Is Zealand Pharma A/S FDA approved?

Zealand Pharma A/S holds 2 FDA-registered establishments across 2 countries. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.

Where are Zealand Pharma A/S's drugs manufactured?

At registered sites in Denmark, the United States. The FDA register lists Soeborg; Boston, MA. Registered operations: labelling, finished drug manufacture.

Zealand Pharma A/S

Data as of 24 Sept 2026 · How to read this entry

Request a quote Claim this profile

Registered sites: 2
Active NDC listings: 0
Live patents: 4
Exclusivities: 2
Countries: 2
Base: Denmark

Authorisation

Registered operations

Labelling1Finished drug manufacture1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Zealand Pharma A/S	Sydmarken 11, Soeborg, 2860, Denmark (DNK)	Finished drug manufacture	3016672909586358020
Zealand Pharma US, Inc.Registrant: Zealand Pharma A/S	50 Milk St Fl 16, Boston, Massachusetts (MA) 02109-5002, United States (USA)	Labelling	3032326177119319862

Exclusivity

Patents and exclusivities

Patent	Product	Covers	Expiry
11795204	ZEGALOGUE, ZEGALOGUE (AUTOINJECTOR)dasiglucagon hydrochloride	use	Jan 2034
10442847	ZEGALOGUE, ZEGALOGUE (AUTOINJECTOR)dasiglucagon hydrochloride	substance, product	Mar 2035

Product	Exclusivity	Until
ZEGALOGUEDASIGLUCAGON HYDROCHLORIDE	NPP New patient population	Jun 2029
ZEGALOGUE (AUTOINJECTOR)DASIGLUCAGON HYDROCHLORIDE	NPP New patient population	Jun 2029

Neighbours

Registered in the same town

EMD Serono, Inc.Boston, MA
AGC Biologics, Inc.Soeborg, DNK
Spectrum Pharmaceuticals, Inc.Boston, MA
MassBiologicsBoston, MA
BRIGHAM AND WOMEN`S HOSPITAL, INC., THEBoston, MA
Massachusetts General Hospital, TheBoston, MA
Vertex Pharmaceuticals IncorporatedBoston, MA

Compare

Comparable companies in Denmark

Xellia Pharmaceuticals ApS3 sites · 50 NDC
Fertin Pharma A/S1 site · 25 NDC
Pharmacosmos A/S1 site · 10 NDC
A/S Orthana Kemisk Fabrik1 site · 1 NDC
SmartPractice Denmark ApS1 site · 1 NDC
Syntese A/S1 site · 1 NDC
Lundbeck Pharmaceuticals LLC5 sites · 21 NDC
Novo Nordisk Inc.11 sites · 124 NDC

Enquiry

Common questions

Is Zealand Pharma A/S FDA approved?: Zealand Pharma A/S holds 2 FDA-registered establishments across 2 countries. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
Where are Zealand Pharma A/S's drugs manufactured?: At registered sites in Denmark, the United States. The FDA register lists Soeborg; Boston, MA. Registered operations: labelling, finished drug manufacture.

Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.