Hikma Farmaceutica (Portugal), S.a
A single plant registered with the FDA to make drugs for the US market. Below is where it is and the drugs whose FDA labels list this site as performing a manufacturing step — so if this plant has a problem, these are the products that could be affected.
- Country
- Portugal
- Registered address
- ESTRADA RIO DA MO, 8/8A/8B, TERRUGEM SINTRA, 2705-906, Portugal (PRT)
- Operations here
- analysislabelmanufacturepack
- FDA identifiers
- FEI 3002807173 · DUNS 452742943
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2023-04-21
- VAIDrug Quality Assurance2023-02-03
- VAIDrug Quality Assurance2020-03-06
- NAIDrug Quality Assurance2018-03-22
- VAIDrug Quality Assurance2016-04-12
- VAIDrug Quality Assurance2015-06-19
- OAIDrug Quality Assurance2014-03-28
- VAIDrug Quality Assurance2011-09-29
- NAIDrug Quality Assurance2009-09-24
Drugs this plant is listed as making
44 distinct drugs across 112 products name this site in their FDA label.
- AcyclovirHikma Pharmaceuticals USA Inc.
- Amiodarone HydrochlorideHikma Pharmaceuticals USA Inc.
- Benztropine MesylateHikma Pharmaceuticals USA Inc.
- Butorphanol TartrateHikma Pharmaceuticals USA Inc.
- CefazolinHikma Pharmaceuticals USA Inc.
- Cefotaximein shortageHikma Pharmaceuticals USA Inc.
- CefoxitinHikma Pharmaceuticals USA Inc.
- CeftriaxoneHikma Pharmaceuticals USA Inc.
- CefuroximeHikma Pharmaceuticals USA Inc.
- Chlorpromazine hydrochlorideHikma Pharmaceuticals USA Inc.
- Clonidine HydrochlorideHikma Pharmaceuticals USA Inc.
- cyanocobalaminHikma Pharmaceuticals USA Inc.
- DigoxinHikma Pharmaceuticals USA Inc.
- DroperidolHikma Pharmaceuticals USA Inc.
- Etomidatein shortageCivica, Inc.
- FluconazoleHikma Pharmaceuticals USA Inc.
- FlumazenilHikma Pharmaceuticals USA Inc.
- Fosphenytoin SodiumWest-Ward Pharmaceuticals Corp
- Furosemidein shortageHikma Pharmaceuticals USA Inc.
- GlycopyrrolateHikma Pharmaceuticals USA Inc.
- Granisetron HydrochlorideHikma Pharmaceuticals USA Inc.
- Leucovorin CalciumBluePoint Laboratories
- LevetiracetamHikma Pharmaceuticals USA Inc.
- LevofloxacinHikma Pharmaceuticals USA Inc.
- Metoprolol TartrateHikma Pharmaceuticals USA Inc.
- Metoroprolol TartrateHikma Pharmaceuticals USA Inc.
- Milrinone LactateHikma Pharmaceuticals USA Inc.
- Milrinone Lactate in DextroseHikma Pharmaceuticals USA Inc.
- OndansetronWest-Ward Pharmaceuticals Corp
- OxytocinWest-Ward Pharmaceuticals Corp
- ProgesteroneHikma Pharmaceuticals USA Inc.
- Promethazine Hydrochloridein shortageHikma Pharmaceuticals USA Inc.
- Propranolol Hydrochloridein shortageHikma Pharmaceuticals USA Inc.
- Rifampinin shortageHikma Pharmaceuticals USA Inc.
- Rocuronium Bromidein shortageHikma Pharmaceuticals USA Inc.
- Ropivacaine Hydrochloridein shortageHikma Pharmaceuticals USA Inc.
- Sodium Ferric Gluconate Complex in SucroseHikma Pharmaceuticals USA Inc.
- sumatriptanHikma Pharmaceuticals USA Inc.
- Testosterone CypionateCipla USA Inc.
- Testosterone EnanthateHikma Pharmaceuticals USA Inc.
- Valproate Sodiumin shortageHikma Pharmaceuticals USA Inc.
- zoledronic acidHikma Pharmaceuticals USA Inc.
Sources:the establishment's name, address, and country from FDA's Drug Establishments Current Registration Site (DECRS); the drug-to-facility links from DailyMed SPL drug labels, matched by the facility's DUNS number; inspection outcomes from the FDA Data Dashboard, matched by FEI; shortage status from FDA's drug shortage database. More on how this is built. Educational only.