Register entry
- Registered sites
- 7
- Active NDC listings
- 58
- Live patents
- 0
- Countries
- 1
- Base
- India
Authorisation
Registered operations
Analytical testing7Active ingredient (API) manufacture3Labelling5Finished drug manufacture2Packaging5
Sites
Registered establishments
7| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| WARREN REMEDIES PRIVATE LIMITEDRegistrant: Indoco Remedies Limited | Plot No. 17, AURIC Shendra, Sector No. 13, Shendra M.I.D.C., Chhatrapati Sambhajinagar, Maharashtra 431154, India (IND) | Analytical testing, Active ingredient (API) manufacture, Labelling, Packaging | 3034735246929597063 |
| INDOCO REMEDIES LIMITEDRegistrant: Indoco Remedies Limited | Plot No B-19, MIDC, Waluj, Aurangabad Taluka: Gangapur, District: Aurangabad (Chhatrapati Sambhajinagar), Maharashtra 431136, India (IND) | Analytical testing | 3038105724855531249 |
| INDOCO REMEDIES LIMITEDRegistrant: Indoco Remedies Limited | Goa Plant-II & III, L-32,33,34, Verna Industrial Area, Verna, Goa, Goa 403722, India (IND) | Analytical testing, Labelling, Finished drug manufacture, Packaging | 3005124189915851870 |
| INDOCO REMEDIES LIMITEDRegistrant: Indoco Remedies Limited | Goa Plant-I, L-14, Verna Industrial Area, Verna, Goa, Goa 403722, India (IND) | Analytical testing, Labelling, Finished drug manufacture, Packaging | 3006644152918608431 |
| AnaCipher CLINICAL RESEARCH ORGANIZATIONRegistrant: Indoco Remedies Limited | 2nd, 3rd and 4th Floor, Mirrakamshetty Mall, Ramanthapur, Medchal-Malkajgiri District, Hyderabad, Telangana 500 013, India (IND) | Analytical testing | 3007112162650654655 |
| INDOCO REMEDIES LIMITEDRegistrant: Indoco Remedies Limited | Kilolab, R-92/93, 1st Floor, T.T.C., M.I.D.C. Thane Belapur Road, Rabale, Navi Mumbai, Maharashtra 400701, India (IND) | Analytical testing, Active ingredient (API) manufacture, Labelling, Packaging | 3006620783675888404 |
| INDOCO REMEDIES LIMITEDRegistrant: Indoco Remedies Limited | A-26, A-27, A-28/1, A-28/2, M.I.D.C. Industrial Area, Patalganga, Village Kaire, Taluka Khalapur, Dist. Raigad, Raigad, Maharashtra 410220, India (IND) | Analytical testing, Active ingredient (API) manufacture, Labelling, Packaging | 3006784730650455566 |
Catalogue
Drug listings by form and route
5858 active NDC listings: 33 human prescription drug, 24 bulk ingredient, 1 human otc drug. By marketing category: ANDA 34, BULK INGREDIENT 24.
| Dosage form | NDCs |
|---|---|
| powder | 23 |
| tablet, film coated | 9 |
| capsule | 8 |
| tablet | 7 |
| injection | 5 |
| solution/ drops | 3 |
| kit | 1 |
| powder, for solution | 1 |
| tablet, coated | 1 |
| Route | NDCs |
|---|---|
| oral | 25 |
| intravenous | 5 |
| ophthalmic | 3 |
| intramuscular | 1 |
| Labeller name on the listing | NDCs |
|---|---|
| indoco remedies limited | 58 |
Catalogue
Marketed products
58| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| ACETYLCYSTEINE | ACETYLCYSTEINE | injection, intravenous | 14445-412ANDA |
| - | Allopurinol | powder | 14445-001BULK INGREDIENT |
| Allopurinol | Allopurinol | tablet, oral | 14445-170ANDA |
| Allopurinol | Allopurinol | tablet, oral | 14445-171ANDA |
| Allopurinol | Allopurinol | tablet, oral | 14445-172ANDA |
| - | Alogliptin Benzoate | powder | 14445-016BULK INGREDIENT |
| - | Apixaban | powder | 14445-014BULK INGREDIENT |
| - | Aripiprazole | powder | 14445-019BULK INGREDIENT |
| - | Besifloxacin Hydrochloride | powder | 14445-013BULK INGREDIENT |
| - | Betaxolol Hydrochloride | powder | 14445-002BULK INGREDIENT |
| Brimonidine Tartrate | Brimonidine Tartrate | solution/ drops, ophthalmic | 14445-400ANDA |
| - | Brinzolamide | powder | 14445-010BULK INGREDIENT |
| CETIRIZINE HYDROCHLORIDE | CETIRIZINE HYDROCHLORIDE | tablet, film coated, oral | 14445-152ANDA |
| - | Canagliflozin | powder | 14445-017BULK INGREDIENT |
| DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALETAE | ddorzolamide hydrochloride timolol maleate | solution/ drops, ophthalmic | 14445-405ANDA |
| Dorzolamide Hydrochloride | Dorzolamide | solution/ drops, ophthalmic | 14445-404ANDA |
| - | Febuxostat | powder | 14445-011BULK INGREDIENT |
| - | Gliclazide | powder | 14445-025BULK INGREDIENT |
