Contract manufacturer & testing lab regulatory records

The public regulatory record of contract manufacturers and testing labs, site by site. 175 sites. Every entry links to the regulator's own publication. Capabilities are quoted from each company's website.

This is a record of what regulators published, not a rating. There are no scores or grades here.

Records attached: 1,178 FDA inspections · 185 inspections with posted 483 citations · 9 warning letters · 2 recalls. Data refreshed 16 Oct 2026.

Aenova — Latina
Latina, Italy · CDMO · FEI 3007687501

Sterile fill-finishSmall moleculeAPI / drug substance (chemical)Oral solid doseClinical trial supply & packagingAnalytical testingMicrobiology

2 records in last 3 years; latest: FDA inspection, 11 Apr 2025
Aenova — Munster
Munster, Germany · CDMO · FEI 3006010798

API / drug substance (chemical)Highly potent (HPAPI)Oral solid doseInhalation & nasalClinical trial supply & packagingAnalytical testingControlled substances

1 record in last 3 years; latest: FDA inspection, 20 Nov 2024
Aenova — Ratisbon
Ratisbon, Germany · CDMO · FEI 3008293991

Sterile fill-finishHighly potent (HPAPI)Oral solid doseOral liquids & semi-solidsClinical trial supply & packagingFormulation & process development

1 record in last 3 years; latest: FDA inspection, 26 Jul 2024
Afton Scientific — Charlottesville
Charlottesville, Virginia, United States · CDMO · FEI 1000123236

Sterile fill-finishSmall moleculeAnalytical testing

2 records in last 3 years; latest: FDA inspection, 08 May 2024
AGC Biologics — Bothell
Bothell, Washington, United States · CDMO · FEI 3000209996

LyophilizationBiologics drug substanceADCs & bioconjugatesAnalytical testingFormulation & process development

2 records in last 3 years; latest: FDA inspection, 29 May 2026
AGC Biologics — Soborg
Soborg, Denmark · CDMO · FEI 3004708748

Biologics drug substanceFormulation & process development

No matched records in last 3 years
Alcami — Charleston
Charleston, South Carolina, United States · CDMO · FEI 1000110990

Sterile fill-finish

6 records in last 3 years; latest: Form 483 observations, 22 Apr 2026
Aldevron — Prairie Rose
Prairie Rose, North Dakota, United States · CDMO · FEI 3015047170

Sterile fill-finishCell & gene therapymRNA & lipid nanoparticles

1 record in last 3 years; latest: FDA inspection, 08 Nov 2024
Almac — Craigavon
Craigavon, United Kingdom · CDMO · FEI 3008699637

Small moleculeAPI / drug substance (chemical)Highly potent (HPAPI)Peptides & oligonucleotides

1 record in last 3 years; latest: FDA inspection, 08 May 2025
Bachem — Bubendorf
Bubendorf, Switzerland · CDMO · FEI 1000153019

Peptides & oligonucleotidesFormulation & process development

1 record in last 3 years; latest: FDA inspection, 16 Aug 2024
Bachem — Torrance
Torrance, California, United States · CDMO · FEI 2024023

API / drug substance (chemical)Peptides & oligonucleotidesFormulation & process development

3 records in last 3 years; latest: FDA inspection, 04 May 2026
Bachem — Vionnaz
Vionnaz, Switzerland · CDMO · FEI 3002808225

Small moleculeAPI / drug substance (chemical)Peptides & oligonucleotidesAnalytical testing

No matched records in last 3 years
Bachem — Vista
Vista, California, United States · CDMO · FEI 3000718309

API / drug substance (chemical)Peptides & oligonucleotidesFormulation & process development

1 record in last 3 years; latest: FDA inspection, 20 May 2026
Bend Bioscience (formerly Societal CDMO) — Gainesville
Gainesville, Georgia, United States · CDMO · FEI 1035761

Oral solid dose

2 records in last 3 years; latest: FDA inspection, 19 Nov 2024
BioVectra — Charlottetown
Charlottetown, Canada · CDMO · FEI 3004063541

Biologics drug substance

1 record in last 3 years; latest: FDA inspection, 19 Apr 2024
Bora Pharmaceuticals — Baltimore
Baltimore, Maryland, United States · CDMO · FEI 1000512361

Sterile fill-finishLyophilizationSmall moleculeClinical trial supply & packagingAnalytical testing

