Drug factory · FDA FEI 3008223599

Amneal Pharmaceuticals Private Limited

Survey No.634, 637 To 641, Near Hotel Kankavati Sarkhej-Bavla Highway, Village Rajoda, Tal Bavla, Ahmedabad, India

Problems found, fixed voluntarily at FDA's last inspection, Jan 24, 2025.

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

9 drug inspections on record since 2012: 5 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Abiraterone	Makes it, tests it, packages it and labels it	Amneal Pharmaceuticals	60219-1165, 60219-1754
Aripiprazole	Makes it, tests it, packages it and labels it	Amneal Pharmaceuticals	65162-896, 65162-897, 65162-898 +3
Budesonide	Makes it, tests it, packages it and labels it	Amneal Pharmaceuticals	53746-778
Carbidopa and Levodopa	Makes it, tests it, packages it and labels it	Amneal Pharmaceuticals, Zydus Pharmaceuticals (USA) Inc.	60219-2033, 60219-2034, 64896-661 +7
Carvedilol	Makes it, tests it, packages it and labels it	Amneal Pharmaceuticals	0115-1248, 0115-1249, 0115-1250 +1
Chloroquine	Makes it, tests it, packages it and labels it	Amneal Pharmaceuticals	0115-2790, 0115-7010
Chlorthalidone	Makes it, tests it, packages it and labels it	Amneal Pharmaceuticals	65162-247, 65162-250
Clindamycin	Makes it, tests it, packages it and labels it	Amneal Pharmaceuticals	53746-468
Colesevelam	Makes it, tests it, packages it and labels it	Amneal Pharmaceuticals	0115-1864
Colestipol	Makes it, tests it, packages it and labels it	Amneal Pharmaceuticals	0115-5211
Doxepin	Makes it, tests it, packages it and labels it	Amneal Pharmaceuticals	69238-1166, 69238-1170, 69238-1171 +2
Doxycycline	Makes it, tests it, packages it and labels it	Amneal Pharmaceuticals	69238-1100
Erythromycin	Makes it, tests it, packages it and labels it	Amneal Pharmaceuticals	60219-1503, 60219-1504
Everolimus	Packages it and labels it	Amneal Pharmaceuticals	60219-2279, 60219-2280, 60219-2281
Ezetimibe	Makes it, tests it, packages it and labels it	Amneal Pharmaceuticals	69238-1154
Famotidine	Makes it, tests it, packages it and labels it	Amneal Pharmaceuticals	60219-2090
Fenofibric Acid	Makes it, tests it, packages it and labels it	Amneal Pharmaceuticals	0115-1324, 0115-1325, 60219-5511 +1
Flecainide	Makes it, tests it, packages it and labels it	Amneal Pharmaceuticals	53746-641, 53746-642, 53746-643
Fludrocortisone	Makes it, tests it, packages it and labels it	Amneal Pharmaceuticals	0115-7033
Fosfomycin	Makes it, tests it, packages it and labels it	Amneal Pharmaceuticals	60219-3955
Frovatriptan	Packages it and labels it	Amneal Pharmaceuticals	69238-1539
Gabapentin	Makes it, tests it, packages it and labels it	Amneal Pharmaceuticals, RxChange Co.	65162-101, 65162-102, 65162-103 +1
Griseofulvin	Makes it, tests it, packages it and labels it	Amneal Pharmaceuticals	0115-1724, 0115-1725
Hydrocortisone	Makes it, tests it, packages it and labels it	Amneal Pharmaceuticals	0115-1696, 0115-1697, 0115-1700
Hydroxyzine	Makes it, tests it, packages it and labels it	Amneal Pharmaceuticals, NCS HealthCare of KY, Inc dba Vangard Labs	0115-1803, 0115-1804, 0615-8419 +1
Irbesartan	Makes it, tests it, packages it and labels it	Amneal Pharmaceuticals	65162-284, 65162-285, 65162-286
Itraconazole	Makes it, tests it, packages it and labels it	Amneal Pharmaceuticals	65162-630
Lacosamide	Makes it, tests it, packages it and labels it	Amneal Pharmaceuticals	53746-923, 53746-924, 53746-925 +1
Lamotrigine	Makes it, tests it, packages it and labels it	Amneal Pharmaceuticals	0115-9939, 0115-9940, 0115-9941 +1
Lurasidone	Makes it, tests it, packages it and labels it	Amneal Pharmaceuticals	65162-082, 65162-879, 65162-880 +2
Metaxalone	Makes it, tests it, packages it and labels it	Amneal Pharmaceuticals	65162-553
Metformin	Makes it, tests it, packages it and labels it	Amneal Pharmaceuticals	53746-218, 53746-219, 53746-220
