Pharmaceutical & API manufacturing sites in United States
5,394 drug establishments in United States are registered with the US FDA; 513 (10%) list API manufacture among their operations. 3,052 registrant companies are identified, 64 of them with more than one API site here; sites whose registrant is not resolved to a company profile are not counted. 62 published sites are matched to an EU or UK GMP certificate inspected within the last three years.
Counts are physical site addresses in the FDA's current establishment register (US-facing sites only), not headquarters and not production volume. Methodology
- FDA-registered sites
- 5,394
- Registered for API manufacture
- 513
- Identified registrants
- 3,052
- Current EU/UK GMP match
- 62
Registered operations
| Drug manufacture | 3,131 |
| Analytical testing | 1,070 |
| Labelling | 933 |
| Packaging | 839 |
| Medicated animal feed | 688 |
| Repackaging | 688 |
| API manufacture | 513 |
| Relabelling | 500 |
| Transfilling (medical gases) | 156 |
| PET drug production | 151 |
| Sterilisation | 81 |
| Distribution | 16 |
A site can register several operations, so these do not add up to the site total.
Companies headquartered in United StatesAPI manufacturing sites (513)
- AldevronFargoGMP match
- FUJIFILM Diosynth Biotechnologies California, Inc.Thousand OaksGMP match
- Genezen MA, Inc.LexingtonGMP match
- Merck Sharp & Dohme LLCElktonGMP match
- AbbVie Inc.North ChicagoGMP match
- BAXALTA US INC.LOS ANGELESGMP match
- Bayer HealthCare LLCBerkeleyGMP match
- Catalent Maryland, Inc.HarmansGMP match
- Catalent Pharma Solutions, LLCMadisonGMP match
- CELGENE CORPORATIONSUMMITGMP match
- Eurofins Advantar Laboratories, LLCSan DiegoGMP match
- Janssen Biotech, Inc.MalvernGMP match
- Juno Therapeutics, Inc.BothellGMP match
- Kashiv BioSciences, LLCPiscatawayGMP match
- Lonza Biologics, Inc.PortsmouthGMP match
- Merck Sharp & Dohme LLCWest PointGMP match
- ModernaTX, Inc.NorwoodGMP match
- Patheon Biologics LLCSaint LouisGMP match
- Precigen, Inc.GermantownGMP match
- SHINE Technologies, LLCJanesvilleGMP match
- Spark Therapeutics, Inc.PhiladelphiaGMP match
- Zoetis LLCLincolnGMP match
- 3A LLCPerrysburg
- A + OXYGEN & D.M.E.Reno
- AAA Molybdenum Products, Inc.Broomfield
- Abbey Color IncorporatedPhiladelphia
- AbbVie Bioresearch CenterWorcester
- AbbVie Biotechnology LTDBarceloneta
- AbbVie Inc.Wyandotte
- Abeona Therapeutics Inc.Cleveland
- Adare Pharmaceuticals, Inc.Vandalia
- Adicet Therapeutics, Inc.Redwood City
- Advanced Accelerator Applications USA, Inc.Millburn
- Advanced BiotechTotowa
- Advanced Skin Technologies Inc.Bernville
- AGC Biologics Inc.Longmont
- AGC Biologics Inc.Boulder
- AGC Biologics, Inc.Bothell
- Agilent Technologies, Inc.Boulder
- Agilent Technologies, Inc.Frederick
- AgroChem USA, LLCSaratoga Springs
- Air Liquide Electronics U.S. LPMorrisville
- AIRGAS USA, LLCPlumsteadville
- Ajinomoto Health & Nutrition North America, Inc.Raleigh
- Ajinomoto Health & Nutrition North America, Inc.Eddyville
- AJNA BioSciences PBCLittleton
- Albemarle U.S. IncKings Mountain
- ALCHEM LABORATORIES CORPORATIONALACHUA
- Aldrich Chemical Company LLCMiamisburg
- ALK-ABELLO, INC.Plainville
- Allergan Sales, LLCCampbell
- Allergan Sales, LLCIrvine
- Alnylam US Inc.Norton
- Altaire Pharmaceuticals Inc.Aquebogue
- Alternative Meds Inc.Greeley
- Alto ICP, LLCPekin
- Ambiopharm, Inc.North Augusta
- American Distilling Inc.East Hampton
- American Laboratories Pharma, LLCOmaha
- Ames Goldsmith CorpGlens Falls
- Amgen Manufacturing Limited LLCJuncos
- Amgen, IncThousand Oaks
- Amino Cell, Inc.Ocala
- AMPAC Fine Chemicals LLCRANCHO CORDOVA
- AMPAC Fine Chemicals Texas LLCLa Porte
- AnaSpec Inc.Fremont
- Andelyn Biosciences, Inc.Columbus
