Drug factory · FDA FEI 3017573557

Amneal Pharmaceuticals Private Limited

Survey No. 168/1/1, Pipan, Sanand, Ahmedabad, India

India: 1

No problems found at FDA's last inspection, Aug 30, 2024.

No Action Indicated: inspectors found no objectionable conditions.

1 drug inspection on record since 2024: 1 with no problems, 0 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
Acetate IonMakes it, tests it, packages it, labels it and sterilizes it Amneal Pharmaceuticals Private Limited 80830-2435, 80830-2436, 80830-2437
Bicarbonate IonMakes it, tests it, packages it, labels it and sterilizes it Amneal Pharmaceuticals Private Limited 80830-2305, 80830-2613
Calcium CationMakes it, tests it, packages it, labels it and sterilizes it Amneal Pharmaceuticals LLC, Amneal Pharmaceuticals Private Limited 70121-2309, 80830-1672, 80830-1673 +3
CarboprostMakes it, tests it, packages it, labels it and sterilizes it Amneal Pharmaceuticals LLC 70121-1680
Cupric CationMakes it, tests it, packages it, labels it and sterilizes it Amneal Pharmaceuticals Private Limited 80830-2301
EpinephrineMakes it, tests it, packages it, labels it and sterilizes it Amneal Pharmaceuticals Private Limited 80830-1659
FurosemideMakes it, tests it, packages it, labels it and sterilizes it Amneal Pharmaceuticals LLC 70121-1076
IohexolMakes it, tests it, packages it, labels it and sterilizes it Amneal Pharmaceuticals Private Limited 80830-2466, 80830-2467, 80830-2468 +3
MetronidazoleMakes it, tests it, packages it, labels it and sterilizes it Amneal Pharmaceuticals Private Limited 80830-2465
PhenylephrineMakes it, tests it, packages it, labels it and sterilizes it Amneal Pharmaceuticals LLC 70121-1577, 70121-1578, 70121-1579
Phosphate IonMakes it, tests it, packages it, labels it and sterilizes it Amneal Pharmaceuticals Private Limited 80830-2310
PhytonadioneMakes it, tests it, packages it, labels it and sterilizes it Amneal Pharmaceuticals Private Limited 80830-1683
Potassium CationMakes it, tests it, packages it, labels it and sterilizes it Amneal Pharmaceuticals LLC, Amneal Pharmaceuticals Private Limited 70121-1722, 80830-1691, 80830-1692 +1
PropofolMakes it, tests it, packages it, labels it and sterilizes it Amneal Pharmaceuticals Private Limited 80830-1188, 80830-2364, 80830-2365
Tranexamic AcidMakes it, tests it, packages it, labels it and sterilizes it Amneal Pharmaceuticals Private Limited 80830-2329

FDA inspection history

EndedResultProgramProblems noted
Aug 30, 2024No problems foundDrug Quality Assurance—

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