| - | Glimepiride | powder | 14445-018BULK INGREDIENT |
| - | Lacosamide | powder | 14445-012BULK INGREDIENT |
| - | Lacosamide | powder, for solution | 14445-021BULK INGREDIENT |
| - | Lacosamide | powder | 14445-023BULK INGREDIENT |
| Lacosamide | Lacosamide | tablet, oral | 14445-129ANDA |
| Lacosamide | Lacosamide | tablet, oral | 14445-130ANDA |
| Lacosamide | Lacosamide | tablet, oral | 14445-131ANDA |
| Lacosamide | Lacosamide | tablet, oral | 14445-132ANDA |
| Lacosamide | Lacosamide | injection, intravenous | 14445-406ANDA |
| Lofexidine | Lofexidine | tablet, coated, oral | 14445-146ANDA |
| - | Metoprolol Succinate | powder | 14445-022BULK INGREDIENT |
| NEOSTIGMINE METHYLSULFATE | NEOSTIGMINE METHYLSULFATE | injection, intravenous | 14445-413ANDA |
| NEOSTIGMINE METHYLSULFATE | NEOSTIGMINE METHYLSULFATE | injection, intravenous | 14445-414ANDA |
| - | Neostigmine Methylsulfate | powder | 14445-015BULK INGREDIENT |
| - | Olopatadine Hydrochloride | powder | 14445-009BULK INGREDIENT |
| - | Rivaroxaban | powder | 14445-024BULK INGREDIENT |
| - | Rivaroxaban | powder | 14445-026BULK INGREDIENT |
| Rivaroxaban | Rivaroxaban | tablet, film coated, oral | 14445-147ANDA |
| Rivaroxaban | Rivaroxaban | tablet, film coated, oral | 14445-148ANDA |
| Rivaroxaban | Rivaroxaban | tablet, film coated, oral | 14445-183ANDA |
| Rivaroxaban | Rivaroxaban | tablet, film coated, oral | 14445-184ANDA |
| Succinylcholine Chloride | Succinylcholine Chloride | injection, intramuscular, intravenous | 14445-407ANDA |
| Varenicline | Varenicline Tartrate | kit | 14445-155ANDA |
| Varenicline tartrate | Varenicline tartrate | tablet, film coated, oral | 14445-153ANDA |
| Varenicline tartrate | Varenicline tartrate | tablet, film coated, oral | 14445-154ANDA |
| apixaban | apixaban | tablet, film coated, oral | 14445-149ANDA |
| apixaban | apixaban | tablet, film coated, oral | 14445-150ANDA |
| - | brimonidine tartrate | powder | 14445-003BULK INGREDIENT |
| - | bromfenac sodium | powder | 14445-008BULK INGREDIENT |
| - | dicycloamine hydrochloride | powder | 14445-004BULK INGREDIENT |
| - | dorzolamide hydrochloride | powder | 14445-006BULK INGREDIENT |
| pregabalin | pregabalin | capsule, oral | 14445-123ANDA |
| pregabalin | pregabalin | capsule, oral | 14445-124ANDA |
| pregabalin | pregabalin | capsule, oral | 14445-125ANDA |
| pregabalin | pregabalin | capsule, oral | 14445-126ANDA |
| pregabalin | pregabalin | capsule, oral | 14445-127ANDA |
| pregabalin | pregabalin | capsule, oral | 14445-128ANDA |
| pregabalin | pregabalin | capsule, oral | 14445-173ANDA |
| pregabalin | pregabalin | capsule, oral | 14445-174ANDA |
| - | rasgiline mesylate | powder | 14445-007BULK INGREDIENT |
Neighbours
Registered in the same town
12- HARMAN FINOCHEM LIMITEDChhatrapati Sambhajinagar, IND · 4 sites
- Viatris Inc.Chhatrapati Sambhajinagar, IND; Hyderabad, IND · 3 sites
- Viyash Scientific LimitedHyderabad, IND; Raigad, IND · 2 sites
- Matrix Pharmacorp Private LimitedHyderabad, IND · 2 sites
- Sandoz Industrial Products S.ANavi Mumbai, IND · 2 sites
- GLAND PHARMA LIMITEDHyderabad, IND · 2 sites
- Sai Life Sciences LimitedHyderabad, IND · 2 sites
- AKRON FORMULATIONS INDIA PRIVATE LIMITEDHyderabad, IND · 2 sites
- DifGen Pharmaceuticals LLCHyderabad, IND · 2 sites
- Jeevan Scientific Technology LimitedHyderabad, IND · 2 sites
- STARTECH LABS PRIVATE LIMITEDHyderabad, IND · 2 sites
- VENKAR CHEMICALS PRIVATE LIMITEDHyderabad, IND · 2 sites
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Enquiry
Common questions
- Is Indoco Remedies Limited FDA approved?
- Indoco Remedies Limited holds 7 FDA-registered establishments in India. 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 Indoco Remedies Limited's drugs manufactured?
- The FDA register lists Chhatrapati Sambhajinagar; District: Aurangabad (Chhatrapati Sambhajinagar); Goa; Hyderabad; Navi Mumbai; Raigad. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging.
- What drugs does Indoco Remedies Limited make?
- 58 products are listed under Indoco Remedies Limited in the openFDA NDC Directory, most often as powder; tablet, film coated; capsule. 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.