1 record in last 3 years; latest: FDA inspection, 25 Jul 2024
Bora Pharmaceuticals — Maple Grove
Maple Grove, Minnesota, United States · CDMO · FEI 3004106442

Oral solid doseClinical trial supply & packagingAnalytical testing

No matched records in last 3 years
Bora Pharmaceuticals — Mississauga
Mississauga, Canada · CDMO · FEI 3002807086

Oral solid doseOral liquids & semi-solidsInhalation & nasalClinical trial supply & packaging

2 records in last 3 years; latest: Form 483 observations, 28 Jan 2025
Bora Pharmaceuticals — Tao Yuan Shi
Tao Yuan Shi, Taiwan · CDMO · FEI 3005674517

Oral solid doseOral liquids & semi-solids

No matched records in last 3 years
Boston Analytical — Salem
Salem, New Hampshire, United States · Testing lab · FEI 1221426

Analytical testingMedical device testing

No matched records in last 3 years
Cambrex — Charles City
Charles City, Iowa, United States · CDMO · FEI 1000119390

API / drug substance (chemical)Highly potent (HPAPI)Analytical testingFormulation & process developmentControlled substances

1 record in last 3 years; latest: FDA inspection, 07 Mar 2025
Cambrex — Karlskoga
Karlskoga, Sweden · CDMO · FEI 3001686607

Small moleculeAPI / drug substance (chemical)Analytical testing

1 record in last 3 years; latest: FDA inspection, 24 May 2024
Cambrex — Paullo
Paullo, Italy · CDMO · FEI 3003723076

API / drug substance (chemical)Analytical testing

No matched records in last 3 years
CARBOGEN AMCIS — Aarau
Aarau, Switzerland · CDMO · FEI 3005976586

API / drug substance (chemical)Solid-state & particle characterization

1 record in last 3 years; latest: FDA inspection, 26 Jun 2024
CARBOGEN AMCIS — Bubendorf
Bubendorf, Switzerland · CDMO · FEI 3000998501

API / drug substance (chemical)Highly potent (HPAPI)ADCs & bioconjugatesFormulation & process development

1 record in last 3 years; latest: FDA inspection, 14 Nov 2025
Catalent — Baltimore
Baltimore, Maryland, United States · CDMO · FEI 3015558590

Cell & gene therapyAnalytical testingFormulation & process development

2 records in last 3 years; latest: FDA inspection, 09 Apr 2025
Catalent — Beinheim
Beinheim, France · CDMO · FEI 3002808036

Small moleculeHighly potent (HPAPI)Oral solid doseSoftgelsClinical trial supply & packagingAnalytical testingControlled substances

No matched records in last 3 years
Catalent — Buenos Aires
Buenos Aires, Argentina · CDMO · FEI 3004258511

Small moleculeSoftgelsClinical trial supply & packagingAnalytical testing

1 record in last 3 years; latest: FDA inspection, 09 Nov 2023
Catalent — Dartford
Dartford, United Kingdom · CDMO · FEI 3002807652

Small moleculeHighly potent (HPAPI)Oral solid doseSpray drying & particle engineeringAnalytical testingSolid-state & particle characterization

No matched records in last 3 years
Catalent — Eberbach
Eberbach, Germany · CDMO · FEI 3002808098

Small moleculeHighly potent (HPAPI)SoftgelsClinical trial supply & packagingAnalytical testingFormulation & process development

1 record in last 3 years; latest: FDA inspection, 02 Feb 2024
Catalent — Greenville
Greenville, North Carolina, United States · CDMO · FEI 3000209735

Small moleculeOral solid doseClinical trial supply & packagingAnalytical testingFormulation & process development

3 records in last 3 years; latest: FDA inspection, 24 Oct 2025
Catalent — Harmans
Harmans, Maryland, United States · CDMO · FEI 3015434301

Sterile fill-finishBiologics drug substanceCell & gene therapyClinical trial supply & packagingAnalytical testingFormulation & process development

1 record in last 3 years; latest: FDA inspection, 15 Nov 2024
Catalent — Kansas City
Kansas City, Missouri, United States · CDMO · FEI 3002929455

Highly potent (HPAPI)Clinical trial supply & packaging

No matched records in last 3 years
Catalent — Malvern
Malvern, Pennsylvania, United States · CDMO · FEI 3007992266

