Pharmaceutical & API manufacturing sites in Denmark
32 drug establishments in Denmark are registered with the US FDA; 20 (63%) list API manufacture among their operations. 21 registrant companies are identified, 1 of them with more than one API site here; sites whose registrant is not resolved to a company profile are not counted. 26 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
- 32
- Registered for API manufacture
- 20
- Identified registrants
- 21
- Current EU/UK GMP match
- 26
Registered operations
| API manufacture | 20 |
| Drug manufacture | 18 |
| Analytical testing | 17 |
| Packaging | 12 |
| Labelling | 10 |
A site can register several operations, so these do not add up to the site total.
Companies headquartered in DenmarkAPI manufacturing sites (20)
- FUJIFILM Diosynth Biotechnologies Denmark ApSHillerodGMP match
- Fertin Pharma A/SVejleGMP match
- Novo Nordisk A/SKalundborgGMP match
- Alk-abello A/sHorsholmGMP match
- Bavarian Nordic A/SKvistgaardGMP match
- Novo Nordisk A/SBagsvaerdGMP match
- Pharmacosmos A/SHolbaekGMP match
- AGC Biologics A/SSoeborgGMP match
- Xellia Pharmaceuticals ApSCopenhagen SGMP match
- Chr. Olesen Synthesis A/SHvidovreGMP match
- Danipharm A/SNIBEGMP match
- BASF A/SBallerupGMP match
- Dansk Salt A/SMariagerGMP match
- H. Lundbeck A/SNykoebing SjGMP match
- Mariager Salt Specialties A/SMariagerGMP match
- Novo Nordisk Pharmatech A/SKogeGMP match
- Syntese A/SHvidovreGMP match
- Biofac A/SLille Skensved
- Novo Nordisk A/S - 25a-BHilleroed
- Novo Nordisk A/S - HaxGentofte
Other sites with EU/UK GMP documents (9)
- Ascendis Pharma A/SHellerupGMP match
- Db Lab A/sOdense SoGMP match
- Eurofins Biopharma Product Testing, Denmark A/SGlostrupGMP match
- GMPack APSHadsundGMP match
- H. Lundbeck A/SValbyGMP match
- LEO Pharma A/SBallerupGMP match
- Particle Analytical ApSHoersholmGMP match
- SmartPractice Denmark ApSHiller�dGMP match
- Zealand Pharma A/SSoeborgGMP 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.