Register entry
- Registered sites
- 2
- Active NDC listings
- 19
- Labeller names
- 2
- Live patents
- 28
- Exclusivities
- 1
- Countries
- 2
- Base
- United States
Authorisation
Registered operations
Analytical testing2Active ingredient (API) manufacture2Labelling2Finished drug manufacture2Packaging1
Sites
Registered establishments
2| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| BioMarin International Limited | Shanbally, RINGASKIDDY, , Ireland (IRL) | Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging | 3010085632985066780 |
| BioMarin Pharmaceutical Inc. | 46 Galli Drive, Novato, California (CA) 94949, United States (USA) | Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture | 3004079983010004135 |
Catalogue
Drug listings by form and route
1919 active NDC listings: 12 human prescription drug, 7 drug for further processing. By marketing category: DRUG FOR FURTHER PROCESSING 7, BLA 6, NDA 6.
| Dosage form | NDCs |
|---|---|
| injection, solution | 7 |
| injection, solution, concentrate | 4 |
| kit | 4 |
| powder, for solution | 2 |
| solution | 1 |
| tablet | 1 |
| Route | NDCs |
|---|---|
| oral | 3 |
| subcutaneous | 3 |
| intravenous | 2 |
| Labeller name on the listing | NDCs |
|---|---|
| biomarin pharmaceutical inc. | 17 |
| biomarin international limited | 2 |
Exclusivity
Patents and exclusivities
28| Patent | Product | Covers | Expiry |
|---|---|---|---|
| RE48267 | VOXZOGOvosoritide | use | May 2030 |
| 9216178 | KUVANsapropterin dihydrochloride | product | Nov 2032 |
| 9216178*PED | KUVANsapropterin dihydrochloride | use | May 2033 |
| 8198242 | VOXZOGOvosoritide | substance, product | Jun 2035 |
| 10646550 | VOXZOGOvosoritide | product | Aug 2036 |
| 11590204 | VOXZOGOvosoritide | product | Aug 2036 |
| 11911446 | VOXZOGOvosoritide | use | Aug 2036 |
| 12514906 | VOXZOGOvosoritide | product | Aug 2036 |
| 9907834 | VOXZOGOvosoritide | product | Aug 2036 |
| 12233106 | VOXZOGOvosoritide | use | Jul 2042 |
| Product | Exclusivity | Until |
|---|---|---|
| VOXZOGOVOSORITIDE | ODE-449 Orphan drug | Oct 2030 |
Catalogue
Marketed products
19| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| Brineura | cerliponase alfa | kit | 68135-811BLA |
| Kuvan | SAPROPTERIN DIHYDROCHLORIDE | tablet, oral | 68135-300NDA |
| Kuvan | SAPROPTERIN DIHYDROCHLORIDE | powder, for solution, oral | 68135-301NDA |
| Kuvan | sapropterin dihydrochloride | powder, for solution, oral | 68135-482NDA |
| NAGLAZYME | galsulfase | solution, intravenous | 68135-020BLA |
| Palynziq | pegvaliase-pqpz | injection, solution, subcutaneous | 68135-058BLA |
| Palynziq | pegvaliase-pqpz | injection, solution, subcutaneous | 68135-673BLA |
| Palynziq | pegvaliase-pqpz | injection, solution, subcutaneous | 68135-756BLA |
| VIMIZIM | elosulfase alfa | injection, solution, concentrate, intravenous | 68135-100BLA |
| - | VOSORITIDE | injection, solution, concentrate | 68135-062DRUG FOR FURTHER PROCESSING |
| VOXZOGO 0.4mg | vosoritide | kit | 68135-082NDA |
| VOXZOGO 0.56mg | vosoritide | kit | 68135-119NDA |
| VOXZOGO 1.2mg | vosoritide | kit | 68135-181NDA |
| - | cerliponase alfa | injection, solution | 68135-502DRUG FOR FURTHER PROCESSING |
| - | cerliponase alfa | injection, solution | 71931-820DRUG FOR FURTHER PROCESSING |
| - | elosulfase alfa | injection, solution, concentrate | 71931-500DRUG FOR FURTHER PROCESSING |
| - | laronidase | injection, solution, concentrate | 68135-000DRUG FOR FURTHER PROCESSING |
| - | pegvaliase-pqpz | injection, solution | 68135-060DRUG FOR FURTHER PROCESSING |
| - | pegvaliase-pqpz | injection, solution | 68135-117DRUG FOR FURTHER PROCESSING |
Neighbours
Registered in the same town
1- Ultragenyx Pharmaceutical Inc.Novato, CA
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Enquiry
Common questions
- Is BioMarin International Limited FDA approved?
- BioMarin International Limited holds 2 FDA-registered establishments across 2 countries. 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 BioMarin International Limited's drugs manufactured?
- At registered sites in Ireland, the United States. The FDA register lists Shanbally; Novato, CA. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging.
- What drugs does BioMarin International Limited make?
- 19 products are listed under BioMarin International Limited in the openFDA NDC Directory, most often as injection, solution; injection, solution, concentrate; kit. 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.