Register entry
Glenmark Pharmaceuticals Inc., USA
- Registered sites
- 9
- Drug products
- 382
- Live patents
- 17
- Countries
- 3
- Base
- India
Authorisation
Registered operations
What the FDA has registered these sites to do. This is the regulatory record, not a marketing claim.
Analytical testingActive ingredient (API) manufactureLabellingFinished drug manufacturePackagingsterilize
Sites
Facilities
9| Site | Location | Operations | FEI |
|---|---|---|---|
| Glenmark Generics S.A. | PilarArgentina | Analytical testing, Labelling, Finished drug manufacture, Packaging | 3009805225 |
| Alivus Life Sciences Limited | AnkleshwarIndia | Analytical testing, Active ingredient (API) manufacture, Labelling | 3004006229 |
| Alivus Life Sciences Limited | BharuchIndia | Analytical testing, Active ingredient (API) manufacture, Labelling | 3007514214 |
| Glenmark Pharmaceuticals Limited | Chhatrapati Sambhajinagar (previously known as Aurangabad)India | Analytical testing, Labelling, Finished drug manufacture, Packaging | 3009915929 |
| Glenmark Pharmaceuticals Limited | DharIndia | Analytical testing, Labelling, Finished drug manufacture, Packaging | 3008565058 |
| Glenmark Pharmaceuticals Limited | GoaIndia | Analytical testing, Labelling, Finished drug manufacture, Packaging | 3004672766 |
| Glenmark Pharmaceuticals Limited | SolanIndia | Analytical testing, Labelling, Finished drug manufacture, Packaging | 3005757050 |
| Alivus Life Sciences Limited | SolapurIndia | Active ingredient (API) manufacture | 3014026060 |
| Glenmark Pharmaceuticals Inc., USA | Monroe, NCUnited States | Analytical testing, Labelling, Finished drug manufacture, Packaging, sterilize | 3011585599 |
Exclusivity
Patents
17Unexpired Orange Book patents where this company is the application holder.
| Product | Active ingredient | Expiry |
|---|---|---|
| RYALTRIS | MOMETASONE FUROATE; OLOPATADINE HYDROCHLORIDE | Sept 2034 |
| RYALTRIS | MOMETASONE FUROATE; OLOPATADINE HYDROCHLORIDE | Sept 2038 |
| RYALTRIS | MOMETASONE FUROATE; OLOPATADINE HYDROCHLORIDE | Apr 2039 |
| RYALTRIS | MOMETASONE FUROATE; OLOPATADINE HYDROCHLORIDE | Nov 2044 |
Catalogue
Marketed products
382Showing 150 of 382.
| Brand | Generic name | Form | Category |
|---|---|---|---|
| ALYACEN 1/35 | norethindrone and ethinyl estradiol | KIT | ANDA |
| ALYACEN 7/7/7 | norethindrone and ethinyl estradiol | KIT | ANDA |
| ASPRIN AND EXTENDED-RELEASE DIPYRIDAMOLE | ASPRIN AND EXTENDED-RELEASE DIPYRIDAMOLE | CAPSULE | ANDA |
| Acamprosate Calcium | Acamprosate Calcium | TABLET, DELAYED RELEASE | ANDA |
| Acetaminophen, Ibuprofen | Acetaminophen, Ibuprofen | TABLET, FILM COATED | ANDA |
| Acetylcysteine | Acetylcysteine | INJECTION, SOLUTION | ANDA |
| Adapalene | Adapalene | GEL | ANDA |
| Alclometasone Dipropionate | Alclometasone Dipropionate | OINTMENT | ANDA |
| Amlodipine and Olmesartan Medoxomil | Amlodipine and Olmesartan Medoxomil | TABLET, FILM COATED | ANDA |
| Amlodipine and Olmesartan Medoxomil | Amlodipine and Olmesartan Medoxomil | TABLET, FILM COATED | ANDA |
| Amlodipine and Olmesartan Medoxomil | Amlodipine and Olmesartan Medoxomil | TABLET, FILM COATED | ANDA |
| Amlodipine and Olmesartan Medoxomil | Amlodipine and Olmesartan Medoxomil | TABLET, FILM COATED | ANDA |
| Aprepitant | Aprepitant | KIT | ANDA |
| Aprepitant | Aprepitant | CAPSULE | ANDA |
