Register entry
- Registered sites
- 1
- Active NDC listings
- 0
- Live patents
- 35
- Countries
- 1
- Base
- United States
Authorisation
Registered operations
Analytical testing1Labelling1Finished drug manufacture1Packaging1
Sites
Registered establishments
1| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Osmotica Pharmaceutical US LLC | 895 Sawyer Rd, Marietta, Georgia (GA) 30062, United States (USA) | Analytical testing, Labelling, Finished drug manufacture, Packaging | 3009078927080299818 |
Exclusivity
Patents and exclusivities
35| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 10265308 | RELEXXIImethylphenidate hydrochloride | product | Feb 2037 |
| 10695336 | RELEXXIImethylphenidate hydrochloride | use | Feb 2037 |
| 9707217 | RELEXXIImethylphenidate hydrochloride | product | Feb 2037 |
| 9827234 | RELEXXIImethylphenidate hydrochloride | use | Feb 2037 |
| 9855258 | RELEXXIImethylphenidate hydrochloride | product | Feb 2037 |
Neighbours
Registered in the same town
2- North American Science Associates, LLCMarietta, GA
- Cosco International, Inc.Marietta, GA
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Enquiry
Common questions
- Is Osmotica Pharmaceutical US LLC FDA approved?
- Osmotica Pharmaceutical US 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 Osmotica Pharmaceutical US LLC's drugs manufactured?
- The FDA register lists Marietta, GA. Registered operations: analytical testing, labelling, finished drug manufacture, packaging.
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.