Polygen Pharmaceuticals Inc.
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
- United States
- Registered address
- 41 Mercedes Way, Unit 17, Edgewood, New York (NY) 11717, United States (USA)
- Operations here
- analysislabelmanufacturepackrelabelrepack
- FDA identifiers
- FEI 3008383084 · DUNS 962415720
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2017-12-18
- VAIDrug Quality Assurance2015-03-24
- VAIDrug Quality Assurance2014-08-29
Drugs this plant is listed as making
7 distinct drugs across 10 products name this site in their FDA label.
- amlodipine besylatePolygen Pharmaceuticals Inc.
- clopidogrelPolygen Pharmaceuticals Inc.
- Darifenacin HydrobromidePolygen Pharmaceuticals Inc.
- memantine hydrochloridePolygen Pharmaceuticals Inc.
- Phentermine hydrochloridePolygen 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.