Register entry
- Registered sites
- 2
- Active NDC listings
- 3
- Live patents
- 7
- Exclusivities
- 1
- Countries
- 1
- Base
- India
Authorisation
Registered operations
Analytical testing1Finished drug manufacture1
Sites
Registered establishments
2| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Wockhardt LimitedRegistrant: WOCKHARDT LIMITED | D-4, M.I.D.C. Area, Chikalthana, Aurangabad, Maharashtra 431006, India (IND) | Analytical testing | 3007523885650566198 |
| Wockhardt LimitedRegistrant: WOCKHARDT LIMITED | Plot No. E-1/1, M.I.D.C. Area, Shendra, Aurangabad, Maharashtra 431154, India (IND) | Finished drug manufacture | 3009278506864496135 |
Catalogue
Drug listings by form and route
33 active NDC listings: 3 human prescription drug. By marketing category: ANDA 3.
| Dosage form | NDCs |
|---|---|
| injection, powder, for solution | 3 |
| Route | NDCs |
|---|---|
| intravenous | 3 |
| intramuscular | 2 |
| Labeller name on the listing | NDCs |
|---|---|
| wockhardt usa llc. | 3 |
Exclusivity
Patents and exclusivities
7| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 8822450 | ZAYNICHcefepime hydrochloride; zidebactam | substance, product | Aug 2032 |
| 8853197 | ZAYNICHcefepime hydrochloride; zidebactam | substance | Aug 2032 |
| 9132133 | ZAYNICHcefepime hydrochloride; zidebactam | use | Aug 2032 |
| 9381200 | ZAYNICHcefepime hydrochloride; zidebactam | product | Aug 2032 |
| 9827235 | ZAYNICHcefepime hydrochloride; zidebactam | product | Aug 2032 |
| 9657021 | ZAYNICHcefepime hydrochloride; zidebactam | substance | Oct 2033 |
| 9834557 | ZAYNICHcefepime hydrochloride; zidebactam | substance | Oct 2033 |
| Product | Exclusivity | Until |
|---|---|---|
| ZAYNICHCEFEPIME HYDROCHLORIDE; ZIDEBACTAM | GAIN Qualified infectious disease product (GAIN) | May 2036 |
Catalogue
Marketed products
3| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| Oxacillin | Oxacillin | injection, powder, for solution, intramuscular, intravenous | 64679-698ANDA |
| Oxacillin | Oxacillin | injection, powder, for solution, intramuscular, intravenous | 64679-699ANDA |
| Oxacillin | Oxacillin | injection, powder, for solution, intravenous | 64679-700ANDA |
Neighbours
Registered in the same town
3- Curia India Private LimitedAurangabad, IND
- Gland Chemicals Private LimitedAurangabad, IND
- MIDAS CARE PHARMACEUTICALS PRIVATE LIMITEDAurangabad, IND
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- SOFTGEL HEALTHCARE PRIVATE LIMITED2 sites · 38 NDC
- Teva API India Private Ltd.2 sites · 36 NDC
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Enquiry
Common questions
- Is WOCKHARDT LIMITED FDA approved?
- WOCKHARDT LIMITED holds 2 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 WOCKHARDT LIMITED's drugs manufactured?
- The FDA register lists Aurangabad. Registered operations: analytical testing, finished drug manufacture.
- What drugs does WOCKHARDT LIMITED make?
- 3 products are listed under WOCKHARDT LIMITED in the openFDA NDC Directory, most often as injection, powder, for solution. 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.