Catalent Pharma Solutions, LLC
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
- 1100 Enterprise Drive, Winchester, Kentucky (KY) 40391, United States (USA)
- Operations here
- analysislabelmanufacturepack
- FDA identifiers
- FEI 1000122400 · DUNS 829672745
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2025-04-22
- VAIDrug Quality Assurance2023-01-11
- NAIDrug Quality Assurance2017-11-15
- NAIDrug Quality Assurance2017-05-04
- NAIDrug Quality Assurance2014-06-27
- VAIDrug Quality Assurance2013-02-05
- NAIDrug Quality Assurance2012-11-14
- NAIDrug Quality Assurance2012-04-19
- NAIDrug Quality Assurance2011-04-21
- VAIDrug Quality Assurance2008-12-09
Drugs this plant is listed as making
11 distinct drugs across 30 products name this site in their FDA label.
- Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine SulfateAmneal Pharmaceuticals of New York LLC
- dextroamphetamine sulfateAmneal Pharmaceuticals LLC
- DoxycyclineMayne Pharma Inc.
- doxycycline hyclateAqua Pharmaceuticals
- lofexidine hydrochloridePrasco Laboratories
- mesalamineTeva Pharmaceuticals USA, Inc.
- phentermine and topiramateVivus LLC
- tecovirimat monohydrateSIGA Technologies, Inc.
- TobramycinAmneal Pharmaceuticals LLC
- TopiramateUpsher-Smith Laboratories, LLC
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.