Register entry
ANI Pharmaceuticals, Inc.
- Registered sites
- 1
- Drug products
- 299
- Live patents
- 7
- Countries
- 1
- Base
- United States
Authorisation
Registered operations
What the FDA has registered these sites to do. This is the regulatory record, not a marketing claim.
Analytical testingLabellingFinished drug manufacturePackaging
Sites
Facilities
1| Site | Location | Operations | FEI |
|---|---|---|---|
| ANI Pharmaceuticals, Inc. | Baudette, MNUnited States | Analytical testing, Labelling, Finished drug manufacture, Packaging | 2111358 |
Exclusivity
Patents
7Unexpired Orange Book patents where this company is the application holder.
| Product | Active ingredient | Expiry |
|---|---|---|
| PURIFIED CORTROPHIN GEL | CORTICOTROPIN | Oct 2043 |
| VEREGEN | SINECATECHINS | Oct 2026 |
Catalogue
Marketed products
299Showing 150 of 299.
| Brand | Generic name | Form | Category |
|---|---|---|---|
| ARIMIDEX | Anastrozole | TABLET | NDA |
| ATACAND | Candesartan Cilexetil | TABLET | NDA |
| ATACAND | Candesartan Cilexetil | TABLET | NDA |
| ATACAND | Candesartan Cilexetil | TABLET | NDA |
| ATACAND | Candesartan Cilexetil | TABLET | NDA |
| ATACAND HCT | Candesartan Cilexetil and Hydrochlorothiazide | TABLET | NDA |
| ATACAND HCT | Candesartan Cilexetil and Hydrochlorothiazide | TABLET | NDA |
| ATACAND HCT | Candesartan Cilexetil and Hydrochlorothiazide | TABLET | NDA |
| Acebutolol Hydrochloride | Acebutolol Hydrochloride | CAPSULE | ANDA |
| Acebutolol Hydrochloride | Acebutolol Hydrochloride | CAPSULE | ANDA |
| Acetazolamide | Acetazolamide | TABLET | ANDA |
| Acetazolamide | Acetazolamide | TABLET | ANDA |
| Alendronate Sodium | Alendronate Sodium | SOLUTION | ANDA |
| Alprazolam | Alprazolam | TABLET | ANDA |
| Alprazolam | Alprazolam | TABLET | ANDA |
| Alprazolam | Alprazolam | TABLET | ANDA |
| Alprazolam | Alprazolam | TABLET | ANDA |
| Anagrelide | Anagrelide | CAPSULE | ANDA |
| Anagrelide | Anagrelide | CAPSULE | ANDA |
| Atenolol and Chlorthalidone | Atenolol and Chlorthalidone | TABLET | ANDA |
| Atenolol and Chlorthalidone | Atenolol and Chlorthalidone | TABLET | ANDA |
| Baclofen | Baclofen | SUSPENSION | ANDA |
| Benazepril Hydrochloride | Benazepril Hydrochloride | TABLET | ANDA |
| Benazepril Hydrochloride | Benazepril Hydrochloride | TABLET | ANDA |
| Benazepril Hydrochloride | Benazepril Hydrochloride | TABLET | ANDA |
| Benazepril Hydrochloride | Benazepril Hydrochloride | TABLET | ANDA |
| Benazepril Hydrochloride and Hydrochlorothiazide | Benazepril Hydrochloride and Hydrochlorothiazide | TABLET | ANDA |
| Benazepril Hydrochloride and Hydrochlorothiazide | Benazepril Hydrochloride and Hydrochlorothiazide | TABLET | ANDA |
| Benazepril Hydrochloride and Hydrochlorothiazide | Benazepril Hydrochloride and Hydrochlorothiazide | TABLET | ANDA |