- AndersonBrecon Inc.Rockford
- AndersonBrecon Inc.Rockford
- Anesis Life, LLCMacomb
- Animal Science Products Inc.Nacogdoches
- API, Inc.Fairfield
- Apicore US LLCEast Windsor Township
- Apotheca IncGainesville
- Applechem, Inc.Parsippany
- Aprecia Pharmaceuticals, LLCMason
- ARCH CHEMICALS, INC.Rochester
- Argenta US Manufacturing LLCShawnee
- Arizona Isotopes Science Research Corp.Bunker Hill
- Arkema, Inc.Piffard
- Arkema, Inc.Memphis
- Astellas Gene Therapies, Inc.Sanford
- AstraZeneca Pharmaceuticals LPCoppell
- AstraZeneca Pharmaceuticals LPFrederick
- AstraZeneca Pharmaceuticals LPRedwood City
- Atlant Global, LLCKennesaw
- Aurorium LLCMidlothian
- Aurorium LLCZeeland
- AVA, Inc.Willowbrook
- Avanti Polar LipidsAlabaster
- Avantor Performance Materials, LLCPhillipsburg
- Avid Bioservices Inc.Tustin
- Avista Pharma Solutions, Inc. dba CambrexLongmont
- Avodah Naturals LLCAmerican Fork
- B. L. Mitchell, Inc.LELAND
- Bachem Americas, Inc.Vista
- Bachem Americas, Inc.Torrance
- Bajaj Medical, LLCChicago
- Bakelite Chemicals LLCAlbany
- Barr Laboratories LLCForest
- BASF CorporationEast Setauket
- BASF CorporationBishop
- BASF CorporationGeismar
- Baxalta US Inc.Van Nuys
- BAXALTA US INC.THOUSAND OAKS
- Baxter Healthcare CorporationGuayama
- Baxter Healthcare CorporationMarion
- Benuvia Operations, LLCRound Rock
- Best Sanitizers, IncWalton
- Bimeda, Inc.Le Sueur
- BioChem Sioux City Inc.Sioux City
- Biocogent LLCStony Brook
- Biogen MA Inc.Morrisville
- BioMarin Pharmaceutical Inc.Novato
- BioMimetic Therapeutics, LLCFranklin
- BioSpectra Inc.Stroudsburg
- BioSpectra Inc.Bangor
- BioZen Therapeutics Inc.Monroe Township
- BLA Enterprises, LLCLakewood
- Boehringer Ingelheim Fremont, Inc.Fremont
Showing 120 of 513, GMP-matched sites first; the full list is linked below.
Other sites with EU/UK GMP documents (80)
- AbbVie Inc.North ChicagoGMP match
- Advanced Therapies, LLCPhiladelphiaGMP match
- Afton Scientific, LLCCharlottesville
- Alcami Carolinas CorporationWilmington
- Alexion Pharmaceuticals Inc.Bogart
- Alkermes, IncWilmington
- Amgen Inc.Louisville
- Anesta LLCSalt Lake City
- Associates of Cape Cod, Inc.East FalmouthGMP match
- AstraZeneca Pharmaceuticals LPNewark
- AstraZeneca Pharmaceuticals LPPhiladelphiaGMP match
- Baxalta US Inc.Social CircleGMP match
- BAXALTA US INC.ROUND LAKEGMP match
- BioAgilytix Labs, LLCDurham
- Bioreliance CorporationRockvilleGMP match
- Catalent Maryland, Inc.BaltimoreGMP match
- Catalent Micron Technologies, Inc.Malvern
- Catalent Pharma Solutions, LLCWinchester
- Catalent Pharma Solutions, LLCPhiladelphia
- Charles River Laboratories, Inc.MalvernGMP match
- Charles River Laboratories, Inc.WayneGMP match
- Charles River Laboratories, Inc.WilmingtonGMP match
- Corixa CorporationMarietta
- CSL Behring L.L.C.BradleyGMP match
- DPT Laboratories, Ltd.San Antonio
- DPT Laboratories, Ltd.San Antonio
- DPT Laboratories, Ltd.San Antonio
- E-BEAM Services, Inc.Cranbury
- E-BEAM Services, Inc.Lebanon
- Eurofins Lancaster Laboratories, LLCLancaster
- Evonik CorporationBirmingham
- Fareva Richmond, Inc.Henrico
- Ferndale Laboratories, Inc.Ferndale
- Fisher BioServices Inc.FrederickGMP match
- Fresenius Kabi USA, LLCMelrose Park
- Fresenius Kabi USA, LLCGrand Island
- Gateway Analytical, LLC>GibsoniaGMP match
- GI Accelerate Memphis LLCMemphisGMP match
- Grand River Aseptic Manufacturing IncGrand RapidsGMP match
- Grifols Biologicals LLCLos Angeles
Only sites registered with the US FDA appear, so manufacturing that serves only other markets is missing and these figures understate national capacity. A GMP match requires the certificate address to name the site's street and its city or postcode; an unmatched site is not an uncertified site.