Small moleculeAPI / drug substance (chemical)Highly potent (HPAPI)Oral solid doseSpray drying & particle engineeringAnalytical testingSolid-state & particle characterization

1 record in last 3 years; latest: FDA inspection, 09 Jun 2025
Catalent — Morrisville
Morrisville, North Carolina, United States · CDMO · FEI 1000110912

Small moleculeInhalation & nasalSpray drying & particle engineeringAnalytical testingFormulation & process development

4 records in last 3 years; latest: Form 483 observations, 22 May 2026
Catalent — Philadelphia
Philadelphia, Pennsylvania, United States · CDMO · FEI 3007617094

Clinical trial supply & packaging

2 records in last 3 years; latest: FDA inspection, 17 Dec 2025
Catalent — Saint Petersburg
Saint Petersburg, Florida, United States · CDMO · FEI 1811396

Small moleculeOral solid doseSoftgelsClinical trial supply & packagingAnalytical testing

3 records in last 3 years; latest: FDA inspection, 30 Jan 2026
Catalent — Schorndorf
Schorndorf, Germany · CDMO · FEI 3003831171

Small moleculeOral solid doseClinical trial supply & packagingFormulation & process development

No matched records in last 3 years
Catalent — Strathroy
Strathroy, Canada · CDMO · FEI 3007325436

Small moleculeSoftgelsClinical trial supply & packagingAnalytical testingFormulation & process development

2 records in last 3 years; latest: FDA inspection, 02 May 2025
Catalent — Swindon
Swindon, United Kingdom · CDMO · FEI 3003812585

LyophilizationSmall moleculeOral solid dosePeptides & oligonucleotidesClinical trial supply & packagingFormulation & process developmentControlled substances

1 record in last 3 years; latest: FDA inspection, 10 Oct 2024
Catalent — Winchester
Winchester, Kentucky, United States · CDMO · FEI 1000122400

Small moleculeOral solid doseClinical trial supply & packaging

2 records in last 3 years; latest: Form 483 observations, 22 Apr 2025
Catalent — Windsor
Windsor, Canada · CDMO · FEI 3000118564

Small moleculeHighly potent (HPAPI)SoftgelsClinical trial supply & packagingAnalytical testingMicrobiology

No matched records in last 3 years
CordenPharma — Caponago
Caponago, Italy · CDMO · FEI 3002880938

mRNA & lipid nanoparticles

1 record in last 3 years; latest: FDA inspection, 28 Mar 2025
CordenPharma — Chenove
Chenove, France · CDMO · FEI 3002808295

API / drug substance (chemical)

1 record in last 3 years; latest: FDA inspection, 14 Feb 2025
CordenPharma — Liestal
Liestal, Switzerland · CDMO · FEI 3002561809

API / drug substance (chemical)

1 record in last 3 years; latest: FDA inspection, 14 Jun 2024
CordenPharma — Treviglio
Treviglio, Italy · CDMO · FEI 3002806963

API / drug substance (chemical)

2 records in last 3 years; latest: FDA inspection, 26 Jun 2024
CordenPharma — Villars-Sur-Glane
Villars-Sur-Glane, Switzerland · CDMO · FEI 3009018997

mRNA & lipid nanoparticles

1 record in last 3 years; latest: FDA inspection, 26 Jun 2025
Curia — Albuquerque
Albuquerque, New Mexico, United States · CDMO · FEI 1643045

Sterile fill-finishLyophilizationBiologics drug substanceSmall moleculePeptides & oligonucleotidesADCs & bioconjugatesClinical trial supply & packagingMicrobiologyControlled substances

1 record in last 3 years; latest: FDA inspection, 28 Jun 2024
Curia — Aurangabad
Aurangabad, India · CDMO · FEI 3008580576

API / drug substance (chemical)Spray drying & particle engineeringSolid-state & particle characterization

2 records in last 3 years; latest: FDA inspection, 21 Jul 2026
Curia — Boecillo
Boecillo, Spain · CDMO · FEI 3002996872

Sterile fill-finishAPI / drug substance (chemical)Highly potent (HPAPI)Spray drying & particle engineeringAnalytical testingMicrobiologySolid-state & particle characterization

No matched records in last 3 years
Curia — Bon Encontre
Bon Encontre, France · CDMO · FEI 3009615607

