Rommelag CDMO 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
- Bahnhofstr. 18, Sulzbach-Laufen, - 74429, Germany (DEU)
- Operations here
- analysislabelmanufacturepack
- FDA identifiers
- FEI 3002808845 · DUNS 343390324
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2025-03-20
- NAIDrug Quality Assurance2019-09-17
- VAIDrug Quality Assurance2015-10-22
- VAIDrug Quality Assurance2014-02-14
- VAIDrug Quality Assurance2014-02-12
- VAIDrug Quality Assurance2012-02-24
- NAIDrug Quality Assurance2012-02-17
Drugs this plant is listed as making
5 distinct drugs across 5 products name this site in their FDA label.
- Arformoterol tartrateAlembic Pharmaceuticals Inc.
- Formoterol FumarateAlembic Pharmaceuticals Inc.
- Timolol maleateArmas Pharmaceuticals, Inc.
- TobramycinAscend Laboratories, LLC
- Tobramycin Inhalation SolutionDr. Reddy's Laboratories 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.