Haupt Pharma Wuelfing 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
- Bethelner Landstraße 18, Gronau (Leine), - 31028, Germany (DEU)
- Operations here
- analysislabelmanufacturepack
- FDA identifiers
- FEI 3003183252 · DUNS 333274975
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2023-06-06
- NAIDrug Quality Assurance2018-12-07
- NAIDrug Quality Assurance2017-03-17
- VAIDrug Quality Assurance2014-03-28
- VAIDrug Quality Assurance2012-04-20
- VAIDrug Quality Assurance2008-11-06
Drugs this plant is listed as making
2 distinct drugs across 3 products name this site in their FDA label.
- bosentanActelion Pharmaceuticals US, Inc.
- Prussian blue insoluble capsulesHeyl Chem.-pharm. Fabrik GmbH & Co. KG
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.