Milnacipran	Makes it, tests it, packages it and labels it	Amneal Pharmaceuticals	65162-091, 65162-092, 65162-093 +1
Monomethyl	Makes it, tests it, packages it and labels it	Amneal Pharmaceuticals	69238-1318, 69238-1319, 69238-1626
Mycophenolic Acid	Makes it, tests it, packages it and labels it	Amneal Pharmaceuticals	60219-1595
Naproxen	Makes it, tests it, packages it and labels it	Amneal Pharmaceuticals	65162-188, 65162-189, 65162-190
Niacin	Makes it, tests it, packages it and labels it	Amneal Pharmaceuticals	65162-322
Oseltamivir Acid	Makes it, tests it, packages it and labels it	Amneal Pharmaceuticals	60219-1264, 60219-1265, 60219-1266
Pantoprazole	Makes it, tests it, packages it and labels it	Amneal Pharmaceuticals	65162-636, 65162-637
Pitavastatin	Makes it, tests it, packages it and labels it	Amneal Pharmaceuticals	65162-029, 65162-030, 65162-031
Potassium Cation	Makes it, tests it, packages it and labels it	Amneal Pharmaceuticals	60219-1617, 65162-542
Prasugrel	Makes it, tests it, packages it and labels it	Amneal Pharmaceuticals	65162-001, 65162-002
Propranolol	Makes it, tests it, packages it and labels it	Amneal Pharmaceuticals	69238-2077, 69238-2078, 69238-2079
Pyridostigmine	Makes it, tests it, packages it and labels it	Amneal Pharmaceuticals	0115-3511
Quinine	Makes it, tests it, packages it and labels it	Amneal Pharmaceuticals	65162-811
Rabeprazole	Makes it, tests it, packages it and labels it	Amneal Pharmaceuticals	65162-724
Rimantadine	Makes it, tests it, packages it and labels it	Amneal Pharmaceuticals	0115-1911
Sevelamer	Makes it, tests it, packages it and labels it	Amneal Pharmaceuticals	65162-058
Sildenafil	Makes it, tests it, packages it and labels it	Amneal Pharmaceuticals	60219-2651, 65162-351
Spironolactone	Makes it, tests it, packages it and labels it	Amneal Pharmaceuticals	53746-511, 53746-514, 53746-515
Sucralfate	Makes it, tests it, packages it and labels it	Amneal Pharmaceuticals	60219-1656
Telmisartan	Makes it, tests it, packages it and labels it	Amneal Pharmaceuticals	65162-291, 65162-292, 65162-293
Tramadol	Makes it, tests it, packages it and labels it	Amneal Pharmaceuticals	60219-2348
Valproic Acid	Makes it, tests it, packages it and labels it	Amneal Pharmaceuticals	65162-755, 65162-757
Valsartan	Makes it, tests it, packages it and labels it	Amneal Pharmaceuticals	53746-837, 53746-838, 53746-839 +1
Vigabatrin	Tests it, packages it and labels it	Amneal Pharmaceuticals	60219-1425
Warfarin	Makes it, tests it, packages it and labels it	Amneal Pharmaceuticals	65162-761, 65162-762, 65162-763 +6

FDA inspection history

Ended	Result	Program	Problems noted
Jan 24, 2025	Problems found, fixed voluntarily	Drug Quality Assurance	—
Jul 14, 2023	No problems found	Drug Quality Assurance	—
Feb 21, 2020	No problems found	Drug Quality Assurance	—
May 24, 2019	Problems found, fixed voluntarily	Drug Quality Assurance	2
Aug 24, 2018	No problems found	Drug Quality Assurance	—
Sep 22, 2017	No problems found	Drug Quality Assurance	—
Apr 12, 2017	No problems found	Drug Quality Assurance	—
Jan 30, 2015	Problems found, fixed voluntarily	Drug Quality Assurance	—
Aug 17, 2012	Problems found, fixed voluntarily	Drug Quality Assurance	—

What inspectors wrote down

From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.

May 24, 2019 inspection

Habits of good sanitation & health 21 CFR 211.28(b)
Production personnel were not practicing good sanitation and health habits.
Failure to meet specifications 21 CFR 314.81(b)(1)(ii)
An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning a failure of one or more distributed batches of a drug to meet the specifications established for it in the application.

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