Is LEO Pharma A/S FDA approved?

LEO Pharma A/S holds 3 FDA-registered establishments across 3 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 LEO Pharma A/S's drugs manufactured?

At registered sites in Denmark, Ireland, Italy. The FDA register lists Ballerup; Dublin; Segrate. Registered operations: analytical testing, labelling, finished drug manufacture, packaging.

What drugs does LEO Pharma A/S make?

9 products are listed under LEO Pharma A/S in the openFDA NDC Directory, most often as injection; aerosol, foam; injection, solution. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

LEO Pharma A/S

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

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Registered sites: 3
Active NDC listings: 9
Labeller names: 2
Live patents: 38
Exclusivities: 1
Countries: 3
Base: Ireland

Authorisation

Registered operations

Analytical testing3Labelling3Finished drug manufacture3Packaging3

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
LEO Pharma A/S	Industriparken 55, Ballerup, Region Hovedstaden 2750, Denmark (DNK)	Analytical testing, Labelling, Finished drug manufacture, Packaging	3002807496306218108
LEO Laboratories Ltd.Registrant: LEO Pharma A/S	285 Cashel Road, Crumlin, Dublin, Dublin 12, Ireland (IRL)	Analytical testing, Labelling, Finished drug manufacture, Packaging	3002807468219532322
Leo Pharma Manufacturing Italy SRL.Registrant: LEO Pharma A/S	VIA Ernest Schering 21, Segrate, Milano 20054, Italy (ITA)	Analytical testing, Labelling, Finished drug manufacture, Packaging	3002808260439982002

Catalogue

Drug listings by form and route

9 active NDC listings: 9 human prescription drug. By marketing category: BLA 5, NDA 4.

Dosage form	NDCs
injection	3
aerosol, foam	2
injection, solution	2
cream	1
suspension	1

Route	NDCs
subcutaneous	5
topical	4

Labeller name on the listing	NDCs
leo pharma inc.	8
leo pharma, inc	1

Exclusivity

Patents and exclusivities

Patent	Product	Covers	Expiry
8372827	PICATOingenol mebutate	product	Dec 2026
8372828	PICATOingenol mebutate	product	Dec 2026
8377919	PICATOingenol mebutate	product	Dec 2026
8536163	PICATOingenol mebutate	use	Dec 2026
8716271	PICATOingenol mebutate	use	Dec 2026
8735375	PICATOingenol mebutate	use	Dec 2026
9820959	PICATOingenol mebutate	product	Dec 2026
9833428	PICATOingenol mebutate	product	Dec 2026
9833429	PICATOingenol mebutate	product	Dec 2026
9861603	PICATOingenol mebutate	use	Dec 2026
8278292	PICATOingenol mebutate	product	Jul 2027
7700076	FINACEAazelaic acid	product	Sept 2027
10117812	FINACEAazelaic acid	product	Oct 2027
9265725	FINACEAazelaic acid	product	Dec 2027
9211259	FINACEAazelaic acid	use	Feb 2029
10130640	ENSTILARbetamethasone dipropionate; calcipotriene	product	Jun 2031
10617698	ENSTILARbetamethasone dipropionate; calcipotriene	product	Jun 2031
10660908	ENSTILARbetamethasone dipropionate; calcipotriene	product	Jun 2031
10682364	ENSTILARbetamethasone dipropionate; calcipotriene	product	Jun 2031
10688108	ENSTILARbetamethasone dipropionate; calcipotriene	use	Jun 2031
10716799	ENSTILARbetamethasone dipropionate; calcipotriene	product	Jun 2031
9119781	ENSTILARbetamethasone dipropionate; calcipotriene	product	Jun 2031
9566286	ENSTILARbetamethasone dipropionate; calcipotriene	product	Jun 2031
8609647	ANZUPGOdelgocitinib	substance, product	Sept 2031
10130640*PED	ENSTILARbetamethasone dipropionate; calcipotriene	use	Dec 2031
9119781*PED	ENSTILARbetamethasone dipropionate; calcipotriene	use	Dec 2031
9789078	PICATOingenol mebutate	use	May 2033

Product	Exclusivity	Until
ANZUPGODELGOCITINIB	NCE New chemical entity	Jul 2030

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Adbry	tralokinumab-ldrm	injection, solution, subcutaneous	50222-346BLA
Adbry	tralokinumab-ldrm	injection, solution, subcutaneous	50222-350BLA
Anzupgo	delgocitinib	cream, topical	50222-280NDA
ENSTILAR	calcipotriene and betamethasone dipropionate	aerosol, foam, topical	50222-302NDA
FINACEA FOAM	azelaic acid	aerosol, foam, topical	50222-303NDA
SPEVIGO	spesolimab	injection, subcutaneous	50222-360BLA
SPEVIGO	spesolimab	injection, subcutaneous	50222-361BLA
SPEVIGO	spesolimab	injection, subcutaneous	50222-362BLA
TACLONEX	calcipotriene and betamethasone dipropionate	suspension, topical	50222-501NDA

Neighbours

Registered in the same town

Olon USA LLCSegrate, ITA
Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.Dublin, IRL
Astellas Pharma US, Inc.DUBLIN, IRL
Allergan, Inc.Dublin, IRL
Takeda Pharmaceuticals U.S.A., Inc.Dublin, IRL
BASF CorporationBallerup, DNK
West Pharmaceutical Services, Inc.Dublin, IRL
Alexion Pharmaceuticals, Inc.Dublin, IRL
LIEBEL-FLARSHEIM COMPANY LLC.Dublin, IRL
Clarochem Ireland LimitedDublin, IRL
Delpharm Milano SrlSegrate, ITA
HELSINN BIREX PHARMACEUTICALS LIMITEDDublin, IRL

Compare

Comparable companies in Ireland

Alexion Pharmaceuticals, Inc.3 sites · 10 NDC
Jazz Pharmaceuticals Operations UK Limited3 sites · 9 NDC
IPSEN MANUFACTURING IRELAND LIMITED2 sites · 17 NDC
SK BIOTEK2 sites · 10 NDC
LIEBEL-FLARSHEIM COMPANY LLC.2 sites · 7 NDC
Eurofins BioPharma Product Testing India Private Limited4 sites · 0 NDC
Q1 Scientific Ltd2 sites · 0 NDC
Amneal Ireland Limited1 site · 513 NDC
Novo Nordisk Production Ireland Limited1 site · 5 NDC
Clarochem Ireland Limited1 site · 3 NDC

Enquiry

Common questions

Is LEO Pharma A/S FDA approved?: LEO Pharma A/S holds 3 FDA-registered establishments across 3 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 LEO Pharma A/S's drugs manufactured?: At registered sites in Denmark, Ireland, Italy. The FDA register lists Ballerup; Dublin; Segrate. Registered operations: analytical testing, labelling, finished drug manufacture, packaging.
What drugs does LEO Pharma A/S make?: 9 products are listed under LEO Pharma A/S in the openFDA NDC Directory, most often as injection; aerosol, foam; injection, solution. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

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.