Register entry
Unichem Laboratories Limited, India
Data as of · How to read this entry
- Registered sites
- 5
- Active NDC listings
- 272
- Labeller names
- 3
- Live patents
- 0
- Countries
- 1
- Base
- India
Authorisation
Registered operations
Analytical testing5Active ingredient (API) manufacture3Labelling2Finished drug manufacture2Packaging2
Sites
Registered establishments
5| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Unichem Laboratories LimitedRegistrant: Unichem Laboratories Limited, India | Plot No. 10 to 18, Pilerne Industrial Estate, Pilerne, Bardez, Goa 403511, India (IND) | Analytical testing, Labelling, Finished drug manufacture, Packaging | 3005497507915389741 |
| Unichem Laboratories LimitedRegistrant: Unichem Laboratories Limited, India | Plot No. 197, Sector-1, Pithampur, Dhar, Madhya Pradesh 454775, India (IND) | Analytical testing, Active ingredient (API) manufacture | 3006456888650434371 |
| Unichem Laboratories LimitedRegistrant: Unichem Laboratories Limited, India | C-31, 32 & D-10, Industrial Area, Meerut Road, Ghaziabad, Uttar Pradesh 201003, India (IND) | Analytical testing, Labelling, Finished drug manufacture, Packaging | 3004082076862383163 |
| Unichem Laboratories LimitedRegistrant: Unichem Laboratories Limited, India | Plot No. T-47, Five Star MIDC, Kagal - Hatkanangale, Kolhapur, Maharashtra 416236, India (IND) | Analytical testing, Active ingredient (API) manufacture | 3013585679871412278 |
| Unichem Laboratories LimitedRegistrant: Unichem Laboratories Limited, India | Plot No. 99, MIDC Area, Roha, Raigad, Maharashtra 402116, India (IND) | Analytical testing, Active ingredient (API) manufacture | 3004373180918598095 |
Catalogue
Drug listings by form and route
272272 active NDC listings: 209 human prescription drug, 61 bulk ingredient, 2 human otc drug. By marketing category: ANDA 211, BULK INGREDIENT 61.
| Dosage form | NDCs |
|---|---|
| tablet | 100 |
| powder | 61 |
| tablet, film coated | 59 |
| capsule | 20 |
| tablet, extended release | 14 |
| tablet, film coated, extended release | 5 |
| tablet, orally disintegrating | 4 |
| capsule, extended release | 3 |
| tablet, delayed release | 3 |
| tablet, chewable | 2 |
| solution | 1 |
| Route | NDCs |
|---|---|
| oral | 210 |
| ophthalmic | 1 |
| Labeller name on the listing | NDCs |
|---|---|
| unichem pharmaceuticals (usa), inc. | 189 |
| unichem laboratories limited, india | 62 |
| unichem pharmaceuticals (usa), inc. | 21 |
Catalogue
Marketed products
272Showing 150 of 272.
| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| - | Alfuzosin Hydrochloride | powder | 53747-019BULK INGREDIENT |
| Alfuzosin hydrochloride | Alfuzosin hydrochloride | tablet, extended release, oral | 29300-155ANDA |
| Allopurinol | Allopurinol | tablet, oral | 29300-349ANDA |
| Allopurinol | Allopurinol | tablet, oral | 29300-350ANDA |
| Amiodarone Hydrochloride | Amiodarone Hydrochloride | tablet, oral | 29300-359ANDA |
| Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | tablet, film coated, oral | 29300-419ANDA |
| Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | tablet, film coated, oral | 29300-420ANDA |
| Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | tablet, film coated, oral | 29300-421ANDA |
| Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | tablet, film coated, oral | 29300-422ANDA |
| Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | tablet, film coated, oral | 29300-423ANDA |
| Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | tablet, film coated, oral | 29300-424ANDA |
| Amlodipine Besylate | Amlodipine Besylate | tablet, oral | 29300-396ANDA |
| Amlodipine Besylate | Amlodipine Besylate | tablet, oral | 29300-397ANDA |
| Amlodipine Besylate | Amlodipine Besylate | tablet, oral | 29300-398ANDA |
