Quimica Sintetica Sa
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
- Spain
- Registered address
- CALLE DULCINEA, S/N, ALCALA DE HENARES, 28805, Spain (ESP)
- Operations here
- analysisapi manufacture
- FDA identifiers
- FEI 3002807965 · DUNS 460054141
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2022-04-06
- VAIDrug Quality Assurance2019-03-22
- VAIDrug Quality Assurance2016-09-09
- NAIDrug Quality Assurance2013-10-31
- VAIDrug Quality Assurance2010-07-08
Drugs this plant is listed as making
1 distinct drugs across 4 products name this site in their FDA label.
- guanfacineTakeda Pharmaceuticals America, 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.