Apace Packaging 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
- 12954 Fountain Run Road, Fountain Run, Kentucky (KY) 42133, United States (USA)
- Operations here
- labelpackrelabelrepack
- FDA identifiers
- FEI 3005336862 · DUNS 361961142
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- NAIDrug Quality Assurance2022-01-13
- VAIDrug Quality Assurance2016-08-04
- NAIDrug Quality Assurance2013-07-30
- NAIDrug Quality Assurance2012-08-24
- VAIDrug Quality Assurance2011-09-23
- VAIDrug Quality Assurance2008-12-11
Drugs this plant is listed as making
21 distinct drugs across 61 products name this site in their FDA label.
- Amphetamine Sulfate TabletsDr. Reddy's Laboratories Inc
- Betaine AnhydrousEton Pharmaceuticals, Inc.
- dexlansoprazoleUpsher-Smith Laboratories, LLC
- Diltiazem hydrochlorideUpsher-Smith Laboratories, LLC
- dimethyl fumarateUpsher-Smith Laboratories, LLC
- Donepezil HydrochlorideUpsher-Smith Laboratories, LLC
- DronabinolAscend Laboratories, LLC
- Duloxetine HydrochlorideBreckenridge Pharmaceutical, Inc.
- Fluphenazine HydrochlorideUpsher-Smith Laboratories, LLC
- GuanfacineUpsher-Smith Laboratories, LLC
- HydrocortisoneEton Pharmaceuticals, Inc.
- LubiprostoneNatco Pharma USA LLC
- Megestrol AcetateUpsher-Smith Laboratories, LLC
- mycophenolic acidUpsher-Smith Laboratories, LLC
- NifedipineUpsher-Smith Laboratories, LLC
- omeprazoleLannett Company, Inc.
- propranolol hydrochloridein shortageBreckenridge Pharmaceutical, Inc.
- Sevelamer CarbonateTWi Pharmaceuticals, Inc.
- Terbinafine HydrochlorideBreckenridge Pharmaceutical, Inc.
- Terbutaline SulfateUpsher-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.