Drug factory · FDA FEI 3003849479

Aphena Pharma Solutions - Tennessee, LLC

1920 Fisk Road, Cookeville, TN, United States

No problems found at FDA's last inspection, Jul 25, 2022.

No Action Indicated: inspectors found no objectionable conditions.

22 drug inspections on record since 2010: 7 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Acarbose	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-908
Acetaminophen and Butalbital and Caffeine	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	67544-394, 71610-042
Acetaminophen and Codeine	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	67544-001, 67544-002, 67544-003 +2
Acyclovir	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-883, 43353-933, 53401-031
Alfuzosin	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-746, 43353-945
Allopurinol	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-088, 43353-186, 53401-019 +12
Alogliptin	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	71610-300, 71610-661
Alprazolam	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	67544-005, 67544-290, 67544-347 +7
Amantadine	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-947
Amiodarone	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	67544-570, 71610-787
Amitriptyline	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-163, 43353-164, 71610-695 +6
Amlodipine	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-251, 43353-989, 71610-469 +15
Amphetamine	Packages it and labels it	Neos Therapeutics Brands, LLC	70165-005, 70165-010, 70165-015 +3
Apixaban	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	71610-662, 71610-811
Aripiprazole	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-848, 43353-849, 43353-850
Atenolol	Repackages it and relabels it	Aphena Pharma Solutions - Tennessee, Inc.	43353-830, 43353-833, 43353-834 +5
Atenolol and Chlorthalidone	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-149
Atorvastatin	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-115, 43353-120, 43353-280 +19
Atropine and Diphenoxylate	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-083, 43353-594, 67544-021 +2
Azathioprine	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-745, 71610-124, 71610-306
Azithromycin	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-693, 71610-381
Baclofen	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	67544-671, 71610-391, 71610-444 +5
Benzonatate	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	71610-692
Benztropine	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-796, 43353-913, 71610-502
Bumetanide	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-288
Bupropion	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-189, 43353-538, 43353-546 +21
Buspirone	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-607, 43353-609, 43353-610 +25
Calcitriol	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-034, 43353-633, 71610-468 +2
Carbamazepine	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-953, 71610-336, 71610-782
Carbidopa and Levodopa	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-202, 43353-327, 43353-510 +4
Carisoprodol	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-102, 67544-012, 71610-097 +2
Carvedilol	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-132, 43353-133, 43353-156 +7
Celecoxib	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-036, 67544-204, 71610-584
Chlordiazepoxide	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	71610-263
Chlorthalidone	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-922, 71610-021, 71610-029 +2
Cilostazol	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	71610-813, 71610-822
Ciprofloxacin	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-924, 71610-081, 71610-109 +1
Citalopram	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-112, 43353-208, 43353-778 +4
Clonazepam	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-277, 43353-799, 67544-289 +18
Clonidine	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-316, 71610-449
Clopidogrel	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-269, 71610-527
Colchicine	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-854, 71610-494
Cyclobenzaprine	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	67544-251, 71610-016, 71610-379 +3
Dexlansoprazole	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	53401-030
Diazepam	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-783, 43353-820, 43353-825 +3
Diclofenac	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	67544-840, 67544-899, 71610-068
Dicyclomine	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	71610-209, 71610-265
Digoxin	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	71610-019
Diltiazem	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-888, 43353-889, 43353-903 +2
Doxazosin	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-647, 43353-648, 67544-273 +11
Doxepin	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-329, 43353-331
Doxycycline	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-923, 71610-087
Duloxetine	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-303, 71610-218, 71610-401 +7
Empagliflozin	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	71610-177, 71610-900
Entacapone	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-996, 71610-247
Ergocalciferol	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-238, 43353-828, 53401-021 +2
Escitalopram	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	53401-037, 71610-425, 71610-534
Estrogens, Conjugated	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-687, 43353-688
Eszopiclone	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-185, 43353-200, 71610-409
Etodolac	Repackages it and relabels it	Aphena Pharma Solutions - Tennessee, Inc.	43353-749, 43353-752, 43353-753 +7
Famotidine	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	53401-036, 71610-399, 71610-470
Febuxostat	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-305, 71610-386, 71610-411 +2
Fenofibrate	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-032
Fexofenadine	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-244
Finasteride	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	71610-515, 71610-520
Fluoxetine	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	53401-024, 67544-848, 71610-024 +4
Folic Acid	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-681, 43353-824, 71610-235 +5
Fosinoprilat	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-870, 67544-431
Furosemide	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-069, 43353-220, 43353-221 +14
Gabapentin	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-075, 43353-081, 43353-190 +35
Gemfibrozil	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-090, 71610-107, 71610-200 +2
Glimepiride	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	71610-236
Glipizide	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-207, 67544-129, 71610-105 +3
Glyburide	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-656, 43353-659, 43353-895
Glyburide and Metformin	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	67544-511
Hydralazine	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-124, 43353-205, 43353-742 +6
Hydrochlorothiazide	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-635, 43353-717, 43353-719 +9
Hydrochlorothiazide and Lisinopril	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-563, 43353-800, 43353-865 +9
Hydrochlorothiazide and Losartan	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-926, 71610-671
Hydrochlorothiazide and Triamterene	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	71610-431, 71610-602, 71610-605 +1
Hydrochlorothiazide and Valsartan	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	71610-327
Hydroxychloroquine	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	53401-040, 71610-047, 71610-473 +3
Hydroxyzine	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	53401-034, 71610-217, 71610-397 +7
