Ophtapharm 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
- Riethofstrasse 1, Hettlingen, 8442, Switzerland (CHE)
- Operations here
- analysislabelmanufacturepack
- FDA identifiers
- FEI 3005531475 · DUNS 482198285
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2020-02-28
- VAIDrug Quality Assurance2017-12-12
- VAIDrug Quality Assurance2016-05-25
- VAIDrug Quality Assurance2014-03-28
- VAIDrug Quality Assurance2011-11-09
Drugs this plant is listed as making
7 distinct drugs across 14 products name this site in their FDA label.
- Brimonidine Tartrate and Timolol MaleateArmas Pharmaceuticals Inc
- BromfenacArmas Pharmaceuticals Inc.
- Ciprofloxacin and dexamethasoneArmas Pharmaceuticals Inc.
- ErythromycinSentiss Pharmaceuticals LLC
- Lidocaine Hydrochloridein shortageArmas Pharmaceuticals Inc.
- Loteprednol EtabonateSentiss Pharmaceuticals LLC
- OfloxacinArmas Pharmaceuticals 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.