Register entry
Sanofi Vaccines US Inc.
- Registered sites
- 5
- Drug products
- 24
- Live patents
- 0
- Countries
- 3
- Base
- France
Authorisation
Registered operations
What the FDA has registered these sites to do. This is the regulatory record, not a marketing claim.
LabellingFinished drug manufacturePackaging
Sites
Facilities
5| Site | Location | Operations | FEI |
|---|---|---|---|
| Sanofi Vaccines Canada Ltd. | North YorkCanada | Finished drug manufacture | 3002888623 |
| Sanofi Winthrop Industrie | Marcy L EtoileFrance | Finished drug manufacture | 3002972083 |
| Sanofi Winthrop Industrie | Neuville-Sur-SaoneFrance | Finished drug manufacture | 3014781447 |
| Sanofi Winthrop Industrie | VAL-DE-REUILFrance | Finished drug manufacture | 3006287395 |
| Sanofi Vaccines US Inc. | Swiftwater, PAUnited States | Labelling, Finished drug manufacture, Packaging | 2518760 |
Catalogue
Marketed products
24Showing 24 of 24.
| Brand | Generic name | Form | Category |
|---|---|---|---|
| ActHIB | HAEMOPHILUS INFLUENZAE TYPE B STRAIN 1482 CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN | KIT | BLA |
| 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 | BLA |
| BEYFORTUS | nirsevimab | INJECTION | BLA |
| BEYFORTUS | nirsevimab | INJECTION | BLA |
| 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 | BLA |
| Dengvaxia | Dengue Tetravalent Vaccine, Live | KIT | BLA |
| Diluent | Sodium Chloride | INJECTION | BLA |
| 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 | BLA |
| 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 | BLA |
| 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 | BLA |
| 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 | BLA |
| 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 | BLA |
| 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 | BLA |
| 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 | BLA |
| IMOVAX RABIES | RABIES VIRUS STRAIN PM-1503-3M ANTIGEN (PROPIOLACTONE INACTIVATED) and WATER | KIT | BLA |
| IPOL | POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED), POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED), and POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED) | INJECTION, SUSPENSION | BLA |
| 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 | BLA |
| 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 | BLA |
| PENTACEL | DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, INACTIVATED POLIOVIRUS AND HAEMOPHILUS B CONJUGATE (TETANUS TOXOID CONJUGATE) VACCINE | KIT | BLA |
| QUADRACEL | diphtheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine | INJECTION, SUSPENSION | BLA |
| TENIVAC | CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) and CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) | INJECTION, SUSPENSION | BLA |
| TUBERSOL | Tuberculin Purified Protein Derivative | INJECTION, SOLUTION | BLA |
| Typhim Vi | SALMONELLA TYPHI TY2 VI POLYSACCHARIDE ANTIGEN | INJECTION, SOLUTION | BLA |
| YF-VAX | YELLOW FEVER VIRUS STRAIN 17D-204 LIVE ANTIGEN | INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION | BLA |
Provenance
Facility and operations data from the FDA Drug Establishments Current Registration Site. Product data from the openFDA National Drug Code Directory. Patent and exclusivity data from the FDA Orange Book. Shortage data from the FDA drug shortage database. Contact details the FDA publishes for registered establishments are deliberately not reproduced here. This entry is compiled from public records and has not been claimed by the company.