Ibuprofen	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-095, 43353-273, 43353-314 +26
Isoniazid	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	71610-395
Isosorbide Mononitrate	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-917, 67544-224, 67544-236 +6
Levothyroxine	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-336
Lisinopril	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-009, 43353-270, 43353-271 +17
Lithium Cation	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	67544-534, 71610-557
Loperamide	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	67544-700, 71610-648, 71610-781 +2
Lorazepam	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	71610-178, 71610-199, 71610-225 +11
Losartan	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-299, 71610-065, 71610-083 +9
Lovastatin	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-763, 71610-396, 71610-709 +1
Meloxicam	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-038, 43353-127, 43353-979 +11
Memantine	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-170, 71610-011, 71610-885 +1
Metformin	Repackages it and relabels it	Aphena Pharma Solutions - Tennessee, Inc.	43353-082, 43353-098, 43353-340 +36
Methocarbamol	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-436, 43353-779, 43353-948 +10
Methylphenidate	Packages it and labels it	Neos Therapeutics Brands, LLC	70165-100, 70165-200, 70165-300
Metoclopramide	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-808, 53401-027
Metolazone	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-890, 43353-931, 71610-285 +1
Metoprolol	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-016, 43353-583, 43353-795 +39
Minoxidil	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-342
Mirtazapine	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-378, 43353-535, 43353-536 +12
Modafinil	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-831, 43353-925, 43353-956 +5
Montelukast	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-879, 71610-051, 71610-129 +1
Naltrexone	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	53401-008, 53401-023, 71610-919 +1
Naproxen	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-211, 43353-216, 43353-218 +11
Nifedipine	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-209, 43353-782, 43353-792 +8
Nortriptyline	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	67544-078, 71610-785
Olanzapine	Repackages it and relabels it	Aphena Pharma Solutions - Tennessee, Inc.	43353-954, 71610-419
Omeprazole	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-829, 71610-248, 71610-280 +12
Ondansetron	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-881, 71610-119
Oxazepam	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-074, 67544-117, 67544-268 +1
Oxybutynin	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-282, 43353-284, 43353-285 +7
Oxycodone	Packages it	Knoa Pharma LLC	59011-410, 59011-415, 59011-420 +4
Pantoprazole	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-027, 43353-338, 43353-569 +9
Paroxetine	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-544, 43353-554, 43353-713 +8
Pentoxifylline	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-123, 67544-252
Phenobarbital	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	67544-057
Phenytoin	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-131, 67544-517, 71610-869 +1
Pioglitazone	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	71610-495, 71610-497
Piroxicam	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	67544-807
Potassium Cation	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-064, 43353-215, 43353-790 +10
Pravastatin	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-474, 43353-927, 71610-637 +3
Prazosin	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-035, 43353-868, 71610-693 +4
Prednisone	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-657, 43353-819, 67544-399 +1
Pregabalin	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	53401-007, 71610-313, 71610-314 +56
Primidone	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	71610-540, 71610-590, 71610-763
Probenecid	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-839
Propranolol	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-084, 43353-701, 43353-706 +5
Quetiapine	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-150, 43353-153, 43353-155 +16
Raloxifene	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	71610-053, 71610-504, 71610-524
Ranitidine	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-967, 43353-971, 71610-359 +3
Ranolazine	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	71610-322, 71610-518, 71610-971
Risperidone	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-754, 43353-755, 43353-757 +6
Rivaroxaban	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	71610-690
Ropinirole	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-194, 43353-195, 43353-196 +4
Rosuvastatin	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-031, 43353-289, 43353-290 +13
Sacubitrilat and Valsartan	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	71610-806, 71610-807, 71610-810 +6
Sertraline	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-447, 43353-809, 43353-812 +7
Sevelamer	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	67544-656
Sildenafil	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-764, 53401-046, 67544-355 +3
Simvastatin	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-664, 43353-768, 43353-773 +20
Sotalol	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	71610-074, 71610-294, 71610-385 +4
Spironolactone	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	53401-041, 67544-310, 71610-102 +4
Sucralfate	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-061, 71610-017, 71610-244 +1
Sulfamethoxazole and Trimethoprim	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-368
Sulfasalazine	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-495, 71610-706
Tacrolimus	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-178, 43353-317
Tadalafil	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-044, 43353-070, 43353-857 +15
Tamsulosin	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-663, 71610-724, 71610-738 +2
Temazepam	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-260, 43353-312, 43353-711 +9
Terazosin	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	53401-022, 67544-562, 67544-563 +14
Terbinafine	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-893
Ticagrelor	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	53401-028, 71610-815, 71610-914 +1
Tizanidine	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	71610-228, 71610-345, 71610-355 +3
Topiramate	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	71610-193, 71610-485, 71610-486 +2
Torsemide	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-315, 71610-819
Tramadol	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-072, 71610-392, 71610-865
Trazodone	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-652, 43353-653, 53401-043 +10
Triazolam	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-451, 67544-725
Trospium	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	71610-812
Valproic Acid	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-085, 43353-279, 43353-310 +12
Valsartan	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-203, 53401-029, 53401-033 +2
Vardenafil	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	71610-310, 71610-477, 71610-508
Varenicline	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-899, 53401-032
Venlafaxine	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-689, 43353-690, 43353-869 +2
Verapamil	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	71610-258, 71610-268, 71610-377 +1
Warfarin	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-021, 43353-023, 43353-028 +28
Zolpidem	Repackages it	Aphena Pharma Solutions - Tennessee, Inc.	43353-242, 43353-243, 43353-617 +15

