleMakes it and tests it Cadila Healthcare Limited, Viona Pharmaceuticals Inc. 70771-1874, 72578-156
Lactic AcidMakes it and tests it Cadila Healthcare Limited 70771-1988
Lidocaine and PrilocaineMakes it and tests it Cadila Healthcare Limited, Viona Pharmaceuticals Inc. 70771-1872, 72578-165
MesalamineMakes it and tests it Cadila Healthcare Limited, Northstar Rx LLC., Zydus Pharmaceuticals (USA) Inc. 70771-1513, 16714-245, 70710-1302
MetronidazoleMakes it and tests it Cadila Healthcare Limited, Viona Pharmaceuticals Inc. 70771-1834, 70771-1978, 72578-129 +1
MupirocinMakes it and tests it Cadila Healthcare Limited, Viona Pharmaceuticals Inc. 70771-1981, 72578-130
NystatinMakes it and tests it Cadila Healthcare Limited, Viona Pharmaceuticals Inc. 70771-1357, 72578-089
Nystatin and Triamcinolone AcetonideMakes it and tests it Cadila Healthcare Limited, Viona Pharmaceuticals Inc. 70771-1447, 72578-088
TavaboroleMakes it and tests it Cadila Healthcare Limited, Viona Pharmaceuticals Inc. 70771-1826, 72578-102
TretinoinMakes it and tests it Cadila Healthcare Limited, Viona Pharmaceuticals Inc. 70771-1873, 70771-1933, 72578-153 +1

FDA inspection history

EndedResultProgramProblems noted
Feb 14, 2025No problems foundDrug Quality Assurance—
Dec 20, 2019No problems foundDrug Quality Assurance—
Mar 28, 2018No problems foundDrug Quality Assurance—
Mar 18, 2016Problems found, fixed voluntarilyDrug Quality Assurance—

Registered with FDA for: analysis; manufacture.