API / drug substance (chemical)Formulation & process developmentControlled substances

1 record in last 3 years; latest: FDA inspection, 27 Nov 2025
Curia — Origgio
Origgio, Italy · CDMO · FEI 1000330416

API / drug substance (chemical)

No matched records in last 3 years
Curia — Rensselaer
Rensselaer, New York, United States · CDMO · FEI 1310298

API / drug substance (chemical)Highly potent (HPAPI)Analytical testingControlled substances

3 records in last 3 years; latest: Warning letter, 18 Sep 2026
Curia — Rozzano
Rozzano, Italy · CDMO · FEI 3002807919

API / drug substance (chemical)

No matched records in last 3 years
Curia — Springfield
Springfield, Missouri, United States · CDMO · FEI 1941037

API / drug substance (chemical)Controlled substances

1 record in last 3 years; latest: FDA inspection, 02 Dec 2025
Curia — Tonneins
Tonneins, France · CDMO · FEI 3006257961

API / drug substance (chemical)

1 record in last 3 years; latest: FDA inspection, 28 Mar 2025
Delpharm — Boucherville
Boucherville, Canada · CDMO · FEI 3000280957

Oral liquids & semi-solids

2 records in last 3 years; latest: FDA inspection, 26 Jan 2024
Delpharm — Huningue
Huningue, France · CDMO · FEI 3003157245

Oral liquids & semi-solids

1 record in last 3 years; latest: FDA inspection, 30 Nov 2023
Delpharm — Meppel
Meppel, Netherlands · CDMO · FEI 3002808518

Sterile fill-finishClinical trial supply & packaging

1 record in last 3 years; latest: FDA inspection, 31 Oct 2024
Delpharm — Segrate
Segrate, Italy · CDMO · FEI 3003716872

Sterile fill-finishClinical trial supply & packaging

No matched records in last 3 years
EUROAPI — Brindisi
Brindisi, Italy · CDMO · FEI 3003677892

API / drug substance (chemical)

No matched records in last 3 years
EUROAPI — Budapest
Budapest, Hungary · CDMO · FEI 3002806675

API / drug substance (chemical)Highly potent (HPAPI)

No matched records in last 3 years
EUROAPI — Frankfurt Am Main
Frankfurt Am Main, Germany · CDMO · FEI 3020754015

LyophilizationAPI / drug substance (chemical)Peptides & oligonucleotidesSpray drying & particle engineering

No matched records in last 3 years
EUROAPI — Vertolaye
Vertolaye, France · CDMO · FEI 1463

API / drug substance (chemical)Highly potent (HPAPI)Spray drying & particle engineering

1 record in last 3 years; latest: FDA inspection, 08 Mar 2024
Eurofins BioPharma Product Testing — Cary
Cary, North Carolina, United States · Testing lab · FEI 3009827154

Analytical testingMicrobiologyMedical device testing

1 record in last 3 years; latest: FDA inspection, 01 Aug 2025
Eurofins BioPharma Product Testing — Dungarvan
Dungarvan, Ireland · Testing lab · FEI 3002807550

Analytical testingMicrobiology

1 record in last 3 years; latest: FDA inspection, 20 Jun 2025
Eurofins BioPharma Product Testing — Esplugues De Llobregat
Esplugues De Llobregat, Spain · Testing lab · FEI 3007914833

Microbiology

1 record in last 3 years; latest: FDA inspection, 19 Jun 2025
Eurofins BioPharma Product Testing — Glostrup
Glostrup, Denmark · Testing lab · FEI 3006272083

Analytical testingMicrobiology

No matched records in last 3 years
Eurofins BioPharma Product Testing — Lancaster
Lancaster, Pennsylvania, United States · Testing lab · FEI 2513291

Analytical testingMicrobiology

3 records in last 3 years; latest: FDA inspection, 23 Sep 2025
Eurofins BioPharma Product Testing — Les Ulis
Les Ulis, France · Testing lab · FEI 3010164760

Solid-state & particle characterization

No matched records in last 3 years
Eurofins BioPharma Product Testing — North York
North York, Canada · Testing lab · FEI 3002996761

Analytical testingMicrobiology

1 record in last 3 years; latest: FDA inspection, 15 Nov 2023
Eurofins BioPharma Product Testing — Planegg
Planegg, Germany · Testing lab · FEI 3003706029

