Cambrex Charles City, Inc
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
- United States
- Registered address
- 1205 11th Street, Charles City, Iowa (IA) 50616, United States (USA)
- Operations here
- analysisapi manufacture
- FDA identifiers
- FEI 1000119390 · DUNS 782974257
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2025-03-07
- VAIDrug Quality Assurance2022-05-02
- VAIDrug Quality Assurance2016-12-22
- NAIDrug Quality Assurance2014-02-27
- NAIDrug Quality Assurance2013-08-02
- NAIDrug Quality Assurance2012-02-28
- NAIDrug Quality Assurance2010-03-26
- NAIDrug Quality Assurance2008-10-08
Drugs this plant is listed as making
8 distinct drugs across 41 products name this site in their FDA label.
- Berotralstat hydrochlorideBioCryst Pharmaceuticals, Inc.
- DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATESandoz Inc
- Dextroamphetamine SulfateAmneal Pharmaceuticals of New York LLC
- DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, and AMPHETAMINE SULFATETakeda Pharmaceuticals America, Inc.
- Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine AspartateTakeda Pharmaceuticals America, Inc.
- lisdexamfetamine dimesylatein shortageTakeda Pharmaceuticals America, Inc.
- Sodium ThiosulfateFennec Pharmaceuticals 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.