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Manufacturing facility

Daiichi Sankyo Europe GmbH

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
Germany
Registered address
Luitpoldstr. 1, Pfaffenhofen a.d.Ilm, Bayern 85276, Germany (DEU)
Operations here
analysislabelmanufacturepack
FDA identifiers
FEI 3003282622 · DUNS 551338593

FDA inspection history

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

  • VAIDrug Quality Assurance2025-07-18
  • NAIDrug Quality Assurance2018-10-19
  • NAIDrug Quality Assurance2014-05-15
  • NAIDrug Quality Assurance2012-09-20
  • NAIDrug Quality Assurance2010-01-29

Drugs this plant is listed as making

1 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.