Analytical testingMicrobiology

No matched records in last 3 years
Eurofins BioPharma Product Testing — Portage
Portage, Michigan, United States · Testing lab · FEI 1833335

Analytical testingMicrobiology

2 records in last 3 years; latest: FDA inspection, 30 May 2025
Eurofins BioPharma Product Testing — Vimodrone
Vimodrone, Italy · Testing lab · FEI 3002806530

Analytical testingMicrobiology

2 records in last 3 years; latest: FDA inspection, 13 Sep 2024
Frontage Laboratories — Exton
Exton, Pennsylvania, United States · Testing lab · FEI 3006799640

Bioanalytical

6 records in last 3 years; latest: FDA inspection, 18 Jun 2026
FUJIFILM Biotechnologies — Billingham
Billingham, United Kingdom · CDMO · FEI 3007182567

Formulation & process development

No matched records in last 3 years
FUJIFILM Biotechnologies — College Station
College Station, Texas, United States · CDMO · FEI 3011948449

Cell & gene therapy

No matched records in last 3 years
FUJIFILM Biotechnologies — Hillerod
Hillerod, Denmark · CDMO · FEI 3006339887

Biologics drug substance

No matched records in last 3 years
FUJIFILM Biotechnologies — Research Triangle Park
Research Triangle Park, North Carolina, United States · CDMO · FEI 3000718852

Biologics drug substanceAPI / drug substance (chemical)Microbiology

No matched records in last 3 years
Gland Pharma — Hyderabad
Hyderabad, India · CDMO · FEI 3002647489

Sterile fill-finishLyophilizationOphthalmics

2 records in last 3 years; latest: FDA inspection, 25 Jul 2024
Gland Pharma — Visakhapatnam
Visakhapatnam, India · CDMO · FEI 3009056604

LyophilizationAPI / drug substance (chemical)

No matched records in last 3 years
Grand River Aseptic Manufacturing — Grand Rapids
Grand Rapids, Michigan, United States · CDMO · FEI 3008716173

Sterile fill-finishLyophilizationSmall molecule

3 records in last 3 years; latest: FDA inspection, 04 Nov 2025
Hovione — East Windsor
East Windsor, New Jersey, United States · CDMO · FEI 3006106736

API / drug substance (chemical)Highly potent (HPAPI)Inhalation & nasal

1 record in last 3 years; latest: FDA inspection, 11 Jun 2025
Hovione — Loures
Loures, Portugal · CDMO · FEI 3002807208

API / drug substance (chemical)Highly potent (HPAPI)Inhalation & nasal

1 record in last 3 years; latest: FDA inspection, 24 Oct 2024
Hovione — Ringaskiddy
Ringaskiddy, Ireland · CDMO · FEI 3008058822

API / drug substance (chemical)Highly potent (HPAPI)Inhalation & nasal

No matched records in last 3 years
Hovione — Taipa
Taipa, Macao · CDMO · FEI 3002807210

API / drug substance (chemical)Highly potent (HPAPI)Inhalation & nasal

1 record in last 3 years; latest: FDA inspection, 12 Dec 2025
Intertek — Royston
Royston, United Kingdom · Testing lab · FEI 3002807539

Analytical testing

No matched records in last 3 years
KBI Biopharma — Boulder
Boulder, Colorado, United States · CDMO · FEI 3011326133

Analytical testingSolid-state & particle characterization

No matched records in last 3 years
KBI Biopharma — Durham
Durham, North Carolina, United States · CDMO · FEI 3004638264

Biologics drug substance

1 record in last 3 years; latest: FDA inspection, 01 Apr 2026
Kindeva Drug Delivery — Loughborough
Loughborough, United Kingdom · CDMO · FEI 3002807586

Inhalation & nasalClinical trial supply & packagingAnalytical testingMicrobiology

1 record in last 3 years; latest: FDA inspection, 14 Mar 2025
Kindeva Drug Delivery — Northridge
Northridge, California, United States · CDMO · FEI 2010441

Inhalation & nasalClinical trial supply & packaging

2 records in last 3 years; latest: Form 483 observations, 13 Nov 2025
Lifecore Biomedical — Chaska
Chaska, Minnesota, United States · CDMO · FEI 1000115753