FDA inspection history

Ended	Result	Program	Problems noted
Jul 25, 2022	No problems found	Drug Quality Assurance	—
Jul 25, 2022	No problems found	Drug Quality Assurance	—
Jul 9, 2021	No problems found	Drug Quality Assurance	—
Jul 9, 2021	No problems found	Drug Quality Assurance	—
Nov 16, 2017	Problems found, fixed voluntarily	Drug Quality Assurance	—
Nov 16, 2017	Problems found, fixed voluntarily	Drug Quality Assurance	—
Nov 30, 2016	No problems found	Drug Quality Assurance	—
Nov 30, 2016	No problems found	Drug Quality Assurance	—
Jun 13, 2016	Problems found, fixed voluntarily	Drug Quality Assurance	—
Jun 13, 2016	Problems found, fixed voluntarily	Drug Quality Assurance	—
Feb 28, 2014	Problems found, fixed voluntarily	Drug Quality Assurance	—
Feb 28, 2014	Problems found, fixed voluntarily	Drug Quality Assurance	—
Dec 12, 2013	Problems found, fixed voluntarily	Drug Quality Assurance	—
Dec 12, 2013	Problems found, fixed voluntarily	Drug Quality Assurance	—
Oct 1, 2012	No problems found	Drug Quality Assurance	—
Oct 1, 2012	No problems found	Drug Quality Assurance	—
Aug 4, 2011	No problems found	Drug Quality Assurance	—
Aug 4, 2011	No problems found	Drug Quality Assurance	—
Aug 20, 2010	No problems found	Drug Quality Assurance	—
Aug 20, 2010	No problems found	Drug Quality Assurance	—
Feb 19, 2010	No problems found	Drug Quality Assurance	—
Feb 19, 2010	No problems found	Drug Quality Assurance	—

Registered with FDA for: label; pack; relabel; repack.