Bachem 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
- Hauptstrasse 144, Bubendorf, 4416, Switzerland (CHE)
- Operations here
- analysisapi manufacture
- FDA identifiers
- FEI 1000153019 · DUNS 482220311
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2024-08-16
- NAIDrug Quality Assurance2017-11-17
- NAIDrug Quality Assurance2014-02-14
- NAIDrug Quality Assurance2010-09-29
Drugs this plant is listed as making
3 distinct drugs across 4 products name this site in their FDA label.
- GlucagonCipla USA Inc.
- PegcetacoplanApellis Pharmaceuticals, Inc.
- sincalideBracco Diagnostics 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.