Sintetica S.a.
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
- VIA PENATE 5, MENDRISIO, TI 6850, Switzerland (CHE)
- Operations here
- analysislabelmanufacturepack
- FDA identifiers
- FEI 3004058163 · DUNS 480895478
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2023-11-09
- VAIDrug Quality Assurance2019-05-17
- VAIDrug Quality Assurance2016-12-06
- VAIDrug Quality Assurance2014-11-21
- NAIDrug Quality Assurance2012-11-09
- VAIDrug Quality Assurance2010-10-28
Drugs this plant is listed as making
3 distinct drugs across 4 products name this site in their FDA label.
- AlcoholBPI Labs, LLC
- EpinephrineBPI Labs, LLC
- Phenylephrine hydrochlorideDr. 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.