Register entry
- Registered sites
- 3
- Active NDC listings
- 15
- Live patents
- 2
- Exclusivities
- 1
- Countries
- 1
- Base
- United States
Authorisation
Registered operations
Analytical testing2Finished drug manufacture1
Sites
Registered establishments
3| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Ultragenyx Pharmaceutical Inc. | 170 Middlesex Tpke, Bedford, Massachusetts (MA) 01730, United States (USA) | Finished drug manufacture | 3025268614119414797 |
| Ultragenyx Pharmaceutical Inc. | 60 Leveroni Court, Novato, California (CA) 94949, United States (USA) | Analytical testing | 3012208691962892019 |
| Ultragenyx Pharmaceutical Inc. | 150 Presidential Way, Woburn, Massachusetts (MA) 01801, United States (USA) | Analytical testing | 3023224237118377074 |
Catalogue
Drug listings by form and route
1515 active NDC listings: 15 human prescription drug. By marketing category: BLA 14, NDA 1.
| Dosage form | NDCs |
|---|---|
| kit | 13 |
| injection | 1 |
| liquid | 1 |
| Route | NDCs |
|---|---|
| intravenous | 1 |
| oral | 1 |
| Labeller name on the listing | NDCs |
|---|---|
| ultragenyx pharmaceutical inc. | 15 |
Exclusivity
Patents and exclusivities
2| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 8697748 | DOJOLVItriheptanoin | product | Apr 2029 |
| 12551461 | DOJOLVItriheptanoin | product | Nov 2034 |
| Product | Exclusivity | Until |
|---|---|---|
| DOJOLVITRIHEPTANOIN | ODE-311 Orphan drug | Jun 2027 |
Catalogue
Marketed products
15| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| DOJOLVI | Triheptanoin | liquid, oral | 69794-050NDA |
| GENGLYCOS | pariglasgene brecaparvovec-opnr | kit | 69794-333BLA |
| GENGLYCOS | pariglasgene brecaparvovec-opnr | kit | 69794-334BLA |
| GENGLYCOS | pariglasgene brecaparvovec-opnr | kit | 69794-335BLA |
| GENGLYCOS | pariglasgene brecaparvovec-opnr | kit | 69794-336BLA |
| GENGLYCOS | pariglasgene brecaparvovec-opnr | kit | 69794-337BLA |
| GENGLYCOS | pariglasgene brecaparvovec-opnr | kit | 69794-338BLA |
| GENGLYCOS | pariglasgene brecaparvovec-opnr | kit | 69794-339BLA |
| GENGLYCOS | pariglasgene brecaparvovec-opnr | kit | 69794-340BLA |
| GENGLYCOS | pariglasgene brecaparvovec-opnr | kit | 69794-341BLA |
| GENGLYCOS | pariglasgene brecaparvovec-opnr | kit | 69794-342BLA |
| GENGLYCOS | pariglasgene brecaparvovec-opnr | kit | 69794-343BLA |
| GENGLYCOS | pariglasgene brecaparvovec-opnr | kit | 69794-344BLA |
| GENGLYCOS | pariglasgene brecaparvovec-opnr | kit | 69794-345BLA |
| MEPSEVII | vestronidase alfa | injection, intravenous | 69794-001BLA |
Neighbours
Registered in the same town
6- PETNET Solutions, Inc.WOBURN, MA
- Oxford Biomedica (UK) LimitedBedford, MA
- Safecor Health, LLCWoburn, MA
- BioMarin International LimitedNovato, CA
- AGP LLCWoburn, MA
- Ocular Therapeutix, Inc.Bedford, MA
Compare
Comparable companies in United States
- International Medication Systems, Ltd.3 sites · 2,801 NDC
- Alk-Abello, Inc.3 sites · 412 NDC
- Conopco, Inc. d/b/a Unilever3 sites · 374 NDC
- L. Perrigo Company3 sites · 243 NDC
- Epic Laboratories, LLC3 sites · 209 NDC
- Safecor Health, LLC3 sites · 103 NDC
- ProPharma Distribution, LLC.3 sites · 100 NDC
- B. Braun US Pharmaceutical Manufacturing LLC3 sites · 94 NDC
- Aurolife Pharma LLC3 sites · 70 NDC
- Elementis Specialties (India) Private Limited3 sites · 69 NDC
Enquiry
Common questions
- Is Ultragenyx Pharmaceutical Inc. FDA approved?
- Ultragenyx Pharmaceutical Inc. holds 3 FDA-registered establishments 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 Ultragenyx Pharmaceutical Inc.'s drugs manufactured?
- The FDA register lists Bedford, MA; Novato, CA; Woburn, MA. Registered operations: analytical testing, finished drug manufacture.
- What drugs does Ultragenyx Pharmaceutical Inc. make?
- 15 products are listed under Ultragenyx Pharmaceutical Inc. in the openFDA NDC Directory, most often as kit; injection; liquid. 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.