Is Sanofi Vaccines US Inc. FDA approved?

Sanofi Vaccines US Inc. holds 5 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 Sanofi Vaccines US Inc.'s drugs manufactured?

At registered sites in Canada, France, the United States. The FDA register lists North York; Marcy L Etoile; Neuville-Sur-Saone; VAL-DE-REUIL; Swiftwater, PA. Registered operations: labelling, finished drug manufacture, packaging.

What drugs does Sanofi Vaccines US Inc. make?

25 products are listed under Sanofi Vaccines US Inc. in the openFDA NDC Directory, most often as injection, suspension; injection; injection, solution. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Sanofi Vaccines US Inc.

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

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Registered sites: 5
Active NDC listings: 24
Live patents: 0
Countries: 3
Base: France

Authorisation

Registered operations

Labelling1Finished drug manufacture5Packaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Sanofi Vaccines Canada Ltd.Registrant: Sanofi Vaccines US Inc.	1755 Steeles Ave W, North York, M2R 3T4, Canada (CAN)	Finished drug manufacture	3002888623208206623
Sanofi Winthrop IndustrieRegistrant: Sanofi Vaccines US Inc.	1541 AVENUE MARCEL MERIEUX, Marcy L Etoile, 69280, France (FRA)	Finished drug manufacture	3002972083281659436
Sanofi Winthrop IndustrieRegistrant: Sanofi Vaccines US Inc.	31-33, Neuville-Sur-Saone, 69250, France (FRA)	Finished drug manufacture	3014781447281192839
Sanofi Winthrop IndustrieRegistrant: Sanofi Vaccines US Inc.	VOIE DE L'INSTITUT, VAL-DE-REUIL, 27100, France (FRA)	Finished drug manufacture	3006287395281585696
Sanofi Vaccines US Inc.	1 Discovery Drive, Swiftwater, Pennsylvania (PA) 18370, United States (USA)	Labelling, Finished drug manufacture, Packaging	2518760086723285

Catalogue

Drug listings by form and route

24 active NDC listings: 21 vaccine, 3 human prescription drug. By marketing category: BLA 24.

Dosage form	NDCs
injection, suspension	12
injection	4
injection, solution	4
kit	3
injection, powder, lyophilized, for suspension	1

Route	NDCs
intramuscular	18
subcutaneous	2
intradermal	1

Labeller name on the listing	NDCs
sanofi vaccines us inc.	24

Catalogue

Marketed products

Showing 24 of 25.