| Benazepril Hydrochloride and Hydrochlorothiazide | Benazepril Hydrochloride and Hydrochlorothiazide | TABLET | ANDA |
| Bexarotene | Bexarotene | CAPSULE, LIQUID FILLED | ANDA |
| Bicalutamide | Bicalutamide | TABLET | NDA |
| Bisoprolol Fumarate and Hydrochlorothiazide | Bisoprolol Fumarate and Hydrochlorothiazide | TABLET | ANDA |
| Bisoprolol Fumarate and Hydrochlorothiazide | Bisoprolol Fumarate and Hydrochlorothiazide | TABLET | ANDA |
| Bisoprolol Fumarate and Hydrochlorothiazide | Bisoprolol Fumarate and Hydrochlorothiazide | TABLET | ANDA |
| Bromocriptine Mesylate | Bromocriptine Mesylate | CAPSULE | NDA |
| Bromocriptine Mesylate | Bromocriptine Mesylate | TABLET | NDA |
| CASODEX | Bicalutamide | TABLET | NDA |
| COLESTIPOL HYDROCHLORIDE | COLESTIPOL HYDROCHLORIDE | TABLET, FILM COATED | ANDA |
| Calcitriol | Calcitriol | SOLUTION | NDA |
| Candesartan Cilexetil and Hydrochlorothiazide | Candesartan Cilexetil and Hydrochlorothiazide | TABLET | NDA AUTHORIZED GENERIC |
| Candesartan Cilexetil and Hydrochlorothiazide | Candesartan Cilexetil and Hydrochlorothiazide | TABLET | NDA AUTHORIZED GENERIC |
| Candesartan Cilexetil and Hydrochlorothiazide | Candesartan Cilexetil and Hydrochlorothiazide | TABLET | NDA AUTHORIZED GENERIC |
| Candesartan cilexetil | Candesartan cilexetil | TABLET | NDA AUTHORIZED GENERIC |
| Candesartan cilexetil | Candesartan cilexetil | TABLET | NDA AUTHORIZED GENERIC |
| Candesartan cilexetil | Candesartan cilexetil | TABLET | NDA AUTHORIZED GENERIC |
| Candesartan cilexetil | Candesartan cilexetil | TABLET | NDA AUTHORIZED GENERIC |
| Carbamazepine | carbamazepine | CAPSULE, EXTENDED RELEASE | ANDA |
| Carbamazepine | carbamazepine | CAPSULE, EXTENDED RELEASE | ANDA |
| Carbamazepine | carbamazepine | CAPSULE, EXTENDED RELEASE | ANDA |
| Carbamazepine | Carbamazepine | SUSPENSION | ANDA |
| Carboprost Tromethamine | Carboprost Tromethamine | INJECTION | ANDA |
| Clomiphene citrate | Clomiphene citrate | TABLET | ANDA |
| Clorazepate Dipotassium | Clorazepate Dipotassium | TABLET | ANDA |
| Clorazepate Dipotassium | Clorazepate Dipotassium | TABLET | ANDA |
| Clorazepate Dipotassium | Clorazepate Dipotassium | TABLET | ANDA |
| Cortenema | Hydrocortisone | ENEMA | NDA |
| DAPSONE | Dapsone | TABLET | ANDA |
| DAPSONE | Dapsone | TABLET | ANDA |
| Dapagliflozin | Dapagliflozin | TABLET, FILM COATED | ANDA |
| Dapagliflozin | Dapagliflozin | TABLET, FILM COATED | ANDA |
| Dexamethasone | Dexamethasone | TABLET | ANDA |
| Dexamethasone | Dexamethasone | TABLET | ANDA |
| Dexamethasone | Dexamethasone | TABLET | ANDA |
| Dexamethasone | Dexamethasone | TABLET | ANDA |
| Dexamethasone | Dexamethasone | TABLET | ANDA |
| Dexamethasone | Dexamethasone | TABLET | ANDA |
| Dexamethasone | Dexamethasone | ELIXIR | ANDA |
| Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate | CAPSULE, EXTENDED RELEASE | ANDA |
| Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate | CAPSULE, EXTENDED RELEASE | ANDA |
| Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate | CAPSULE, EXTENDED RELEASE | ANDA |
| Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate | CAPSULE, EXTENDED RELEASE | ANDA |
| Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate | CAPSULE, EXTENDED RELEASE | ANDA |
| Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate | CAPSULE, EXTENDED RELEASE | ANDA |
| Digoxin | Digoxin | TABLET | ANDA |
| Digoxin | Digoxin | TABLET | ANDA |
| Digoxin | Digoxin | TABLET | ANDA |
| Diphenoxylate Hydrochloride and Atropine Sulfate | Diphenoxylate Hydrochloride and Atropine Sulfate | TABLET | ANDA |
| Duloxetine | Duloxetine | CAPSULE, DELAYED RELEASE | ANDA |
| Duloxetine | Duloxetine | CAPSULE, DELAYED RELEASE | ANDA |
| Duloxetine | Duloxetine | CAPSULE, DELAYED RELEASE | ANDA |
| Erythromycin Ethylsuccinate | Erythromycin Ethylsuccinate | GRANULE, FOR SUSPENSION | ANDA |
| Erythromycin Ethylsuccinate | Erythromycin Ethylsuccinate | GRANULE, FOR SUSPENSION | ANDA |
| Erythromycin Ethylsuccinate | Erythromycin Ethylsuccinate | GRANULE, FOR SUSPENSION | ANDA |
| Esterified Estrogens and Methyltestosterone | Esterified Estrogens and Methyltestosterone | TABLET | UNAPPROVED DRUG OTHER |
| Esterified Estrogens and Methyltestosterone | Esterified Estrogens and Methyltestosterone | TABLET | UNAPPROVED DRUG OTHER |
| Estradiol | Estradiol | GEL | ANDA |
| Estradiol | Estradiol | GEL | ANDA |
| Estradiol | Estradiol | GEL | ANDA |
| Estradiol | Estradiol | GEL | ANDA |
| Estradiol | Estradiol | GEL | ANDA |
| Estradiol | Estradiol | TABLET | ANDA |
| Estradiol | Estradiol | TABLET | ANDA |
| Estradiol | Estradiol | TABLET | ANDA |
| Estradiol | Estradiol | GEL, METERED | ANDA |
| Etodolac | Etodolac | CAPSULE | ANDA |
| Etodolac | Etodolac | CAPSULE | ANDA |
| Famotidine | Famotidine | POWDER, FOR SUSPENSION | ANDA |
| Felbamate | Felbamate | TABLET | ANDA |
| Felbamate | Felbamate | TABLET | ANDA |
| Fenofibrate | Fenofibrate | CAPSULE | ANDA |
| Fenofibrate | Fenofibrate | CAPSULE | ANDA |
| Fenofibrate | Fenofibrate | CAPSULE | ANDA |
| Fenofibrate | fenofibrate | CAPSULE | NDA AUTHORIZED GENERIC |
| Fenofibrate | fenofibrate | CAPSULE | NDA AUTHORIZED GENERIC |
| Flecainide Acetate | Flecainide Acetate Tablet | TABLET | ANDA |
| Flecainide Acetate | Flecainide Acetate Tablet | TABLET | ANDA |
| Flecainide Acetate | Flecainide Acetate Tablet | TABLET | ANDA |
| Fluconazole | Fluconazole | TABLET | ANDA |
| Fluconazole | Fluconazole | TABLET | ANDA |
| Fluconazole | Fluconazole | TABLET | ANDA |
| Fluconazole | Fluconazole | TABLET | ANDA |
| Fluocinolone Acetonide | Fluocinolone Acetonide | OINTMENT | NDA AUTHORIZED GENERIC |
| Fluoxetine Hydrochloride | Fluoxetine Hydrochloride | SOLUTION | ANDA |
