Is Cambrex Karlskoga AB FDA approved?

Cambrex Karlskoga AB holds 1 FDA-registered establishment in Sweden. 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 Cambrex Karlskoga AB's drugs manufactured?

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

What drugs does Cambrex Karlskoga AB make?

13 products are listed under Cambrex Karlskoga AB 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.

Cambrex Karlskoga AB

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

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Registered sites: 1
Active NDC listings: 13
Live patents: 0
Countries: 1
Base: Sweden

Authorisation

Registered operations

Analytical testing1Active ingredient (API) manufacture1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Cambrex Karlskoga AB	Bjorkborns Industriomrade, Karlskoga, - 69185, Sweden (SWE)	Analytical testing, Active ingredient (API) manufacture	3001686607353954043

Catalogue

Drug listings by form and route

13 active NDC listings: 13 bulk ingredient. By marketing category: BULK INGREDIENT 13.

Dosage form	NDCs
powder	13

Route	NDCs

Labeller name on the listing	NDCs
cambrex karlskoga ab	13

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	4-Amiinobenzoic acid	powder	12651-119BULK INGREDIENT
-	BUPIVACAINE HYDROCHLORIDE	powder	12651-111BULK INGREDIENT
-	Benzoyl peroxide, hydrous	powder	12651-115BULK INGREDIENT
-	Berotralstat Dihydrochloride	powder	12651-120BULK INGREDIENT
-	Bupivacaine base	powder	12651-116BULK INGREDIENT
-	LIDOCAINE	powder	12651-124BULK INGREDIENT
-	Lidocaine hydrochloride	powder	12651-113BULK INGREDIENT
-	Mesalamine	powder	12651-582BULK INGREDIENT
-	Momelotinib dihydrochloride monohydrate	powder	12651-123BULK INGREDIENT
-	Olanzapine	powder	12651-125BULK INGREDIENT
-	RIVASTIGMINE	powder	12651-118BULK INGREDIENT
-	Tesofensine/NS2330 citrate	powder	12651-121BULK INGREDIENT
-	Zongertinib	powder	12651-126BULK INGREDIENT

Compare

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Common questions

Is Cambrex Karlskoga AB FDA approved?: Cambrex Karlskoga AB holds 1 FDA-registered establishment in Sweden. 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 Cambrex Karlskoga AB's drugs manufactured?: The FDA register lists Karlskoga. Registered operations: analytical testing, active ingredient (API) manufacture.
What drugs does Cambrex Karlskoga AB make?: 13 products are listed under Cambrex Karlskoga AB 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.