Brand	Generic name	Form / route	NDC
ActHIB	HAEMOPHILUS INFLUENZAE TYPE B STRAIN 1482 CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN	kit	49281-545BLA
Adacel TDaP	CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED), CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED), BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED), BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED), BORDETELLA PERTUSSIS PERTACTIN ANTIGEN, and BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGEN	injection, suspension, intramuscular	49281-400BLA
BEYFORTUS	nirsevimab	injection, intramuscular	49281-574BLA
BEYFORTUS	nirsevimab	injection, intramuscular	49281-575BLA
DAPTACEL	corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated), clostridium tetani toxoid antigen (formaldehyde inactivated), bordetella pertussis toxoid antigen (glutaraldehyde inactivated), bordetella pertussis filamentous hemagglutinin antigen (formaldehyde inactivated), bordetella pertussis pertactin antigen, and bordetella pertussis fimbriae 2/3 antigen	injection, suspension, intramuscular	49281-286BLA
Diluent	Sodium Chloride	injection, subcutaneous	49281-912BLA
FLUBLOK TRIVALENT NORTHERN HEMISPHERE	INFLUENZA A VIRUS A/Missouri/11/2025 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN, INFLUENZA A VIRUS A/Darwin/1415/2025 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGEN, and INFLUENZA B VIRUS B/Pennsylvania/14/2025 RECOMBINANT HEMAGGLUTININ ANTIGEN	injection, intramuscular	49281-726BLA
FLUZONE HD TIV SH 2026	INFLUENZA A VIRUS A/SWITZERLAND/6849/2025 IVR-278 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/SINGAPORE/GP20238/2024 IVR-277 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED)	injection, suspension, intramuscular	49281-016BLA
FLUZONE HIGH DOSE NORTHERN HEMISPHERE	INFLUENZA A VIRUS A/SWITZERLAND/6849/2025 IVR-278 (A/MISSOURI/11/2025 PDM09-LIKE VIRUS) (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/MICHIGAN/105/2025 SAN-049A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/TOKYO/EIS13-175/2025 ANTIGEN (FORMALDEHYDE INACTIVATED)	injection, suspension, intramuscular	49281-126BLA
FLUZONE TIV SH 2026	INFLUENZA A VIRUS A/SWITZERLAND/6849/2025 IVR-278 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/SINGAPORE/GP20238/2024 IVR-277 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED)	injection, suspension, intramuscular	49281-315BLA
FLUZONE TIV SH 2026	INFLUENZA A VIRUS A/SWITZERLAND/6849/2025 IVR-278 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/SINGAPORE/GP20238/2024 IVR-277 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED)	injection, suspension, intramuscular	49281-626BLA
FLUZONE TRIVALENT NORTHERN HEMISPHERE	INFLUENZA A VIRUS A/Switzerland/6849/2025 IVR-278 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/Michigan/105/2025 SAN-049A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/Tokyo/EIS13-175/2025 ANTIGEN (FORMALDEHYDE INACTIVATED)	injection, suspension, intramuscular	49281-426BLA
FLUZONE TRIVALENT NORTHERN HEMISPHERE	INFLUENZA A VIRUS A/Switzerland/6849/2025 IVR-278 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/Michigan/105/2025 SAN-049A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/Tokyo/EIS13-175/2025 ANTIGEN (FORMALDEHYDE INACTIVATED)	injection, suspension, intramuscular	49281-645BLA
IMOVAX RABIES	RABIES VIRUS STRAIN PM-1503-3M ANTIGEN (PROPIOLACTONE INACTIVATED) and WATER	kit	49281-252BLA
IPOL	POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED), POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED), and POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED)	injection, suspension, intramuscular	49281-860BLA
MenQuadfi	NEISSERIA MENINGITIDIS GROUP A CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN, NEISSERIA MENINGITIDIS GROUP C CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN, NEISSERIA MENINGITIDIS GROUP Y CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN, and NEISSERIA MENINGITIDIS GROUP W-135 CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN	injection, solution, intramuscular	49281-590BLA
Menactra	NEISSERIA MENINGITIDIS GROUP A CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN, NEISSERIA MENINGITIDIS GROUP C CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN, NEISSERIA MENINGITIDIS GROUP Y CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN, and NEISSERIA MENINGITIDIS GROUP W-135 CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN	injection, solution, intramuscular	49281-589BLA
NUVAXOVID 2026-27	NVX-COV2928	injection, suspension, intramuscular	49281-026BLA
PENTACEL	DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, INACTIVATED POLIOVIRUS AND HAEMOPHILUS B CONJUGATE (TETANUS TOXOID CONJUGATE) VACCINE	kit	49281-511BLA
QUADRACEL	diphtheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine	injection, suspension, intramuscular	49281-564BLA
TENIVAC	CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) and CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)	injection, suspension, intramuscular	49281-215BLA
TUBERSOL	Tuberculin Purified Protein Derivative	injection, solution, intradermal	49281-752BLA
Typhim Vi	SALMONELLA TYPHI TY2 VI POLYSACCHARIDE ANTIGEN	injection, solution, intramuscular	49281-790BLA
YF-VAX	YELLOW FEVER VIRUS STRAIN 17D-204 LIVE ANTIGEN	injection, powder, lyophilized, for suspension, subcutaneous	49281-915BLA

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Enquiry

Common questions

Is Sanofi Vaccines US Inc. FDA approved?: Sanofi Vaccines US Inc. holds 5 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 Sanofi Vaccines US Inc.'s drugs manufactured?: At registered sites in Canada, France, the United States. The FDA register lists North York; Marcy L Etoile; Neuville-Sur-Saone; VAL-DE-REUIL; Swiftwater, PA. Registered operations: labelling, finished drug manufacture, packaging.
What drugs does Sanofi Vaccines US Inc. make?: 25 products are listed under Sanofi Vaccines US Inc. in the openFDA NDC Directory, most often as injection, suspension; injection; 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.