| - | Amlodipine Besylate | powder | 53747-011BULK INGREDIENT |
| - | Apixaban | powder | 53747-062BULK INGREDIENT |
| - | Apremilast | powder | 53747-077BULK INGREDIENT |
| Aripiprazole | Aripiprazole | tablet, oral | 29300-175ANDA |
| Aripiprazole | Aripiprazole | tablet, oral | 29300-176ANDA |
| Aripiprazole | Aripiprazole | tablet, oral | 29300-177ANDA |
| Aripiprazole | Aripiprazole | tablet, oral | 29300-178ANDA |
| Aripiprazole | Aripiprazole | tablet, oral | 29300-179ANDA |
| Aripiprazole | Aripiprazole | tablet, oral | 29300-180ANDA |
| - | Aripiprazole | powder | 53747-031BULK INGREDIENT |
| Atenolol | Atenolol | tablet, oral | 29300-410ANDA |
| Atenolol | Atenolol | tablet, oral | 29300-411ANDA |
| Atenolol | Atenolol | tablet, oral | 29300-412ANDA |
| Atenolol and Chlorthalidone | Atenolol and Chlorthalidone | tablet, oral | 29300-400ANDA |
| Atenolol and Chlorthalidone | Atenolol and Chlorthalidone | tablet, oral | 29300-401ANDA |
| - | Atomoxetine Hydrochloride | powder | 53747-059BULK INGREDIENT |
| Baclofen | Baclofen | tablet, oral | 29300-343ANDA |
| Baclofen | Baclofen | tablet, oral | 29300-344ANDA |
| Baclofen | Baclofen | tablet, oral | 29300-474ANDA |
| - | Baclofen | powder | 53747-075BULK INGREDIENT |
| - | Bendroflumethiazide | powder | 53747-004BULK INGREDIENT |
| Bisoprolol Fumarate | Bisoprolol fumarate | tablet, oral | 29300-126ANDA |
| Bisoprolol Fumarate | Bisoprolol fumarate | tablet, oral | 29300-127ANDA |
| - | Bisoprolol Fumarate | powder | 53747-009BULK INGREDIENT |
| - | Brexpiprazole | powder | 53747-084BULK INGREDIENT |
| - | Brimonidine Tartarate | powder | 53747-036BULK INGREDIENT |
| - | Buprenorphine Hydrochloride | powder | 53747-012BULK INGREDIENT |
| Buspirone Hydrochloride | Buspirone Hydrochloride | tablet, oral | 29300-244ANDA |
| Buspirone Hydrochloride | Buspirone Hydrochloride | tablet, oral | 29300-245ANDA |
| Buspirone Hydrochloride | Buspirone Hydrochloride | tablet, oral | 29300-246ANDA |
| Buspirone Hydrochloride | Buspirone Hydrochloride | tablet, oral | 29300-247ANDA |
| Buspirone Hydrochloride | Buspirone Hydrochloride | tablet, oral | 29300-477ANDA |
| Buspirone Hydrochloride | Buspirone Hydrochloride | tablet, oral | 29300-478ANDA |
| - | Buspirone hydrochloride | powder | 53747-040BULK INGREDIENT |
| Carbamazepine | Carbamazepine | tablet, oral | 29300-382ANDA |
| Carvedilol | Carvedilol | tablet, film coated, oral | 76385-110ANDA |
| Carvedilol | Carvedilol | tablet, film coated, oral | 76385-111ANDA |
| Carvedilol | Carvedilol | tablet, film coated, oral | 76385-112ANDA |
| Carvedilol | Carvedilol | tablet, film coated, oral | 76385-113ANDA |
| Celecoxib | Celecoxib | capsule, oral | 29300-157ANDA |
| Celecoxib | Celecoxib | capsule, oral | 29300-158ANDA |
| Celecoxib | Celecoxib | capsule, oral | 29300-373ANDA |
| Celecoxib | Celecoxib | capsule, oral | 29300-374ANDA |
| Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride | Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride | tablet, film coated, extended release, oral | 29300-313ANDA |
| - | Cetirizine hydrochloride | powder | 53747-013BULK INGREDIENT |
| Chlorthalidone | Chlorthalidone | tablet, oral | 29300-333ANDA |
| Chlorthalidone | Chlorthalidone | tablet, oral | 29300-334ANDA |
| - | Cinacalcet Hydrochloride | powder | 53747-056BULK INGREDIENT |
| - | Clonidine Hydrochloride | powder | 53747-010BULK INGREDIENT |
| Cyclobenzaprine hydrochloride | Cyclobenzaprine hydrochloride | tablet, film coated, oral | 29300-413ANDA |
| Cyclobenzaprine hydrochloride | Cyclobenzaprine hydrochloride | tablet, film coated, oral | 29300-414ANDA |
| Cyclobenzaprine hydrochloride | Cyclobenzaprine hydrochloride | tablet, film coated, oral | 29300-415ANDA |
