Sindan-Pharma Srl
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
- Romania
- Registered address
- Ion Mihalache Blvd. No. 11, District 1, Bucharest, 011171, Romania (ROU)
- Operations here
- analysislabelmanufacturepack
- FDA identifiers
- FEI 3005566806 · DUNS 683754121
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- NAIBioresearch Monitoring2024-08-02
- VAIDrug Quality Assurance2018-04-05
- VAIDrug Quality Assurance2017-07-28
- NAIDrug Quality Assurance2015-06-15
- NAIDrug Quality Assurance2013-12-10
- NAIDrug Quality Assurance2011-04-06
Drugs this plant is listed as making
1 distinct drugs across 1 products name this site in their FDA label.
- Azacitidinein shortageBluePoint Laboratories
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.