Is Pierre Fabre Pharmaceuticals, Inc. FDA approved?

Pierre Fabre Pharmaceuticals, Inc. holds 3 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 Pierre Fabre Pharmaceuticals, Inc.'s drugs manufactured?

At registered sites in France, the United States. The FDA register lists AIGNAN; Gaillac; Aurora, CO. Registered operations: analytical testing, active ingredient (API) manufacture, finished drug manufacture.

What drugs does Pierre Fabre Pharmaceuticals, Inc. make?

13 products are listed under Pierre Fabre Pharmaceuticals, Inc. in the openFDA NDC Directory, most often as lotion; cream; liquid. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Pierre Fabre Pharmaceuticals, Inc.

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

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Registered sites: 3
Active NDC listings: 13
Labeller names: 2
Live patents: 0
Countries: 2
Base: France

Authorisation

Registered operations

Analytical testing1Active ingredient (API) manufacture1Finished drug manufacture1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
PIERRE FABRE MEDICAMENT PRODUCTIONRegistrant: Pierre Fabre Pharmaceuticals, Inc.	Z I DE LA COUDETTE, AIGNAN, OCCITANIE 32290, France (FRA)	Finished drug manufacture	3006185766291083827
Pierre Fabre MedicamentRegistrant: Pierre Fabre Pharmaceuticals, Inc.	16 rue Jean ROSTAND, Gaillac, Occitanie 81600, France (FRA)	Active ingredient (API) manufacture	3002807889267116254
Pierre Fabre Pharmaceuticals, Inc.	12635 E. Montview Blvd, Aurora, Colorado (CO) 80045, United States (USA)	Analytical testing	3038219610119511544

Catalogue

Drug listings by form and route

13 active NDC listings: 12 human otc drug, 1 human prescription drug. By marketing category: OTC MONOGRAPH DRUG 12, NDA 1.

Dosage form	NDCs
lotion	6
cream	3
liquid	2
solution	1
stick	1

Route	NDCs
topical	12
oral	1

Labeller name on the listing	NDCs
pierre fabre usa inc.	12
pierre fabre pharmaceuticals, inc.	1

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Avene Cleanance Acne Medicated Clearing Gel Cleanser	SALICYLIC ACID	liquid, topical	64760-775OTC MONOGRAPH DRUG
Avene Cleanance Acne Medicated Clearing Treatment	BENZOYL PEROXIDE	liquid, topical	64760-776OTC MONOGRAPH DRUG
Avene Cleanance Mattifying SPF 30	Zinc oxide	lotion, topical	64760-786OTC MONOGRAPH DRUG
Avene Face Sunscreen SPF 50	Zinc oxide	lotion, topical	64760-782OTC MONOGRAPH DRUG
Avene Hydrance Moisturizing SPF 30	Zinc oxide	lotion, topical	64760-783OTC MONOGRAPH DRUG
Avene Mineral Sunscreen Face and Body	ZINC OXIDE	lotion, topical	64760-780OTC MONOGRAPH DRUG
Avene Mineral Sunscreen Stick SPF 50	Zinc oxide	stick, topical	64760-784OTC MONOGRAPH DRUG
Avene Multi-Defense Fluid	Zinc oxide	lotion, topical	64760-778OTC MONOGRAPH DRUG
Avene Multi-Defense Fluid Tinted	Zinc oxide	lotion, topical	64760-779OTC MONOGRAPH DRUG
Avene XERACALM Eczema Calming Relief Balm	Colloidal oatmeal	cream, topical	64760-777OTC MONOGRAPH DRUG
HAUTE PROTECTION High Protection Tinted Compact Broad Spectrum SPF 50 Beige	TITANIUM DIOXIDE, ZINC OXIDE	cream, topical	67015-2036OTC MONOGRAPH DRUG
HAUTE PROTECTION High Protection Tinted Compact Broad Spectrum SPF 50 Honey	TITANIUM DIOXIDE, ZINC OXIDE	cream, topical	67015-2035OTC MONOGRAPH DRUG
HEMANGEOL	propranolol hydrochloride	solution, oral	64370-375NDA

Neighbours

Registered in the same town

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Enquiry

Common questions

Is Pierre Fabre Pharmaceuticals, Inc. FDA approved?: Pierre Fabre Pharmaceuticals, Inc. holds 3 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 Pierre Fabre Pharmaceuticals, Inc.'s drugs manufactured?: At registered sites in France, the United States. The FDA register lists AIGNAN; Gaillac; Aurora, CO. Registered operations: analytical testing, active ingredient (API) manufacture, finished drug manufacture.
What drugs does Pierre Fabre Pharmaceuticals, Inc. make?: 13 products are listed under Pierre Fabre Pharmaceuticals, Inc. in the openFDA NDC Directory, most often as lotion; cream; liquid. 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.