| Fluphenazine Hydrochloride | Fluphenazine Hydrochloride | TABLET | ANDA |
| Fluphenazine Hydrochloride | Fluphenazine Hydrochloride | TABLET | ANDA |
| Fluphenazine Hydrochloride | Fluphenazine Hydrochloride | TABLET | ANDA |
| Fluphenazine Hydrochloride | Fluphenazine Hydrochloride | TABLET | ANDA |
| Glipizide | Glipizide | TABLET | ANDA |
| Glipizide | Glipizide | TABLET | ANDA |
| Hydrocortisone | Hydrocortisone | ENEMA | NDA AUTHORIZED GENERIC |
| Hydrocortisone | Hydrocortisone | CREAM | ANDA |
| Hydrocortisone | Hydrocortisone | CREAM | ANDA |
| Hydrocortisone | Hydrocortisone | TABLET | ANDA |
| Hydrocortisone | Hydrocortisone | TABLET | ANDA |
| Hydrocortisone | Hydrocortisone | TABLET | ANDA |
| Hydroxyzine Hydrochloride | Hydroxyzine Hydrochloride | SOLUTION | ANDA |
| Hyoscyamine Sulfate | Hyoscyamine Sulfate | TABLET | UNAPPROVED DRUG OTHER |
| Hyoscyamine Sulfate | Hyoscyamine Sulfate | TABLET, ORALLY DISINTEGRATING | UNAPPROVED DRUG OTHER |
| Hyoscyamine Sulfate | Hyoscyamine Sulfate | TABLET, EXTENDED RELEASE | UNAPPROVED DRUG OTHER |
| Hyoscyamine Sulfate | Hyoscyamine Sulfate | TABLET | UNAPPROVED DRUG OTHER |
| INDERAL LA | propranolol hydrochloride | CAPSULE, EXTENDED RELEASE | NDA |
| INDERAL LA | propranolol hydrochloride | CAPSULE, EXTENDED RELEASE | NDA |
| INDERAL LA | propranolol hydrochloride | CAPSULE, EXTENDED RELEASE | NDA |
| INDERAL LA | propranolol hydrochloride | CAPSULE, EXTENDED RELEASE | NDA |
| INZIRQO | hydrochlorothiazide | POWDER, FOR SUSPENSION | NDA |
| Iluvien | fluocinolone acetonide | IMPLANT | NDA |
| Indapamide | Indapamide | TABLET, FILM COATED | ANDA |
| Indapamide | Indapamide | TABLET, FILM COATED | ANDA |
| Inderal XL | propranolol hydrochloride | CAPSULE, EXTENDED RELEASE | NDA |
| Inderal XL | propranolol hydrochloride | CAPSULE, EXTENDED RELEASE | NDA |
| Indomethacin | Indomethacin | SUSPENSION | ANDA |
| InnoPran XL | propranolol hydrochloride | CAPSULE, EXTENDED RELEASE | NDA |
| InnoPran XL | propranolol hydrochloride | CAPSULE, EXTENDED RELEASE | NDA |
| Isosorbide Mononitrate | Isosorbide Mononitrate | TABLET | ANDA |
| Isosorbide Mononitrate | Isosorbide Mononitrate | TABLET | ANDA |
| Ketoconazole | Ketoconazole | SHAMPOO | ANDA |
| Kionex | Sodium Polystyrene Sulfonate | SUSPENSION | ANDA |
| L-Glutamine | L-Glutamine | POWDER, FOR SOLUTION | ANDA |
| LITHOBID | lithium carbonate | TABLET, FILM COATED, EXTENDED RELEASE | NDA |
Provenance
Facility and operations data from the FDA Drug Establishments Current Registration Site. Product data from the openFDA National Drug Code Directory. Patent and exclusivity data from the FDA Orange Book. Shortage data from the FDA drug shortage database. Contact details the FDA publishes for registered establishments are deliberately not reproduced here. This entry is compiled from public records and has not been claimed by the company.