Apotek Produktion & Laboratorier 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
- Prismavagen 2, Kungens Kurva, SE-141 75, Sweden (SWE)
- Operations here
- analysismanufacture
- FDA identifiers
- FEI 3004967053 · DUNS 776090099
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- NAIDrug Quality Assurance2022-04-28
- VAIDrug Quality Assurance2018-06-01
- VAIDrug Quality Assurance2015-10-13
- VAIDrug Quality Assurance2014-06-13
- NAIDrug Quality Assurance2011-12-15
Drugs this plant is listed as making
1 distinct drugs across 4 products name this site in their FDA label.
- NitisinoneSwedish Orphan Biovitrum Ab (Publ)
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.