| Cyproheptadine Hydrochloride | Cyproheptadine Hydrochloride | tablet, oral | 76385-130ANDA |
| Diphenoxylate Hydrochloride and Atropine Sulfate | Diphenoxylate Hydrochloride and Atropine Sulfate | tablet, oral | 76385-107ANDA |
| Divalproex Sodium | Divalproex Sodium | tablet, delayed release, oral | 29300-138ANDA |
| Divalproex Sodium | Divalproex Sodium | tablet, delayed release, oral | 29300-139ANDA |
| Divalproex Sodium | Divalproex Sodium | tablet, delayed release, oral | 29300-140ANDA |
| - | Donepezil Hydrochloride | powder | 53747-099BULK INGREDIENT |
| Doxazosin Mesylate | Doxazosin Mesylate | tablet, oral | 29300-351ANDA |
| Doxazosin Mesylate | Doxazosin Mesylate | tablet, oral | 29300-352ANDA |
| Doxazosin Mesylate | Doxazosin Mesylate | tablet, oral | 29300-353ANDA |
| Doxazosin Mesylate | Doxazosin Mesylate | tablet, oral | 29300-354ANDA |
| - | Doxazosin Mesylate | powder | 53747-076BULK INGREDIENT |
| Doxazosin Mesylate | Doxazosin Mesylate | tablet, oral | 53747-352ANDA |
| - | Eprosartan Mesylate | powder | 53747-021BULK INGREDIENT |
| Etodolac | Etodolac | tablet, film coated, oral | 76385-118ANDA |
| Etodolac | Etodolac | tablet, film coated, oral | 76385-119ANDA |
| - | Fenofibrate | powder | 53747-033BULK INGREDIENT |
| Flecainide Acetate | flecainide acetate | tablet, oral | 76385-145ANDA |
| Flecainide Acetate | flecainide acetate | tablet, oral | 76385-146ANDA |
| Flecainide Acetate | flecainide acetate | tablet, oral | 76385-147ANDA |
| - | Glipizide | powder | 53747-047BULK INGREDIENT |
| Guanfacine | Guanfacine | tablet, extended release, oral | 29300-460ANDA |
| Guanfacine | Guanfacine | tablet, extended release, oral | 29300-461ANDA |
| Guanfacine | Guanfacine | tablet, extended release, oral | 29300-462ANDA |
| Guanfacine | Guanfacine | tablet, extended release, oral | 29300-463ANDA |
| Guanfacine Hydrochloride | Guanfacine Hydrochloride | tablet, oral | 29300-458ANDA |
| Guanfacine Hydrochloride | Guanfacine Hydrochloride | tablet, oral | 29300-459ANDA |
| - | Guanfacine Hydrochloride | powder | 53747-096BULK INGREDIENT |
| - | Hydrchlorothiazide | powder | 53747-008BULK INGREDIENT |
| Hydrochlorothiazide | Hydrochlorothiazide | tablet, oral | 29300-128ANDA |
| Hydrochlorothiazide | Hydrochlorothiazide | tablet, oral | 29300-129ANDA |
| Hydrochlorothiazide | Hydrochlorothiazide | tablet, oral | 29300-485ANDA |
| - | Hydrochlorothiazide Process 2 | powder | 53747-015BULK INGREDIENT |
| Irbesartan | Irbesartan | tablet, oral | 29300-212ANDA |
| Irbesartan | Irbesartan | tablet, oral | 29300-213ANDA |
| Irbesartan | Irbesartan | tablet, oral | 29300-214ANDA |
| - | Irbesartan | powder | 53747-029BULK INGREDIENT |
| Irbesartan and Hydrochlorothiazide | Irbesartan and Hydrochlorothiazide | tablet, film coated, oral | 29300-215ANDA |
| Irbesartan and Hydrochlorothiazide | Irbesartan and Hydrochlorothiazide | tablet, film coated, oral | 29300-216ANDA |
| KETOTIFEN FUMARATE | KETOTIFEN FUMARATE | solution, ophthalmic | 76385-106ANDA |
| Labetalol Hydrochloride | Labetalol Hydrochloride | tablet, film coated, oral | 29300-252ANDA |
| Labetalol Hydrochloride | Labetalol Hydrochloride | tablet, film coated, oral | 29300-253ANDA |
| Labetalol Hydrochloride | Labetalol Hydrochloride | tablet, film coated, oral | 29300-254ANDA |
| - | Labetalol Hydrochloride | powder | 53747-037BULK INGREDIENT |
| - | Lacidipine | powder | 53747-032BULK INGREDIENT |
| Lacosamide | Lacosamide | tablet, film coated, oral | 29300-364ANDA |
| Lacosamide | Lacosamide | tablet, film coated, oral | 29300-365ANDA |
| Lacosamide | Lacosamide | tablet, film coated, oral | 29300-366ANDA |
| Lacosamide | Lacosamide | tablet, film coated, oral | 29300-367ANDA |
| - | Lacosamide | powder | 53747-069BULK INGREDIENT |
