Register entry
UMEDICA LABORATORIES PRIVATE LIMITED
Data as of · How to read this entry
- Registered sites
- 1
- Active NDC listings
- 52
- Live patents
- 0
- Countries
- 1
- Base
- India
Authorisation
Registered operations
Analytical testing1Finished drug manufacture1Packaging1
Sites
Registered establishments
1| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| UMEDICA LABORATORIES PRIVATE LIMITED | Plot No. 221 and 221/1, GIDC, IInd Phase,, Vapi, Gujarat 396195, India (IND) | Analytical testing, Finished drug manufacture, Packaging | 3008460260920635096 |
Catalogue
Drug listings by form and route
5252 active NDC listings: 52 human prescription drug. By marketing category: ANDA 52.
| Dosage form | NDCs |
|---|---|
| tablet | 20 |
| tablet, film coated | 15 |
| capsule | 7 |
| tablet, extended release | 5 |
| tablet, delayed release | 3 |
| kit | 1 |
| powder, for solution | 1 |
| Route | NDCs |
|---|---|
| oral | 51 |
| Labeller name on the listing | NDCs |
|---|---|
| umedica laboratories usa inc. | 52 |
Catalogue
Marketed products
52| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| Atorvastatin calcium | Atorvastatin calcium | tablet, oral | 60290-039ANDA |
| Atorvastatin calcium | Atorvastatin calcium | tablet, oral | 60290-040ANDA |
| Atorvastatin calcium | Atorvastatin calcium | tablet, oral | 60290-041ANDA |
| Atorvastatin calcium | Atorvastatin calcium | tablet, oral | 60290-042ANDA |
| CELECOXIB | CELECOXIB | capsule, oral | 60290-016ANDA |
| CELECOXIB | CELECOXIB | capsule, oral | 60290-017ANDA |
| CELECOXIB | CELECOXIB | capsule, oral | 60290-018ANDA |
| CELECOXIB | CELECOXIB | capsule, oral | 60290-019ANDA |
| Carbamazepine | Carbamazepine | tablet, oral | 60290-008ANDA |
| Carbamazepine | Carbamazepine | tablet, oral | 60290-034ANDA |
| Carbamazepine | Carbamazepine | tablet, extended release, oral | 60290-058ANDA |
| Carbamazepine | Carbamazepine | tablet, extended release, oral | 60290-059ANDA |
| Carbamazepine | Carbamazepine | tablet, extended release, oral | 60290-060ANDA |
| Chlorthalidone | Chlorthalidone | tablet, oral | 60290-004ANDA |
| Chlorthalidone | Chlorthalidone | tablet, oral | 60290-005ANDA |
| DICLOFENAC POTASSIUM | Diclofenac potassium | powder, for solution, oral | 60290-061ANDA |
| Diclofenac Potassium | Diclofenac Potassium Tablets | tablet, film coated, oral | 60290-057ANDA |
| Diclofenac Potassium | Diclofenac Potassium Tablets | tablet, film coated, oral | 60290-088ANDA |
| Diclofenac Sodium | Diclofenac Sodium | tablet, delayed release, oral | 60290-082ANDA |
| Diclofenac Sodium | Diclofenac Sodium | tablet, delayed release, oral | 60290-083ANDA |
| Diclofenac Sodium | Diclofenac Sodium | tablet, delayed release, oral | 60290-084ANDA |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | tablet, oral | 60290-009ANDA |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | tablet, oral | 60290-010ANDA |
| OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | tablet, oral | 60290-011ANDA |
| Olmesartan Medoxomil and Hydrochlorothiazide | Olmesartan Medoxomil and Hydrochlorothiazide | tablet, oral | 60290-025ANDA |
| Olmesartan Medoxomil and Hydrochlorothiazide | Olmesartan Medoxomil and Hydrochlorothiazide | tablet, oral | 60290-026ANDA |
| Olmesartan Medoxomil and Hydrochlorothiazide | Olmesartan Medoxomil and Hydrochlorothiazide | tablet, oral | 60290-102ANDA |
| Oxcarbazepine | Oxcarbazepine | tablet, film coated, oral | 60290-067ANDA |
| Oxcarbazepine | Oxcarbazepine | tablet, film coated, oral | 60290-068ANDA |
| Oxcarbazepine | Oxcarbazepine | tablet, film coated, oral | 60290-069ANDA |
| Ranolazine | Ranolazine | tablet, extended release, oral | 60290-055ANDA |
| Ranolazine | Ranolazine | tablet, extended release, oral | 60290-056ANDA |
| Rosuvastatin Calcium | Rosuvastatin Calcium | tablet, oral | 60290-043ANDA |
| Rosuvastatin Calcium | Rosuvastatin Calcium | tablet, oral | 60290-044ANDA |
| Rosuvastatin Calcium | Rosuvastatin Calcium | tablet, oral | 60290-045ANDA |
| Rosuvastatin Calcium | Rosuvastatin Calcium | tablet, oral | 60290-046ANDA |
| SILDENAFIL CITRATE | SILDENAFIL CITRATE | tablet, film coated, oral | 60290-002ANDA |
| SILDENAFIL CITRATE | SILDENAFIL CITRATE | tablet, film coated, oral | 60290-003ANDA |
| SILDENAFIL CITRATE | SILDENAFIL CITRATE | tablet, film coated, oral | 60290-079ANDA |
| Sacubitril and Valsartan | Sacubitril and Valsartan | tablet, film coated, oral | 60290-085ANDA |
| Sacubitril and Valsartan | Sacubitril and Valsartan | tablet, film coated, oral | 60290-086ANDA |
| Sacubitril and Valsartan | Sacubitril and Valsartan | tablet, film coated, oral | 60290-087ANDA |
| Sertraline HCl | Sertraline hydrochloride | capsule, oral | 60290-070ANDA |
| Sertraline HCl | Sertraline hydrochloride | capsule, oral | 60290-071ANDA |
| Tadalafil | Tadalafil | tablet, film coated, oral | 60290-027ANDA |
| Tadalafil | Tadalafil | tablet, film coated, oral | 60290-028ANDA |
| Tadalafil | Tadalafil | tablet, film coated, oral | 60290-029ANDA |
| Tadalafil | Tadalafil | tablet, film coated, oral | 60290-030ANDA |
| VARENICLINE | VARENICLINE | tablet, oral | 60290-077ANDA |
| VARENICLINE | VARENICLINE | tablet, oral | 60290-078ANDA |
| Zolpidem Tartrate | Zolpidem Tartrate | capsule, oral | 60290-089ANDA |
| varenicline | varenicline | kit | 60290-095ANDA |
Neighbours
Registered in the same town
3- Megafine Pharma (P) LimitedVapi, IND
- Unimark Remedies LimitedVapi, IND
- Swati Spentose Pvt. Ltd.Vapi, IND
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Enquiry
Common questions
- Is UMEDICA LABORATORIES PRIVATE LIMITED FDA approved?
- UMEDICA LABORATORIES PRIVATE LIMITED holds 1 FDA-registered establishment 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 UMEDICA LABORATORIES PRIVATE LIMITED's drugs manufactured?
- The FDA register lists Vapi. Registered operations: analytical testing, finished drug manufacture, packaging.
- What drugs does UMEDICA LABORATORIES PRIVATE LIMITED make?
- 52 products are listed under UMEDICA LABORATORIES PRIVATE LIMITED in the openFDA NDC Directory, most often as tablet; 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.