Nova Laboratories Ltd
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 Kingdom
- Registered address
- Gloucester Cresent, Wigston, Leicestershire LE18 4YL, United Kingdom (GBR)
- Operations here
- manufacture
- FDA identifiers
- FEI 3000323524 · DUNS 230804692
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIHuman Cellular, Tissue, and Gene Therapies2024-08-23
- VAIHuman Cellular, Tissue, and Gene Therapies2019-03-12
- VAIDrug Quality Assurance2019-02-28
- VAIDrug Quality Assurance2016-03-03
- VAIDrug Quality Assurance2013-12-06
Drugs this plant is listed as making
2 distinct drugs across 2 products name this site in their FDA label.
- HydroxyureaNova Laboratories, Ltd.
- voretigene neparvovec-rzylSpark Therapeutics, 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.