Drug factory · FDA FEI 3010254278

Amneal Pharmaceuticals Private Limited

Plot No. 15, 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, Jun 19, 2024.

No Action Indicated: inspectors found no objectionable conditions.

7 drug inspections on record since 2015: 2 with no problems, 5 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
ArgatrobanMakes it, tests it, packages it and sterilizes it Amneal Pharmaceuticals LLC 70121-1037
AtropineMakes it, tests it, packages it and sterilizes it Amneal Pharmaceuticals, Amneal Pharmaceuticals LLC 60219-1748, 60219-1749, 60219-1750 +2
BimatoprostMakes it, tests it, packages it and sterilizes it Amneal Pharmaceuticals 60219-2149
BromfenacMakes it, tests it, packages it and sterilizes it Amneal Pharmaceuticals 60219-1526
Calcitonin SalmonMakes it, tests it, packages it and sterilizes it Amneal Pharmaceuticals LLC 70121-1650
Calcium CationMakes it, tests it, packages it and sterilizes it Amneal Pharmaceuticals LLC 70121-2308
CarboprostMakes it, tests it, packages it and sterilizes it Amneal Pharmaceuticals LLC 70121-1680
Ciprofloxacin and DexamethasoneMakes it, tests it, packages it and sterilizes it Amneal Pharmaceuticals 53746-831
DexamethasoneMakes it, tests it, packages it and sterilizes it Amneal Pharmaceuticals LLC 70121-1399, 70121-1450, 70121-1451 +1
DexmedetomidineMakes it, tests it, packages it and sterilizes it Amneal Pharmaceuticals LLC 70121-1388, 70121-1389
DifluprednateMakes it, tests it, packages it and sterilizes it Amneal Pharmaceuticals 69238-1380
DihydroergotamineMakes it, tests it, packages it and sterilizes it Amneal Pharmaceuticals 64896-509
DoxycyclineMakes it, tests it, packages it and sterilizes it Amneal Pharmaceuticals LLC 70121-1616
EpinephrineMakes it, tests it, packages it and sterilizes it Amneal Pharmaceuticals LLC 70121-1660
ExenatideMakes it, tests it, packages it and sterilizes it Amneal Pharmaceuticals LLC 70121-1685, 70121-1686
FulvestrantMakes it and tests it BluePoint Laboratories. 68001-484
FurosemideMakes it, tests it, packages it and sterilizes it Amneal Pharmaceuticals LLC 70121-1076, 70121-1163, 70121-1164
GlycopyrroniumMakes it, tests it, packages it and sterilizes it Amneal Pharmaceuticals LLC 70121-1698, 70121-1699
Hydrocortisone and Neomycin and Polymyxin BMakes it, tests it, packages it and sterilizes it Amneal Pharmaceuticals 60219-2083, 60219-2084
LabetalolMakes it, tests it, packages it and sterilizes it Amneal Pharmaceuticals LLC 70121-2428
LevoleucovorinMakes it, tests it, packages it and sterilizes it Amneal Pharmaceuticals LLC 70121-1572
LoteprednolMakes it, tests it, packages it and sterilizes it Amneal Pharmaceuticals 60219-1362, 60219-1366, 60219-1367
MethylprednisoloneMakes it, tests it, packages it and sterilizes it Amneal Pharmaceuticals LLC 70121-1000, 70121-1001, 70121-1609 +1
ParicalcitolMakes it, tests it, packages it and sterilizes it Amneal Pharmaceuticals LLC 70121-1033, 70121-1034, 70121-1035 +1
PhenylephrineMakes it, tests it, packages it and sterilizes it Amneal Pharmaceuticals LLC 70121-1577, 70121-1578, 70121-1579
PhytonadioneMakes it, tests it, packages it and sterilizes it Amneal Pharmaceuticals LLC 70121-1682
PilocarpineMakes it, tests it, packages it and sterilizes it Amneal Pharmaceuticals 60219-2366, 60219-2649
PrednisoloneMakes it, tests it, packages it and sterilizes it Amneal Pharmaceuticals 60219-2550, 60219-2551, 60219-2552
ProchlorperazineMakes it, tests it, packages it and sterilizes it Amneal Pharmaceuticals LLC 70121-1580
RisperidoneMakes it, tests it, packages it and sterilizes it Amneal Pharmaceuticals LLC 70121-2625, 70121-2626, 70121-2627 +1
Triamcinolone AcetonideMakes it, tests it, packages it and sterilizes it Amneal Pharmaceuticals LLC, Northstar Rx LLC. 70121-1049, 70121-1168, 70121-1169 +3
VasopressinMakes it, tests it, packages it and sterilizes it Amneal Pharmaceuticals LLC 70121-1642

FDA inspection history

EndedResultProgramProblems noted
Jun 19, 2024No problems foundDrug Quality Assurance—
Dec 23, 2022Problems found, fixed voluntarilyDrug Quality Assurance—
Feb 18, 2020No problems foundDrug Quality Assurance—
Apr 5, 2019Problems found, fixed voluntarilyDrug Quality Assurance—
Apr 24, 2018Problems found, fixed voluntarilyDrug Quality Assurance—
Mar 21, 2017Problems found, fixed voluntarilyDrug Quality Assurance—
Aug 25, 2015Problems found, fixed voluntarilyDrug Quality Assurance—

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