Is ANI Pharmaceuticals, Inc. FDA approved?

ANI Pharmaceuticals, Inc. holds 1 FDA-registered establishment in the United States. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.

Where are ANI Pharmaceuticals, Inc.'s drugs manufactured?

The FDA register lists Baudette, MN. Registered operations: analytical testing, labelling, finished drug manufacture, packaging.

What drugs does ANI Pharmaceuticals, Inc. make?

299 products are listed under ANI Pharmaceuticals, Inc. in the openFDA NDC Directory, most often as tablet; capsule; capsule, extended release. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

ANI Pharmaceuticals, Inc.

Data as of 24 Sept 2026 · How to read this entry

Request a quote Claim this profile

Registered sites: 1
Active NDC listings: 299
Live patents: 7
Countries: 1
Base: United States

Authorisation

Registered operations

Analytical testing1Labelling1Finished drug manufacture1Packaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
ANI Pharmaceuticals, Inc.	210 Main Street West, Baudette, Minnesota (MN) 56623, United States (USA)	Analytical testing, Labelling, Finished drug manufacture, Packaging	2111358148515737

Catalogue

Drug listings by form and route

299

299 active NDC listings: 298 human prescription drug, 1 human otc drug. By marketing category: ANDA 219, NDA 40, NDA AUTHORIZED GENERIC 28, UNAPPROVED DRUG OTHER 12.

Dosage form	NDCs
tablet	129
capsule	41
capsule, extended release	24
tablet, film coated	20
solution	17
suspension	11
tablet, extended release	8
tablet, coated	6
gel	5
cream	4
powder, for suspension	4
capsule, delayed release	3
enema	3
granule, for suspension	3
injection	3

Route	NDCs
oral	275
topical	14
rectal	4
intramuscular	2
intravitreal	2
subcutaneous	2
sublingual	1

Labeller name on the listing	NDCs
ani pharmaceuticals, inc.	299

Exclusivity

Patents and exclusivities

Patent	Product	Covers	Expiry
11975047	PURIFIED CORTROPHIN GELcorticotropin	use	Oct 2043
12102662	PURIFIED CORTROPHIN GELcorticotropin	use	Oct 2043
12233105	PURIFIED CORTROPHIN GELcorticotropin	use	Oct 2043
12324787	PURIFIED CORTROPHIN GELcorticotropin	product	Oct 2043
12440542	PURIFIED CORTROPHIN GELcorticotropin	product	Oct 2043

Catalogue

Marketed products

299

Showing 150 of 299.

