Pharmaceutical & API manufacturing sites in Sweden
26 drug establishments in Sweden are registered with the US FDA; 9 (35%) list API manufacture among their operations. 17 registrant companies are identified; sites whose registrant is not resolved to a company profile are not counted. 20 published sites are matched to an EU or UK GMP certificate inspected within the last three years.
Counts are physical site addresses in the FDA's current establishment register (US-facing sites only), not headquarters and not production volume. Methodology
- FDA-registered sites
- 26
- Registered for API manufacture
- 9
- Identified registrants
- 17
- Current EU/UK GMP match
- 20
Registered operations
| Analytical testing | 24 |
| Drug manufacture | 15 |
| Labelling | 9 |
| Packaging | 9 |
| API manufacture | 9 |
| Relabelling | 2 |
A site can register several operations, so these do not add up to the site total.
Companies headquartered in SwedenAPI manufacturing sites (9)
- Q-Med ABUppsalaGMP match
- AstraZeneca ABSodertaljeGMP match
- Fresenius Kabi ABUppsalaGMP match
- Fresenius Kabi ABKungsangenGMP match
- Pfizer Health ABStrangnasGMP match
- AAK Sweden ABKarlshamnGMP match
- PolyPeptide Laboratories (Sweden) ABLimhamnGMP match
- Cambrex Karlskoga ABKarlskoga
- Recipharm Uppsala ABUppsala
Other sites with EU/UK GMP documents (13)
- ALS Scandinavia ABLuleaGMP match
- Apotek Produktion & Laboratorier ABKungens KurvaGMP match
- Apotek Produktion & Laboratorier ABMalmoGMP match
- Apotek Produktion & Laboratorier ABUmeaGMP match
- AstraZeneca ABSodertaljeGMP match
- Eurofins BioPharma Product Testing Sweden ABUppsalaGMP match
- Eurofins BioPharma Product Testing Sweden ABUppsalaGMP match
- McNeil ABHelsingborgGMP match
- Mikrolab Stockholm ABSollentunaGMP match
- Novavax ABUppsalaGMP match
- Octapharma ABStockholmGMP match
- Rechon Life Science ABLimhamnGMP match
- Zelmic ABLundGMP match
Only sites registered with the US FDA appear, so manufacturing that serves only other markets is missing and these figures understate national capacity. A GMP match requires the certificate address to name the site's street and its city or postcode; an unmatched site is not an uncertified site.