| Aprepitant | Aprepitant | CAPSULE | ANDA |
| Aprepitant | Aprepitant | CAPSULE | ANDA |
| Ashlyna | Levonorgestrel and Ethinyl Estradiol and Ethinyl Estradiol | KIT | ANDA |
| Atovaquone and Proguanil Hydrochloride | Atovaquone and Proguanil Hydrochloride | TABLET, FILM COATED | ANDA |
| Atovaquone and Proguanil Hydrochloride Pediatric | Atovaquone and Proguanil Hydrochloride Pediatric | TABLET, FILM COATED | ANDA |
| Azathioprine | Azathioprine | TABLET | ANDA |
| BRIELLYN | Norethindrone and Ethinyl Estradiol | KIT | ANDA |
| Benazepril Hydrochloride and Hydrochlorothiazide | Benazepril Hydrochloride and Hydrochlorothiazide | TABLET, FILM COATED | ANDA |
| Benazepril Hydrochloride and Hydrochlorothiazide | Benazepril Hydrochloride and Hydrochlorothiazide | TABLET, FILM COATED | ANDA |
| Benazepril Hydrochloride and Hydrochlorothiazide | Benazepril Hydrochloride and Hydrochlorothiazide | TABLET, FILM COATED | ANDA |
| Benazepril Hydrochloride and Hydrochlorothiazide | Benazepril Hydrochloride and Hydrochlorothiazide | TABLET, FILM COATED | ANDA |
| Betamethasone Dipropionate | Betamethasone Dipropionate | CREAM | ANDA |
| Bisoprolol Fumarate and Hydrochlorothiazide | Bisoprolol Fumarate and Hydrochlorothiazide | TABLET, FILM COATED | ANDA |
| Bisoprolol Fumarate and Hydrochlorothiazide | Bisoprolol Fumarate and Hydrochlorothiazide | TABLET, FILM COATED | ANDA |
| Bisoprolol Fumarate and Hydrochlorothiazide | Bisoprolol Fumarate and Hydrochlorothiazide | TABLET, FILM COATED | ANDA |
| Brimonidine Tartrate/Timolol Maleate | Brimonidine Tartrate and Timolol Maleate | SOLUTION/ DROPS | ANDA |
| Bumetanide | Bumetanide | INJECTION | ANDA |
| Bumetanide | Bumetanide | INJECTION | ANDA |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | SPRAY | ANDA |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | SOLUTION | ANDA |
| Calcipotriene | Calcipotriene | OINTMENT | ANDA |
| Calcium Gluconate | Calcium Gluconate | INJECTION, SOLUTION | ANDA |
| Calcium Gluconate | Calcium Gluconate | INJECTION, SOLUTION | ANDA |
| Calcium Gluconate | Calcium Gluconate | INJECTION, SOLUTION | ANDA |
| Carvedilol | Carvedilol | TABLET, FILM COATED | ANDA |
| Carvedilol | Carvedilol | TABLET, FILM COATED | ANDA |
| Carvedilol | Carvedilol | TABLET, FILM COATED | ANDA |
| Carvedilol | Carvedilol | TABLET, FILM COATED | ANDA |
| Cetirizine HCl | Cetirizine | TABLET | ANDA |
| Cetirizine HCl | Cetirizine | TABLET | ANDA |
| Cetirizine HCl | Cetirizine | KIT | ANDA |
| Cetirizine HCl | Cetirizine | KIT | ANDA |
| Charlotte 24Fe | norethindrone acetate and ethinyl estradiol and ferrous fumarate | KIT | ANDA |
| Childrens Fluticasone Propionate ALLERGY RELIEF | fluticasone propionate | SPRAY, METERED | ANDA |
| Chlorpromazine Hydrochloride | Chlorpromazine Hydrochloride | TABLET, FILM COATED | ANDA |
| Chlorpromazine Hydrochloride | Chlorpromazine Hydrochloride | TABLET, FILM COATED | ANDA |
| Chlorpromazine Hydrochloride | Chlorpromazine Hydrochloride | TABLET, FILM COATED | ANDA |
| Chlorpromazine Hydrochloride | Chlorpromazine Hydrochloride | TABLET, FILM COATED | ANDA |
| Chlorpromazine Hydrochloride | Chlorpromazine Hydrochloride | TABLET, FILM COATED | ANDA |
| Ciclopirox Olamine | Ciclopirox Olamine | CREAM | ANDA |
| Citalopram Hydrobromide | Citalopram Hydrobromide | TABLET, FILM COATED | ANDA |
