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Manufacturing facility

Novartis Pharma Stein AG

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
Switzerland
Registered address
Schaffhauserstrasse, Stein, CH-4332, Switzerland (CHE)
Operations here
analysisapi manufacturelabelmanufacturepack
FDA identifiers
FEI 3002653483 · DUNS 488152505

FDA inspection history

Outcomes of closed FDA inspections at this site (drug and biologic program areas).

  • VAIHuman Cellular, Tissue, and Gene Therapies2026-05-19
  • VAIDrug Quality Assurance2024-07-19
  • VAIDrug Quality Assurance2022-12-06
  • VAIVaccines and Allergenic Products2018-12-04
  • VAIDrug Quality Assurance2017-05-09
  • VAIVaccines and Allergenic Products2015-10-16
  • NAIDrug Quality Assurance2015-05-01
  • NAIDrug Quality Assurance2014-03-25
  • VAIDrug Quality Assurance2012-06-22
  • VAIDrug Quality Assurance2010-07-02
  • NAIDrug Quality Assurance2010-03-02
  • NAIDrug Quality Assurance2009-03-27

Drugs this plant is listed as making

2 distinct drugs across 2 products name this site in their FDA label.

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.