Catalent Germany Schorndorf 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
- Steinbeisstrasse 1-2, Schorndorf, - D-73614, Germany (DEU)
- Operations here
- analysislabelmanufacturepack
- FDA identifiers
- FEI 3003831171 · DUNS 315732628
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2022-03-17
- VAIDrug Quality Assurance2020-02-14
- VAIDrug Quality Assurance2018-09-21
- VAIDrug Quality Assurance2016-10-26
- NAIDrug Quality Assurance2014-02-07
- NAIDrug Quality Assurance2012-02-10
- VAIDrug Quality Assurance2009-09-03
Drugs this plant is listed as making
4 distinct drugs across 10 products name this site in their FDA label.
- dabigatran etexilateBoehringer Ingelheim Pharmaceuticals, Inc.
- DUTASTERIDE and TAMSULOSIN HYDROCHLORIDEWaylis Therapeutics
- efbemalenograstim alfa-vuxwAcrotech Biopharma Inc
- lanthanum carbonateTakeda Pharmaceuticals America, 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.