Zaklady Farmaceutyczne Polpharma 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
- Poland
- Registered address
- Ul. Pelplinska 19, Starogard Gdanski, Pomorskie 83-200, Poland (POL)
- Operations here
- api manufacture
- FDA identifiers
- FEI 3002807920 · DUNS 422195139
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2025-10-17
- VAIDrug Quality Assurance2018-05-25
- NAIDrug Quality Assurance2015-01-29
- NAIDrug Quality Assurance2012-09-20
- NAIDrug Quality Assurance2009-01-29
Drugs this plant is listed as making
1 distinct drugs across 1 products name this site in their FDA label.
- alendronate sodiumRadius Health, 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.