Brand	Generic name	Form / route	NDC
ARIMIDEX	Anastrozole	tablet, oral	62559-670NDA
ATACAND	Candesartan Cilexetil	tablet, oral	62559-640NDA
ATACAND	Candesartan Cilexetil	tablet, oral	62559-641NDA
ATACAND	Candesartan Cilexetil	tablet, oral	62559-642NDA
ATACAND	Candesartan Cilexetil	tablet, oral	62559-643NDA
ATACAND HCT	Candesartan Cilexetil and Hydrochlorothiazide	tablet, oral	62559-650NDA
ATACAND HCT	Candesartan Cilexetil and Hydrochlorothiazide	tablet, oral	62559-651NDA
ATACAND HCT	Candesartan Cilexetil and Hydrochlorothiazide	tablet, oral	62559-652NDA
Acebutolol Hydrochloride	Acebutolol Hydrochloride	capsule, oral	62559-255ANDA
Acebutolol Hydrochloride	Acebutolol Hydrochloride	capsule, oral	62559-256ANDA
Acetazolamide	Acetazolamide	tablet, oral	70954-033ANDA
Acetazolamide	Acetazolamide	tablet, oral	70954-034ANDA
Alendronate Sodium	Alendronate Sodium	solution, oral	70954-264ANDA
Alprazolam	Alprazolam	tablet, oral	70954-508ANDA
Alprazolam	Alprazolam	tablet, oral	70954-509ANDA
Alprazolam	Alprazolam	tablet, oral	70954-510ANDA
Alprazolam	Alprazolam	tablet, oral	70954-511ANDA
Anagrelide	Anagrelide	capsule, oral	70954-879ANDA
Anagrelide	Anagrelide	capsule, oral	70954-881ANDA
Atenolol and Chlorthalidone	Atenolol and Chlorthalidone	tablet, oral	70954-390ANDA
Atenolol and Chlorthalidone	Atenolol and Chlorthalidone	tablet, oral	70954-391ANDA
Baclofen	Baclofen	suspension, oral	62559-204ANDA
Benazepril Hydrochloride	Benazepril Hydrochloride	tablet, oral	62559-524ANDA
Benazepril Hydrochloride	Benazepril Hydrochloride	tablet, oral	62559-525ANDA
Benazepril Hydrochloride	Benazepril Hydrochloride	tablet, oral	62559-526ANDA
Benazepril Hydrochloride	Benazepril Hydrochloride	tablet, oral	62559-527ANDA
Benazepril Hydrochloride and Hydrochlorothiazide	Benazepril Hydrochloride and Hydrochlorothiazide	tablet, oral	62559-414ANDA
Benazepril Hydrochloride and Hydrochlorothiazide	Benazepril Hydrochloride and Hydrochlorothiazide	tablet, oral	62559-415ANDA
Benazepril Hydrochloride and Hydrochlorothiazide	Benazepril Hydrochloride and Hydrochlorothiazide	tablet, oral	62559-416ANDA
Benazepril Hydrochloride and Hydrochlorothiazide	Benazepril Hydrochloride and Hydrochlorothiazide	tablet, oral	62559-417ANDA
Bexarotene	Bexarotene	capsule, liquid filled, oral	43975-315ANDA
Bicalutamide	Bicalutamide	tablet, oral	62559-890NDA
Bisoprolol Fumarate and Hydrochlorothiazide	Bisoprolol Fumarate and Hydrochlorothiazide	tablet, oral	70954-412ANDA
Bisoprolol Fumarate and Hydrochlorothiazide	Bisoprolol Fumarate and Hydrochlorothiazide	tablet, oral	70954-413ANDA
Bisoprolol Fumarate and Hydrochlorothiazide	Bisoprolol Fumarate and Hydrochlorothiazide	tablet, oral	70954-414ANDA
Bromocriptine Mesylate	Bromocriptine Mesylate	capsule, oral	70954-951NDA
Bromocriptine Mesylate	Bromocriptine Mesylate	tablet, oral	70954-978NDA
CASODEX	Bicalutamide	tablet, oral	62559-680NDA
COLESTIPOL HYDROCHLORIDE	COLESTIPOL HYDROCHLORIDE	tablet, film coated, oral	62559-395ANDA
Calcitriol	Calcitriol	solution, oral	70954-831NDA
Candesartan Cilexetil and Hydrochlorothiazide	Candesartan Cilexetil and Hydrochlorothiazide	tablet, oral	62559-660NDA AUTHORIZED GENERIC
Candesartan Cilexetil and Hydrochlorothiazide	Candesartan Cilexetil and Hydrochlorothiazide	tablet, oral	62559-661NDA AUTHORIZED GENERIC
Candesartan Cilexetil and Hydrochlorothiazide	Candesartan Cilexetil and Hydrochlorothiazide	tablet, oral	62559-662NDA AUTHORIZED GENERIC
Candesartan cilexetil	Candesartan cilexetil	tablet, oral	62559-686NDA AUTHORIZED GENERIC
Candesartan cilexetil	Candesartan cilexetil	tablet, oral	62559-687NDA AUTHORIZED GENERIC
Candesartan cilexetil	Candesartan cilexetil	tablet, oral	62559-688NDA AUTHORIZED GENERIC
Candesartan cilexetil	Candesartan cilexetil	tablet, oral	62559-689NDA AUTHORIZED GENERIC
Carbamazepine	carbamazepine	capsule, extended release, oral	62559-484ANDA
Carbamazepine	carbamazepine	capsule, extended release, oral	62559-485ANDA
Carbamazepine	carbamazepine	capsule, extended release, oral	62559-486ANDA
Carbamazepine	Carbamazepine	suspension, oral	70954-240ANDA
Carboprost Tromethamine	Carboprost Tromethamine	injection, intramuscular	62559-900ANDA
Clomiphene citrate	Clomiphene citrate	tablet, oral	70954-825ANDA
Clorazepate Dipotassium	Clorazepate Dipotassium	tablet, oral	70954-157ANDA
Clorazepate Dipotassium	Clorazepate Dipotassium	tablet, oral	70954-158ANDA
Clorazepate Dipotassium	Clorazepate Dipotassium	tablet, oral	70954-159ANDA
Cortenema	Hydrocortisone	enema, rectal	62559-111NDA
DAPSONE	Dapsone	tablet, oral	70954-135ANDA
DAPSONE	Dapsone	tablet, oral	70954-136ANDA
Dapagliflozin	Dapagliflozin	tablet, film coated, oral	70954-856ANDA
Dapagliflozin	Dapagliflozin	tablet, film coated, oral	70954-857ANDA
Dexamethasone	Dexamethasone	tablet, oral	70954-398ANDA
Dexamethasone	Dexamethasone	tablet, oral	70954-399ANDA
Dexamethasone	Dexamethasone	tablet, oral	70954-401ANDA
Dexamethasone	Dexamethasone	tablet, oral	70954-402ANDA
Dexamethasone	Dexamethasone	tablet, oral	70954-403ANDA
Dexamethasone	Dexamethasone	tablet, oral	70954-404ANDA
Dexamethasone	Dexamethasone	elixir, oral	70954-872ANDA
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate	Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate	capsule, extended release, oral	43975-277ANDA
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate	Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate	capsule, extended release, oral	43975-278ANDA
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate	Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate	capsule, extended release, oral	43975-279ANDA
