Haupt Pharma Amareg 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
- Donaustaufer Str. 378, Regensburg, Bavaria 93055, Germany (DEU)
- Operations here
- analysislabelmanufacturepack
- FDA identifiers
- FEI 3008293991 · DUNS 331334909
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2024-07-26
- VAIDrug Quality Assurance2019-06-07
- VAIDrug Quality Assurance2017-11-10
- VAIDrug Quality Assurance2016-08-26
- NAIDrug Quality Assurance2013-11-22
Drugs this plant is listed as making
2 distinct drugs across 2 products name this site in their FDA label.
- miltefosineProfounda, Inc.
- TriheptanoinUltragenyx Pharmaceutical 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.