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Manufacturing facility

PolyPeptide Laboratories (Sweden) AB

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
Sweden
Registered address
Hogerudsgatan 21, Limhamn, - SE-21613, Sweden (SWE)
Operations here
analysisapi manufacture
FDA identifiers
FEI 3002807004 · DUNS 356580779

FDA inspection history

Outcomes of closed FDA inspections at this site (drug and biologic program areas).

  • VAIDrug Quality Assurance2025-01-23
  • VAIDrug Quality Assurance2019-04-10
  • NAIDrug Quality Assurance2016-05-27
  • VAIDrug Quality Assurance2013-09-20
  • NAIDrug Quality Assurance2009-10-07

Drugs this plant is listed as making

1 distinct drugs across 2 products name this site in their FDA label.

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.