Catalent Indiana, 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
- 1300 S. Patterson Drive, Bloomington, Indiana (IN) 47403, United States (USA)
- Operations here
- analysisapi manufacturelabelmanufacturepack
- FDA identifiers
- FEI 3005949964 · DUNS 172209277
Recent inspection flagged official action
FDA classified an inspection here as OAI (official action indicated) within the last two years — the strongest public warning signal a facility gets. This plant is listed on labels for 6 drugs. A supply problem here can ripple to all of them.
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- OAIDrug Quality Assurance2026-04-24
- OAIDrug Quality Assurance2025-07-14
- VAIDrug Quality Assurance2023-11-15
- VAIVaccines and Allergenic Products2023-11-15
- VAIDrug Quality Assurance2022-09-01
- VAIDrug Quality Assurance2019-10-18
- NAIBlood and Blood Products2018-08-03
- VAIDrug Quality Assurance2018-01-19
- VAIDrug Quality Assurance2017-05-19
- VAIBlood and Blood Products2016-08-24
- NAIDrug Quality Assurance2014-11-07
- VAIDrug Quality Assurance2013-10-25
- NAIDrug Quality Assurance2013-06-17
Drugs this plant is listed as making
6 distinct drugs across 17 products name this site in their FDA label.
- Adalimumab-adbmQuallent Pharmaceuticals Health Llc
- cemiplimab-rwlcRegeneron Pharmaceuticals, Inc.
- efgartigimod alfa and hyaluronidase (human recombinant)argenx US
- Glatiramer AcetateSun Pharmaceutical Industries, Inc.
- tralokinumab-ldrmLEO Pharma 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.