| Lamotrigine | Lamotrigine | tablet, oral | 29300-111ANDA |
| Lamotrigine | Lamotrigine | tablet, oral | 29300-112ANDA |
| Lamotrigine | Lamotrigine | tablet, oral | 29300-113ANDA |
| Lamotrigine | Lamotrigine | tablet, oral | 29300-114ANDA |
| - | Lamotrigine | powder | 53747-016BULK INGREDIENT |
| Losartan Potassium | Losartan Potassium | tablet, oral | 29300-144ANDA |
| Losartan Potassium | Losartan Potassium | tablet, oral | 29300-145ANDA |
| Losartan Potassium | Losartan Potassium | tablet, oral | 29300-146ANDA |
| - | Losartan Potassium | powder | 53747-023BULK INGREDIENT |
| - | Lurasidone hydrochloride | powder | 53747-058BULK INGREDIENT |
| METHSCOPOLAMINE BROMIDE | methscopolamine bromide | tablet, oral | 76385-100ANDA |
| METHSCOPOLAMINE BROMIDE | methscopolamine bromide | tablet, oral | 76385-101ANDA |
| - | Meloxicam | powder | 53747-006BULK INGREDIENT |
| Memantine Hydrochloride | memantine hydrochloride | tablet, film coated, oral | 29300-171ANDA |
| Memantine Hydrochloride | memantine hydrochloride | tablet, film coated, oral | 29300-172ANDA |
| - | Memantine Hydrochloride | powder | 53747-025BULK INGREDIENT |
| Metformin Hydrochloride | Metformin Hydrochloride | tablet, extended release, oral | 29300-389ANDA |
| Metformin Hydrochloride | Metformin Hydrochloride | tablet, extended release, oral | 29300-399ANDA |
| Metformin hydrochloride | Metformin hydrochloride | tablet, extended release, oral | 76385-128ANDA |
| Metformin hydrochloride ER | Metformin hydrochloride | tablet, extended release, oral | 76385-129ANDA |
| Methocarbamol | Methocarbamol | tablet, film coated, oral | 76385-123ANDA |
| Methocarbamol | Methocarbamol | tablet, film coated, oral | 76385-124ANDA |
| Metolazone | Metolazone | tablet, oral | 76385-136ANDA |
| Metolazone | Metolazone | tablet, oral | 76385-137ANDA |
| Metolazone | Metolazone | tablet, oral | 76385-138ANDA |
| Metronidazole | Metronidazole | tablet, film coated, oral | 29300-226ANDA |
| Metronidazole | Metronidazole | tablet, film coated, oral | 29300-227ANDA |
| - | Metronidazole | powder | 53747-007BULK INGREDIENT |
| - | Montelukast sodium | powder | 53747-079BULK INGREDIENT |
| Nadolol | Nadolol | tablet, oral | 76385-133ANDA |
| Nadolol | Nadolol | tablet, oral | 76385-134ANDA |
| Nadolol | Nadolol | tablet, oral | 76385-135ANDA |
| - | Nateglinide | powder | 53747-020BULK INGREDIENT |
| - | Nateglinide | powder | 53747-052BULK INGREDIENT |
| Nebivolol Hydrochloride | Nebivolol Hydrochloride | tablet, oral | 29300-375ANDA |
Neighbours
Registered in the same town
12- Felix Pharmaceuticals PVT LimitedDhar, IND · 2 sites
- Lupin LimitedDhar, IND
- Glenmark Pharmaceuticals Inc., USADhar, IND
- Viyash Scientific LimitedRaigad, IND
- CIPLA PHARMACEUTICALS LIMITEDRaigad, IND
- Indoco Remedies LimitedRaigad, IND
- Ipca Laboratories LimitedDhar, IND
- Macleods Pharmaceuticals LimitedDhar, IND
- Par Health USA, LLCDhar, IND
- Rubicon Research Canada LimitedDhar, IND
- Elementis Specialties (India) Private LimitedRaigad, IND
- Symbiotec Pharmalab LimitedDhar, IND
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Enquiry
Common questions
- Is Unichem Laboratories Limited, India FDA approved?
- Unichem Laboratories Limited, India holds 5 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 Unichem Laboratories Limited, India's drugs manufactured?
- The FDA register lists Bardez; Dhar; Ghaziabad; Kolhapur; Raigad. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging.
- What drugs does Unichem Laboratories Limited, India make?
- 272 products are listed under Unichem Laboratories Limited, India in the openFDA NDC Directory, most often as tablet; powder; tablet, film coated. 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.