Register entry
- Registered sites
- 1
- Active NDC listings
- 0
- Live patents
- 3
- Countries
- 1
- Base
- United States
Authorisation
Registered operations
Analytical testing1Labelling1Finished drug manufacture1Packaging1Relabelling1Repackaging1
Sites
Registered establishments
1| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Sovereign Pharmaceuticals, LLCRegistrant: SOVEREIGN PHARMACEUTICALS, LLC | 7333 Jack Newel Blvd N, Fort Worth, Texas (TX) 76118, United States (USA) | Analytical testing, Labelling, Finished drug manufacture, Packaging, Relabelling, Repackaging | 3003229412118903968 |
Exclusivity
Patents and exclusivities
3| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 10105324 | OBREDONguaifenesin; hydrocodone bitartrate | substance, product | Nov 2035 |
| 9549907 | OBREDONguaifenesin; hydrocodone bitartrate | substance, product | Nov 2035 |
| 9808431 | OBREDONguaifenesin; hydrocodone bitartrate | substance, product | Nov 2035 |
Neighbours
Registered in the same town
8- Sotera Health LLCFort Worth, TX
- Pharma Packaging Solutions, LLC dba Tjoapack, LLCFort Worth, TX
- Prime Enterprises, LLC dba Prime Matter LabsFort Worth, TX
- Alcon Laboratories, IncFort Worth, TX
- MasVida Health Care Solutions, LLCFort Worth, TX
- Cook Children's Home HealthFort Worth, TX
- Eosera IncFort Worth, TX
- Smith & Nephew, Inc.Fort Worth, TX
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Enquiry
Common questions
- Is SOVEREIGN PHARMACEUTICALS, LLC FDA approved?
- SOVEREIGN PHARMACEUTICALS, LLC holds 1 FDA-registered establishment in the United States. 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 SOVEREIGN PHARMACEUTICALS, LLC's drugs manufactured?
- The FDA register lists Fort Worth, TX. Registered operations: analytical testing, labelling, finished drug manufacture, packaging, relabelling, repackaging.
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.