| Citalopram Hydrobromide | Citalopram Hydrobromide | TABLET, FILM COATED | ANDA |
| Citalopram Hydrobromide | Citalopram Hydrobromide | TABLET, FILM COATED | ANDA |
| Clindamycin Hydrochloride | Clindamycin Hydrochloride | CAPSULE | ANDA |
| Clindamycin Hydrochloride | Clindamycin Hydrochloride | CAPSULE | ANDA |
| Clindamycin Hydrochloride | Clindamycin Hydrochloride | CAPSULE | ANDA |
| Clindamycin Phosphate | Clindamycin Phosphate | AEROSOL, FOAM | ANDA |
| Clindamycin Phosphate | Clindamycin Phosphate | GEL | ANDA |
| Clobetasol Propionate | Clobetasol Propionate | OINTMENT | ANDA |
| Clobetasol Propionate | clobetasol propionate | AEROSOL, FOAM | ANDA |
| Clotrimazole | Clotrimazole | CREAM | ANDA |
| Clotrimazole and Betamethasone Dipropionate | Clotrimazole and Betamethasone Dipropionate | CREAM | ANDA |
| Colesevelam Hydrochloride | Colesevelam Hydrochloride | POWDER, FOR SUSPENSION | ANDA |
| DICLOFENAC SODIUM | diclofenac sodium | GEL | ANDA |
| DIMETHYL FUMARATE | dimethyl-fumarate | CAPSULE | ANDA |
| DIMETHYL FUMARATE | dimethyl-fumarate | CAPSULE | ANDA |
| DIMETHYL FUMARATE | dimethyl fumarate kit | KIT | ANDA |
| Desmopressin Acetate | Desmopressin Acetate | TABLET | ANDA |
| Desmopressin Acetate | Desmopressin Acetate | TABLET | ANDA |
| Desoximetasone | Desoximetasone | OINTMENT | ANDA |
| Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate | TABLET | ANDA |
| Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate | TABLET | ANDA |
| Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate | TABLET | ANDA |
| Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate | TABLET | ANDA |
| Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate | TABLET | ANDA |
| Diltiazem Hydrochloride | Diltiazem Hydrochloride | CAPSULE, EXTENDED RELEASE | ANDA |
| Diltiazem Hydrochloride | Diltiazem Hydrochloride | CAPSULE, EXTENDED RELEASE | ANDA |
| Diltiazem Hydrochloride | Diltiazem Hydrochloride | CAPSULE, EXTENDED RELEASE | ANDA |
| ERIBULIN MESYLATE | eribulin mesylate | INJECTION | ANDA |
| ESTRADIOL VAGINAL INSERTS | estradiol | TABLET, FILM COATED | ANDA |
| Esomeprazole Magnesium | Esomeprazole Magnesium | CAPSULE, DELAYED RELEASE PELLETS | ANDA |
| Esomeprazole Magnesium | Esomeprazole Magnesium | CAPSULE, DELAYED RELEASE PELLETS | ANDA |
| Eszopiclone | Eszopiclone | TABLET, FILM COATED | ANDA |
| Eszopiclone | Eszopiclone | TABLET, FILM COATED | ANDA |
| Eszopiclone | Eszopiclone | TABLET, FILM COATED | ANDA |
| Ezetimibe | Ezetimibe | TABLET | ANDA |
| FLUOCINOLONE ACETONIDE | fluocinolone acetonide | OIL | ANDA |
| FLUTICASONE PROPIONATE | fluticasone propionate | AEROSOL, METERED | ANDA |
| Famotidine | Famotidine | TABLET, FILM COATED | ANDA |
| Famotidine | Famotidine | TABLET, FILM COATED | ANDA |
| Famotidine | Famotidine | TABLET, FILM COATED | ANDA |
| Felodipine | Felodipine | TABLET, FILM COATED, EXTENDED RELEASE | ANDA |
| Felodipine | Felodipine | TABLET, FILM COATED, EXTENDED RELEASE | ANDA |
| Felodipine | Felodipine | TABLET, FILM COATED, EXTENDED RELEASE | ANDA |
| Fluconazole | Fluconazole | TABLET | ANDA |
| Fluconazole | Fluconazole | TABLET | ANDA |
| Fluconazole | Fluconazole | TABLET | ANDA |
| Fluconazole | Fluconazole | TABLET | ANDA |
| Fluocinonide | Fluocinonide | CREAM | ANDA |
| Fluphenazine Hydrochloride | Fluphenazine Hydrochloride | TABLET, FILM COATED | ANDA |