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate	Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate	capsule, extended release, oral	43975-280ANDA
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate	Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate	capsule, extended release, oral	43975-281ANDA
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate	Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate	capsule, extended release, oral	43975-282ANDA
Digoxin	Digoxin	tablet, oral	70954-200ANDA
Digoxin	Digoxin	tablet, oral	70954-201ANDA
Digoxin	Digoxin	tablet, oral	70954-202ANDA
Diphenoxylate Hydrochloride and Atropine Sulfate	Diphenoxylate Hydrochloride and Atropine Sulfate	tablet, oral	62559-490ANDA
Duloxetine	Duloxetine	capsule, delayed release, oral	70954-860ANDA
Duloxetine	Duloxetine	capsule, delayed release, oral	70954-861ANDA
Duloxetine	Duloxetine	capsule, delayed release, oral	70954-864ANDA
Erythromycin Ethylsuccinate	Erythromycin Ethylsuccinate	granule, for suspension, oral	62559-440ANDA
Erythromycin Ethylsuccinate	Erythromycin Ethylsuccinate	granule, for suspension, oral	62559-630ANDA
Erythromycin Ethylsuccinate	Erythromycin Ethylsuccinate	granule, for suspension, oral	62559-631ANDA
Esterified Estrogens and Methyltestosterone	Esterified Estrogens and Methyltestosterone	tablet, oral	62559-149UNAPPROVED DRUG OTHER
Esterified Estrogens and Methyltestosterone	Esterified Estrogens and Methyltestosterone	tablet, oral	62559-150UNAPPROVED DRUG OTHER
Estradiol	Estradiol	gel, topical	70954-530ANDA
Estradiol	Estradiol	gel, topical	70954-531ANDA
Estradiol	Estradiol	gel, topical	70954-532ANDA
Estradiol	Estradiol	gel, topical	70954-533ANDA
Estradiol	Estradiol	gel, topical	70954-534ANDA
Estradiol	Estradiol	tablet, oral	70954-564ANDA
Estradiol	Estradiol	tablet, oral	70954-565ANDA
Estradiol	Estradiol	tablet, oral	70954-566ANDA
Estradiol	Estradiol	gel, metered, topical	70954-646ANDA
Etodolac	Etodolac	capsule, oral	62559-250ANDA
Etodolac	Etodolac	capsule, oral	62559-251ANDA
Famotidine	Famotidine	powder, for suspension, oral	70954-316ANDA
Felbamate	Felbamate	tablet, oral	62559-730ANDA
Felbamate	Felbamate	tablet, oral	62559-731ANDA
Fenofibrate	Fenofibrate	capsule, oral	43975-305ANDA
Fenofibrate	Fenofibrate	capsule, oral	43975-306ANDA
Fenofibrate	Fenofibrate	capsule, oral	43975-444ANDA
Fenofibrate	fenofibrate	capsule, oral	62559-460NDA AUTHORIZED GENERIC
Fenofibrate	fenofibrate	capsule, oral	62559-461NDA AUTHORIZED GENERIC
Flecainide Acetate	Flecainide Acetate Tablet	tablet, oral	62559-380ANDA
Flecainide Acetate	Flecainide Acetate Tablet	tablet, oral	62559-381ANDA
Flecainide Acetate	Flecainide Acetate Tablet	tablet, oral	62559-382ANDA
Fluconazole	Fluconazole	tablet, oral	62559-990ANDA
Fluconazole	Fluconazole	tablet, oral	62559-991ANDA
Fluconazole	Fluconazole	tablet, oral	62559-992ANDA
Fluconazole	Fluconazole	tablet, oral	62559-993ANDA
Fluocinolone Acetonide	Fluocinolone Acetonide	ointment, topical	62559-299NDA AUTHORIZED GENERIC
Fluoxetine Hydrochloride	Fluoxetine Hydrochloride	solution, oral	70954-600ANDA
Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	tablet, oral	70954-273ANDA
Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	tablet, oral	70954-274ANDA
Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	tablet, oral	70954-275ANDA
Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	tablet, oral	70954-276ANDA
Glipizide	Glipizide	tablet, oral	62559-315ANDA
Glipizide	Glipizide	tablet, oral	62559-316ANDA
Hydrocortisone	Hydrocortisone	enema, rectal	62559-138NDA AUTHORIZED GENERIC
Hydrocortisone	Hydrocortisone	cream, topical	62559-430ANDA
Hydrocortisone	Hydrocortisone	cream, topical	62559-431ANDA
Hydrocortisone	Hydrocortisone	tablet, oral	70954-052ANDA
Hydrocortisone	Hydrocortisone	tablet, oral	70954-053ANDA
Hydrocortisone	Hydrocortisone	tablet, oral	70954-054ANDA
Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride	solution, oral	70954-912ANDA
Hyoscyamine Sulfate	Hyoscyamine Sulfate	tablet, oral	62559-421UNAPPROVED DRUG OTHER
Hyoscyamine Sulfate	Hyoscyamine Sulfate	tablet, orally disintegrating, oral	62559-422UNAPPROVED DRUG OTHER
Hyoscyamine Sulfate	Hyoscyamine Sulfate	tablet, extended release, oral	62559-423UNAPPROVED DRUG OTHER
Hyoscyamine Sulfate	Hyoscyamine Sulfate	tablet, sublingual	62559-424UNAPPROVED DRUG OTHER
INDERAL LA	propranolol hydrochloride	capsule, extended release, oral	62559-520NDA
INDERAL LA	propranolol hydrochloride	capsule, extended release, oral	62559-521NDA
INDERAL LA	propranolol hydrochloride	capsule, extended release, oral	62559-522NDA
INDERAL LA	propranolol hydrochloride	capsule, extended release, oral	62559-523NDA
INZIRQO	hydrochlorothiazide	powder, for suspension, oral	70954-522NDA
Iluvien	fluocinolone acetonide	implant, intravitreal	68611-190NDA
Indapamide	Indapamide	tablet, film coated, oral	62559-510ANDA
Indapamide	Indapamide	tablet, film coated, oral	62559-511ANDA
Inderal XL	propranolol hydrochloride	capsule, extended release, oral	62559-600NDA
Inderal XL	propranolol hydrochloride	capsule, extended release, oral	62559-601NDA
Indomethacin	Indomethacin	suspension, oral	70954-637ANDA
InnoPran XL	propranolol hydrochloride	capsule, extended release, oral	62559-590NDA
InnoPran XL	propranolol hydrochloride	capsule, extended release, oral	62559-591NDA
Isosorbide Mononitrate	Isosorbide Mononitrate	tablet, oral	62559-252ANDA
Isosorbide Mononitrate	Isosorbide Mononitrate	tablet, oral	62559-253ANDA
Ketoconazole	Ketoconazole	shampoo, topical	70954-662ANDA
Kionex	Sodium Polystyrene Sulfonate	suspension, oral	62559-356ANDA
L-Glutamine	L-Glutamine	powder, for solution, oral	70954-417ANDA
LITHOBID	lithium carbonate	tablet, film coated, extended release, oral	62559-280NDA

