HP Halden Pharma AS
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
- Norway
- Registered address
- Svinesundsveien 80, Halden, OSTFOLD NO-1788, Norway (NOR)
- Operations here
- analysismanufacturepack
- FDA identifiers
- FEI 3002608066 · DUNS 347747373
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2023-05-10
- VAIDrug Quality Assurance2019-09-03
- VAIDrug Quality Assurance2017-05-26
- VAIDrug Quality Assurance2015-06-26
- VAIDrug Quality Assurance2013-12-20
- VAIDrug Quality Assurance2012-08-23
- VAIDrug Quality Assurance2009-11-17
Drugs this plant is listed as making
26 distinct drugs across 69 products name this site in their FDA label.
- AcetaminophenFresenius Kabi USA, LLC
- Calcium GluconateFresenius Kabi USA, LLC
- Dextrose Monohydratein shortageFresenius Kabi USA, LLC
- DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDEFresenius Kabi USA, LLC
- Heparin Sodiumin shortageFresenius Kabi USA, LLC
- LevetiracetamHp Halden Pharma AS
- LevofloxacinFresenius Kabi USA, LLC
- Lidocaine Hydrochloridein shortageFresenius Kabi USA, LLC
- LinezolidFresenius Kabi USA, LLC
- Magnesium Sulfate HeptahydrateFresenius Kabi USA, LLC
- Moxifloxacin HydrochlorideFresenius Kabi USA, LLC
- Potassium ChlorideFresenius Kabi USA, LLC
- Potassium Chloride, Dextrose MonohydrateFresenius Kabi USA, LLC
- POTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM LACTATE, and DEXTROSE MONOHYDRATEFresenius Kabi USA, LLC
- Ropivacaine Hydrochloridein shortageFresenius Kabi USA, LLC
- Sodium ChlorideBecton Dickinson and Company
- Sodium Chloride and Potassium ChlorideFresenius Kabi USA, LLC
- Sodium Chloride, Sodium Lactate, Potassium Chloride, Calcium ChlorideFresenius Kabi USA, LLC
- SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, and DEXTROSE MONOHYDRATEFresenius Kabi USA, LLC
- Tranexamic AcidHP Halden Pharma AS
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.