Drug factory · FDA FEI 3013826490

Alembic Pharmaceuticals Limited

Derma Division, Plot no 779/P and 790/P, Vadodara, India

India: 1

No problems found at FDA's last inspection, Mar 10, 2023.

No Action Indicated: inspectors found no objectionable conditions.

2 drug inspections on record since 2020: 2 with no problems, 0 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
AcyclovirMakes it and tests it Alembic Pharmaceuticals Inc. 62332-248, 62332-423
AdapaleneMakes it and tests it Alembic Pharmaceuticals Inc., Alembic Pharmaceuticals Limited 62332-549, 46708-549
Adapalene and Benzoyl PeroxideMakes it and tests it Alembic Pharmaceuticals Inc., Alembic Pharmaceuticals Limited 62332-662, 46708-662
BetamethasoneMakes it and tests it Alembic Pharmaceuticals Inc., Alembic Pharmaceuticals Limited 62332-708, 46708-708
ClindamycinMakes it and tests it Alembic Pharmaceuticals Inc. 62332-623
ClobetasolMakes it and tests it Alembic Pharmaceuticals Inc., Alembic Pharmaceuticals Limited 62332-425, 62332-465, 62332-486 +7
DapsoneMakes it and tests it Alembic Pharmaceuticals Inc., Alembic Pharmaceuticals Limited 62332-551, 62332-663, 46708-551 +1
DesonideMakes it and tests it Alembic Pharmaceuticals Inc., Alembic Pharmaceuticals Limited 62332-485, 62332-550, 62332-632 +3
DiclofenacMakes it and tests it Alembic Pharmaceuticals Inc., Alembic Pharmaceuticals Limited, Medsource Pharmaceuticals 62332-487, 62332-581, 46708-487 +2
LidocaineMakes it and tests it Alembic Pharmaceuticals Inc., Alembic Pharmaceuticals Limited 62332-424, 46708-424
Lidocaine and PrilocaineMakes it and tests it Alembic Pharmaceuticals Inc., Alembic Pharmaceuticals Limited 62332-582, 46708-582
MetronidazoleMakes it and tests it Alembic Pharmaceuticals Inc., Alembic Pharmaceuticals Limited 62332-630, 46708-630
MupirocinMakes it and tests it Alembic Pharmaceuticals Inc., Alembic Pharmaceuticals Limited 62332-624, 46708-624
Nystatin and Triamcinolone AcetonideMakes it and tests it Alembic Pharmaceuticals Inc., Alembic Pharmaceuticals Limited 62332-585, 62332-606, 46708-606
TavaboroleMakes it Alembic Pharmaceuticals Inc. 62332-467
TretinoinMakes it and tests it Alembic Pharmaceuticals Inc., Alembic Pharmaceuticals Limited 62332-807, 62332-808, 62332-809 +3

FDA inspection history

EndedResultProgramProblems noted
Mar 10, 2023No problems foundDrug Quality Assurance—
Jan 8, 2020No problems foundBioresearch Monitoring—

Registered with FDA for: analysis; manufacture.