Neighbours

Registered in the same town

Alimera Sciences, Inc.Baudette, MN

Compare

Comparable companies in United States

Hahnemann Laboratories, Inc. dba Alpine Pharmaceuticals1 site · 4,853 NDC
NuCare Pharmaceuticals,Inc.1 site · 1,393 NDC
Greer Laboratories, Inc.1 site · 1,328 NDC
ASCLEMED USA INC. DBA ENOVACHEM1 site · 789 NDC
Golden State Medical Supply Inc.1 site · 670 NDC
Rising Pharma Holdings, Inc.1 site · 532 NDC
HF Acquisition Co LLC1 site · 363 NDC
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.1 site · 273 NDC
Newton Laboratories, Inc.1 site · 271 NDC
Uriel Pharmacy1 site · 270 NDC

Enquiry

Common questions

Is ANI Pharmaceuticals, Inc. FDA approved?: ANI Pharmaceuticals, Inc. holds 1 FDA-registered establishment in the United States. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
Where are ANI Pharmaceuticals, Inc.'s drugs manufactured?: The FDA register lists Baudette, MN. Registered operations: analytical testing, labelling, finished drug manufacture, packaging.
What drugs does ANI Pharmaceuticals, Inc. make?: 299 products are listed under ANI Pharmaceuticals, Inc. in the openFDA NDC Directory, most often as tablet; capsule; capsule, extended release. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.