Summit Biosciences 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
- 1513 Bull Lea Road, Lexington, Kentucky (KY) 40511, United States (USA)
- Operations here
- analysislabelmanufacturepack
- FDA identifiers
- FEI 3007577023 · DUNS 832920081
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2025-02-21
- NAIDrug Quality Assurance2020-02-04
- NAIDrug Quality Assurance2017-06-23
- NAIDrug Quality Assurance2015-06-18
Drugs this plant is listed as making
2 distinct drugs across 3 products name this site in their FDA label.
- naloxone HClScienture LLC
- SumatriptanLannett Company, 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.