| Fluphenazine Hydrochloride | Fluphenazine Hydrochloride | TABLET, FILM COATED | ANDA |
| Fluphenazine Hydrochloride | Fluphenazine Hydrochloride | TABLET, FILM COATED | ANDA |
| Fluphenazine Hydrochloride | Fluphenazine Hydrochloride | TABLET, FILM COATED | ANDA |
| Fluticasone Propionate | Fluticasone Propionate | LOTION | ANDA |
| Fluticasone Propionate ALLERGY RELIEF | fluticasone propionate | SPRAY, METERED | ANDA |
| Fosphenytoin sodium | Fosphenytoin sodium | INJECTION, SOLUTION | ANDA |
| Fosphenytoin sodium | Fosphenytoin sodium | INJECTION, SOLUTION | ANDA |
| Fosphenytoin sodium | Fosphenytoin sodium | INJECTION, SOLUTION | ANDA |
| Fulvestrant | Fulvestrant | INJECTION | ANDA |
| Gabapentin | Gabapentin | TABLET | ANDA |
| Gabapentin | Gabapentin | TABLET | ANDA |
| HAILEY Fe 1/20 | norethindrone acetate and ethinyl estradiol and ferrous fumarate | KIT | ANDA |
| HEATHER | Norethindrone | TABLET | ANDA |
| Hailey 1.5/30 | Norethindrone Acetate and Ethinyl Estradiol | TABLET | ANDA |
| Hailey 24 Fe | norethindrone acetate and ethinyl estradiol, and ferrous fumarate | KIT | ANDA |
| Hailey Fe 1.5/30 | Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate | KIT | ANDA |
| Hydralazine Hydrochloride | Hydralazine Hydrochloride | TABLET | ANDA |
| Hydralazine Hydrochloride | Hydralazine Hydrochloride | TABLET | ANDA |
| Hydralazine Hydrochloride | Hydralazine Hydrochloride | TABLET | ANDA |
| Hydralazine Hydrochloride | Hydralazine Hydrochloride | TABLET | ANDA |
| Hydrocortisone Valerate | HYDROCORTISONE VALERATE | OINTMENT | ANDA |
| Imiquimod | Imiquimod | CREAM | ANDA |
| Indomethacin | Indomethacin | CAPSULE | ANDA |
| Indomethacin | Indomethacin | CAPSULE | ANDA |
| KETOROLAC TROMETHAMINE | ketorolac tromethamine | INJECTION, SOLUTION | ANDA |
| KETOROLAC TROMETHAMINE | ketorolac tromethamine | INJECTION, SOLUTION | ANDA |
| KETOROLAC TROMETHAMINE | ketorolac tromethamine | INJECTION, SOLUTION | ANDA |
| LACOSAMIDE | LACOSAMIDE | INJECTION, SOLUTION | ANDA |
| LEVOCETIRIZINE DIHYDROCHLORIDE | levocetirizine dihydrochloride | TABLET | ANDA |
| Lacosamide | Lacosamide | SOLUTION | ANDA |
| Lamotrigine | Lamotrigine | TABLET, CHEWABLE | ANDA |
| Lamotrigine | Lamotrigine | TABLET, CHEWABLE | ANDA |
| Leucovorin Calcium | Leucovorin Calcium | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | ANDA |
| Levonorgestrel | Levonorgestrel | TABLET | ANDA |
| Levonorgestrel and Ethinyl Estradiol | Levonorgestrel and Ethinyl Estradiol | TABLET | ANDA |
| Lithium Carbonate | Lithium Carbonate | CAPSULE | ANDA |
| Lithium Carbonate | Lithium Carbonate | CAPSULE | ANDA |
| Lithium Carbonate | Lithium Carbonate | CAPSULE | ANDA |
| Lithium Carbonate | Lithium Carbonate | TABLET, FILM COATED, EXTENDED RELEASE | ANDA |
| Lithium Carbonate ER | Lithium Carbonate | TABLET | ANDA |
| MARLISSA | Levonorgestrel and Ethinyl Estradiol | KIT | ANDA |
| METFORMIN HYDROCHLORIDE | metformin hydrochloride | TABLET, FILM COATED, EXTENDED RELEASE | ANDA |
| METFORMIN HYDROCHLORIDE | metformin hydrochloride | TABLET, FILM COATED, EXTENDED RELEASE | ANDA |
| METHYLENE BLUE | METHYLENE BLUE | INJECTION | ANDA |
| MICAFUNGIN | Micafungin | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | ANDA |
| MICAFUNGIN | Micafungin | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | ANDA |
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.