Register entry

HOVIONE FARMACIENCIA, S.A.

Data as of · How to read this entry

Registered sites
4
Active NDC listings
47
Labeller names
3
Live patents
0
Countries
4
Base
United States
Authorisation

Registered operations

Analytical testing4Active ingredient (API) manufacture4Finished drug manufacture3
Sites

Registered establishments

4
EstablishmentAddressRegistered forFEI / DUNS
HOVIONE LIMITEDRegistrant: HOVIONE FARMACIENCIA, S.A.Loughbeg, RINGASKIDDY, CORK P43 DY23, Ireland (IRL)Analytical testing, Active ingredient (API) manufacture, Finished drug manufacture3008058822985003840
HOVIONE PHARMASCIENCE LIMITEDRegistrant: HOVIONE FARMACIENCIA, S.A.154 Estrada Coronel Nicolau de Mesquita, Taipa, -, Macau (MAC)Analytical testing, Active ingredient (API) manufacture3002807210854974342
HOVIONE FARMACIENCIA, S.A.Quinta Sao Pedro, Loures, 2674-506, Portugal (PRT)Analytical testing, Active ingredient (API) manufacture, Finished drug manufacture3002807208449818434
HOVIONE LLCRegistrant: HOVIONE FARMACIENCIA, S.A.40 Lake Dr, East Windsor, New Jersey (NJ) 08520-5321, United States (USA)Analytical testing, Active ingredient (API) manufacture, Finished drug manufacture3006106736038153735
Catalogue

Drug listings by form and route

47

47 active NDC listings: 30 drug for further processing, 17 bulk ingredient. By marketing category: DRUG FOR FURTHER PROCESSING 30, BULK INGREDIENT 17.

Dosage formNDCs
powder45
capsule1
tablet, coated1
RouteNDCs
Labeller name on the listingNDCs
hovione farmaciencia sa21
hovione farmaciencia sa21
hovione farmaciencia s.a.5
Catalogue

Marketed products

47
BrandGeneric nameForm / routeNDC
-26% HM30181 based solid dispersionpowder50909-1904DRUG FOR FURTHER PROCESSING
-ALXN2040/HPMCAS Solid Dispersionpowder50909-1907DRUG FOR FURTHER PROCESSING
-Apalutamide solid dispersion intermediatepowder50909-1912DRUG FOR FURTHER PROCESSING
-Belzutifan Spray Dried Intermediatepowder50909-1917DRUG FOR FURTHER PROCESSING
-Betamethasone Acetatepowder50909-5103BULK INGREDIENT
-Betamethasone sodium phosphatepowder50909-5102BULK INGREDIENT
-DHE Spray Dried Dispersionpowder50909-1926DRUG FOR FURTHER PROCESSING
-Deutivacaftor spray dried dispersionpowder50909-1908DRUG FOR FURTHER PROCESSING
-Doravirine Spray Driedpowder50909-1918DRUG FOR FURTHER PROCESSING
-Doxycyclinepowder50909-8106BULK INGREDIENT
-Doxycycline Hyclatepowder50909-8105BULK INGREDIENT
-ENSIFENTRINEpowder50909-1705BULK INGREDIENT
-Elbasvir SDpowder50909-1919DRUG FOR FURTHER PROCESSING
-Fluticasone Propionatepowder50909-5175BULK INGREDIENT
-Fluticasone furoatepowder50909-5171BULK INGREDIENT
-Grazoprevir SDpowder50909-1916DRUG FOR FURTHER PROCESSING
-HYDROCORTISONE ACEPONATEpowder50909-5263BULK INGREDIENT
-Halobetasol Propionatepowder50909-5157BULK INGREDIENT
-ISAVUCONAZONIUM SULFATEpowder50909-1703BULK INGREDIENT
-Ivacaftor spray dried dispersionpowder50909-1902DRUG FOR FURTHER PROCESSING
-Ivosidenib solid dispersion intermediatepowder50909-1909DRUG FOR FURTHER PROCESSING
-Ledipasvir SDD 50% w/wpowder50909-1920DRUG FOR FURTHER PROCESSING
-MOMETASONE FUROATE MONOHYDRATEpowder50909-5152BULK INGREDIENT
-Minocycline Hydrochloridepowder50909-9101BULK INGREDIENT
-Minocycline Hydrochloridepowder50909-9201BULK INGREDIENT
-Mometasone Furoatepowder50909-5151BULK INGREDIENT
-Orforglipron SDDpowder50909-1924DRUG FOR FURTHER PROCESSING
-Orforglipron SDDpowder50909-1925DRUG FOR FURTHER PROCESSING
-Paltusotine.HCl SDDpowder50909-1913DRUG FOR FURTHER PROCESSING
-Pirtobrutinib SDDpowder50909-1923DRUG FOR FURTHER PROCESSING
-Pralsetinib SDD intermediatepowder50909-1905DRUG FOR FURTHER PROCESSING
-QUIZARTINIB DIHYDROCHLORIDE SDDpowder50909-1915DRUG FOR FURTHER PROCESSING
-Salmeterol Xinafoatepowder50909-4102BULK INGREDIENT
-Sarolaner SDDpowder50909-1901DRUG FOR FURTHER PROCESSING
-Solid Dispersion of BMS-986165-01powder50909-1906DRUG FOR FURTHER PROCESSING
-Sonrotoclax (BGB-11417) SDDpowder50909-1928DRUG FOR FURTHER PROCESSING
-Suzetrigine spay dried dispersionpowder50909-1910DRUG FOR FURTHER PROCESSING
-Tenapanor hydrochloridepowder50909-1706BULK INGREDIENT
-Tezacaftor spray dried dispersionpowder50909-1903DRUG FOR FURTHER PROCESSING
-Tobramycin 28mg Inhalation Powder Hard Capsulecapsule50909-2001DRUG FOR FURTHER PROCESSING
-Tucatinib solid dispersion intermediatepowder50909-1911DRUG FOR FURTHER PROCESSING
-Velpatasvir SDD 50% w/wpowder50909-1921DRUG FOR FURTHER PROCESSING
-Vepdegestrant Spray Dried Dispersionpowder50909-1927DRUG FOR FURTHER PROCESSING
-Viseltinibpowder50909-1707BULK INGREDIENT
-Voxilaprevir SDDpowder50909-1922DRUG FOR FURTHER PROCESSING
-Zongertinib Film-Coated Tablets, 60 mgtablet, coated50909-2002DRUG FOR FURTHER PROCESSING
-Zongertinib SDD intermediatepowder50909-1914DRUG FOR FURTHER PROCESSING
Neighbours

Registered in the same town

6
Compare

Comparable companies in United States

Enquiry

Common questions

Is HOVIONE FARMACIENCIA, S.A. FDA approved?
HOVIONE FARMACIENCIA, S.A. holds 4 FDA-registered establishments across 4 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 HOVIONE FARMACIENCIA, S.A.'s drugs manufactured?
At registered sites in Ireland, Macau, Portugal, the United States. The FDA register lists RINGASKIDDY; Taipa; Loures; East Windsor, NJ. Registered operations: analytical testing, active ingredient (API) manufacture, finished drug manufacture.
What drugs does HOVIONE FARMACIENCIA, S.A. make?
47 products are listed under HOVIONE FARMACIENCIA, S.A. in the openFDA NDC Directory, most often as powder; capsule; tablet, coated. 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.