Is Clarochem Ireland Limited FDA approved?

Clarochem Ireland Limited holds 1 FDA-registered establishment in Ireland. 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 Clarochem Ireland Limited's drugs manufactured?

The FDA register lists Dublin. Registered operations: analytical testing, active ingredient (API) manufacture.

What drugs does Clarochem Ireland Limited make?

3 products are listed under Clarochem Ireland Limited in the openFDA NDC Directory, most often as powder. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Clarochem Ireland Limited

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

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Registered sites: 1
Active NDC listings: 3
Labeller names: 2
Live patents: 0
Countries: 1
Base: Ireland

Authorisation

Registered operations

Analytical testing1Active ingredient (API) manufacture1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Clarochem Ireland Limited	Damastown, Mulhuddart, Dublin, D15 DP73, Ireland (IRL)	Analytical testing, Active ingredient (API) manufacture	3010166641988043683

Catalogue

Drug listings by form and route

3 active NDC listings: 3 bulk ingredient. By marketing category: BULK INGREDIENT 2, BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING 1.

Dosage form	NDCs
powder	3

Route	NDCs

Labeller name on the listing	NDCs
clarochem ireland ltd.	2
clarochem ireland ltd	1

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	DROXIDOPA	powder	76278-1120BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
-	Rifaximin	powder	76278-1109BULK INGREDIENT
-	fosfomycin trometamol	powder	76278-1700BULK INGREDIENT

Neighbours

Registered in the same town

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
West Pharmaceutical Services, Inc.Dublin, IRL
Alexion Pharmaceuticals, Inc.Dublin, IRL
LEO Pharma A/SDublin, IRL
LIEBEL-FLARSHEIM COMPANY LLC.Dublin, IRL
HELSINN BIREX PHARMACEUTICALS LIMITEDDublin, IRL

Compare

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Amneal Ireland Limited1 site · 513 NDC
Novo Nordisk Production Ireland Limited1 site · 5 NDC
TOPCHEM PHARMACEUTICALS LIMITED1 site · 5 NDC
Upjohn Manufacturing Ireland Unlimited Company1 site · 2 NDC
MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED1 site · 1 NDC
Eirgen Pharma Ltd1 site · 0 NDC
HELSINN BIREX PHARMACEUTICALS LIMITED1 site · 0 NDC
NORTON (WATERFORD) LIMITED1 site · 0 NDC
IPSEN MANUFACTURING IRELAND LIMITED2 sites · 17 NDC
SK BIOTEK2 sites · 10 NDC

Enquiry

Common questions

Is Clarochem Ireland Limited FDA approved?: Clarochem Ireland Limited holds 1 FDA-registered establishment in Ireland. 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 Clarochem Ireland Limited's drugs manufactured?: The FDA register lists Dublin. Registered operations: analytical testing, active ingredient (API) manufacture.
What drugs does Clarochem Ireland Limited make?: 3 products are listed under Clarochem Ireland Limited in the openFDA NDC Directory, most often as powder. 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.