Is Fertin Pharma A/S FDA approved?

Fertin Pharma A/S holds 1 FDA-registered establishment in Denmark. 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 Fertin Pharma A/S's drugs manufactured?

The FDA register lists Vejle. Registered operations: analytical testing, active ingredient (API) manufacture, finished drug manufacture, packaging.

What drugs does Fertin Pharma A/S make?

25 products are listed under Fertin Pharma A/S in the openFDA NDC Directory, most often as gum, chewing; lozenge. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Fertin Pharma A/S

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

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Registered sites: 1
Active NDC listings: 25
Live patents: 0
Countries: 1
Base: Denmark

Authorisation

Registered operations

Analytical testing1Active ingredient (API) manufacture1Finished drug manufacture1Packaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Fertin Pharma A/S	Dandyvej 19, Vejle, - 7100, Denmark (DNK)	Analytical testing, Active ingredient (API) manufacture, Finished drug manufacture, Packaging	3003029369307046859

Catalogue

Drug listings by form and route

25 active NDC listings: 24 drug for further processing, 1 human otc drug. By marketing category: DRUG FOR FURTHER PROCESSING 24, ANDA 1.

Dosage form	NDCs
gum, chewing	19
lozenge	6

Route	NDCs
buccal	1

Labeller name on the listing	NDCs
fertin pharma a/s	25

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	Nicotine Polacrilex	gum, chewing	63443-0838DRUG FOR FURTHER PROCESSING
-	Nicotine Polacrilex	gum, chewing	63443-0839DRUG FOR FURTHER PROCESSING
-	Nicotine Polacrilex	lozenge	63443-3676DRUG FOR FURTHER PROCESSING
-	Nicotine Polacrilex	lozenge	63443-3677DRUG FOR FURTHER PROCESSING
-	Nicotine Polacrilex	lozenge	63443-3678DRUG FOR FURTHER PROCESSING
-	Nicotine Polacrilex	lozenge	63443-3679DRUG FOR FURTHER PROCESSING
Nicotine Polacrilex Gum	Nicotine Polacrilex	gum, chewing, buccal	63443-5057ANDA
-	Nicotine Polacrilex Lozenges 2mg Mint	lozenge	63443-3675DRUG FOR FURTHER PROCESSING
-	Nicotine Polacrilex Lozenges 4 mg Mint	lozenge	63443-3670DRUG FOR FURTHER PROCESSING
-	nicotine polacrilex	gum, chewing	63443-0101DRUG FOR FURTHER PROCESSING
-	nicotine polacrilex	gum, chewing	63443-0102DRUG FOR FURTHER PROCESSING
-	nicotine polacrilex	gum, chewing	63443-0121DRUG FOR FURTHER PROCESSING
-	nicotine polacrilex	gum, chewing	63443-0201DRUG FOR FURTHER PROCESSING
-	nicotine polacrilex	gum, chewing	63443-0202DRUG FOR FURTHER PROCESSING
-	nicotine polacrilex	gum, chewing	63443-0221DRUG FOR FURTHER PROCESSING
-	nicotine polacrilex	gum, chewing	63443-1032DRUG FOR FURTHER PROCESSING
-	nicotine polacrilex	gum, chewing	63443-1033DRUG FOR FURTHER PROCESSING
-	nicotine polacrilex	gum, chewing	63443-1151DRUG FOR FURTHER PROCESSING
-	nicotine polacrilex	gum, chewing	63443-1152DRUG FOR FURTHER PROCESSING
-	nicotine polacrilex	gum, chewing	63443-1560DRUG FOR FURTHER PROCESSING
-	nicotine polacrilex	gum, chewing	63443-1561DRUG FOR FURTHER PROCESSING
-	nicotine polacrilex	gum, chewing	63443-2853DRUG FOR FURTHER PROCESSING
-	nicotine polacrilex	gum, chewing	63443-2854DRUG FOR FURTHER PROCESSING
-	nicotine polacrilex	gum, chewing	63443-5080DRUG FOR FURTHER PROCESSING
-	nicotine polacrilex	gum, chewing	63443-5081DRUG FOR FURTHER PROCESSING

Compare

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SmartPractice Denmark ApS1 site · 1 NDC
Syntese A/S1 site · 1 NDC
Zealand Pharma A/S2 sites · 0 NDC
Xellia Pharmaceuticals ApS3 sites · 50 NDC
Lundbeck Pharmaceuticals LLC5 sites · 21 NDC

Enquiry

Common questions

Is Fertin Pharma A/S FDA approved?: Fertin Pharma A/S holds 1 FDA-registered establishment in Denmark. 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 Fertin Pharma A/S's drugs manufactured?: The FDA register lists Vejle. Registered operations: analytical testing, active ingredient (API) manufacture, finished drug manufacture, packaging.
What drugs does Fertin Pharma A/S make?: 25 products are listed under Fertin Pharma A/S in the openFDA NDC Directory, most often as gum, chewing; lozenge. 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.