Catalent Maryland, 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
- 7555 Harmans Road, Harmans, Maryland (MD) 21077, United States (USA)
- Operations here
- analysisapi manufacturemanufacture
- FDA identifiers
- FEI 3015434301 · DUNS 116950534
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- NAIHuman Cellular, Tissue, and Gene Therapies2024-11-15
- VAIVaccines and Allergenic Products2023-03-10
- NAIHuman Cellular, Tissue, and Gene Therapies2023-01-24
- VAIHuman Cellular, Tissue, and Gene Therapies2021-11-17
- VAIVaccines and Allergenic Products2021-11-17
Drugs this plant is listed as making
1 distinct drugs across 1 products name this site in their FDA label.
- zopapogene imadenovecPrecigen, 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.