BSP Pharmaceuticals SpA
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
- Italy
- Registered address
- Via Appia Km 65,561, Latina Scalo (LT), 04013, Italy (ITA)
- Operations here
- analysisapi manufacturemanufacture
- FDA identifiers
- FEI 3007255826 · DUNS 857007830
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2021-11-12
- VAIDrug Quality Assurance2017-10-20
- VAIDrug Quality Assurance2016-12-16
- VAIDrug Quality Assurance2015-06-26
- VAIDrug Quality Assurance2012-12-05
- NAIDrug Quality Assurance2010-11-12
Drugs this plant is listed as making
4 distinct drugs across 6 products name this site in their FDA label.
- eribulin mesylateEisai Inc.
- gemcitabine intravesicalJanssen Biotech, Inc
- ThiotepaAmneal Pharmaceuticals LLC
- valrubicinEndo USA, 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.