Clinical trial supply & packagingAnalytical testingMicrobiology

2 records in last 3 years; latest: FDA inspection, 12 Mar 2025
Lonza — Bend
Bend, Oregon, United States · CDMO · FEI 3003722743, 1000656789

Small moleculeAPI / drug substance (chemical)Oral solid doseInhalation & nasalSpray drying & particle engineeringAnalytical testingFormulation & process development

4 records in last 3 years; latest: FDA inspection, 19 May 2026
Lonza — Houston
Houston, Texas, United States · CDMO · FEI 3013629214

Biologics drug substanceCell & gene therapyFormulation & process development

No matched records in last 3 years
Lonza — O Porrino
O Porrino, Spain · CDMO · FEI 3006067169

Biologics drug substanceFormulation & process development

1 record in last 3 years; latest: FDA inspection, 07 Apr 2025
Lonza — Portsmouth
Portsmouth, New Hampshire, United States · CDMO · FEI 3001451441

Biologics drug substanceCell & gene therapyMicrobiologyFormulation & process development

2 records in last 3 years; latest: FDA inspection, 06 Feb 2026
Lonza — Slough
Slough, United Kingdom · CDMO · FEI 1000583959

Biologics drug substanceFormulation & process development

No matched records in last 3 years
Lonza — Tampa
Tampa, Florida, United States · CDMO · FEI 3001549109

Oral solid dose

2 records in last 3 years; latest: FDA inspection, 22 Aug 2025
Lonza — Visp
Visp, Switzerland · CDMO · FEI 3002930340

Biologics drug substanceSmall moleculeAPI / drug substance (chemical)Highly potent (HPAPI)Peptides & oligonucleotidesADCs & bioconjugatesCell & gene therapyClinical trial supply & packagingAnalytical testing

No matched records in last 3 years
Minaris — Allendale
Allendale, New Jersey, United States · CDMO · FEI 3003407523

Cell & gene therapyMicrobiologyFormulation & process development

2 records in last 3 years; latest: FDA inspection, 29 Sep 2025
Nelson Labs — Itasca
Itasca, Illinois, United States · Testing lab · FEI 3000717698

Analytical testingMicrobiologyExtractables & leachablesMedical device testing

2 records in last 3 years; latest: FDA inspection, 26 Sep 2025
Nelson Labs — Leuven
Leuven, Belgium · Testing lab · FEI 3005742674

Extractables & leachablesMedical device testing

1 record in last 3 years; latest: FDA inspection, 30 Apr 2024
Nelson Labs — Salt Lake City
Salt Lake City, Utah, United States · Testing lab · FEI 3000233845

Analytical testingMicrobiologyExtractables & leachables

2 records in last 3 years; latest: FDA inspection, 30 Jul 2025
Olon — Capua
Capua, Italy · CDMO · FEI 3002807048

Spray drying & particle engineering

1 record in last 3 years; latest: FDA inspection, 24 May 2024
Olon — Casaletto Lodigiano
Casaletto Lodigiano, Italy · CDMO · FEI 3002808159

API / drug substance (chemical)Spray drying & particle engineering

1 record in last 3 years; latest: FDA inspection, 16 Jan 2026
Olon — Concord Township
Concord Township, Ohio, United States · CDMO · FEI 3013648152

API / drug substance (chemical)Analytical testingFormulation & process development

1 record in last 3 years; latest: FDA inspection, 10 Oct 2025
Olon — Dorno
Dorno, Italy · CDMO · FEI 3009407861

Spray drying & particle engineering

No matched records in last 3 years
Olon — Garbagnate Milanese
Garbagnate Milanese, Italy · CDMO · FEI 3002807440

Spray drying & particle engineeringControlled substances

No matched records in last 3 years
Olon — Mulazzano
Mulazzano, Italy · CDMO · FEI 3002808211

Highly potent (HPAPI)Spray drying & particle engineering

No matched records in last 3 years
Olon — Settimo Torinese
Settimo Torinese, Italy · CDMO · FEI 3002806373

LyophilizationBiologics drug substance

No matched records in last 3 years
Pace Life Sciences — Oakdale
Oakdale, Minnesota, United States · Testing lab · FEI 3001452367

Analytical testingMicrobiologyExtractables & leachables

3 records in last 3 years; latest: Form 483 observations, 29 May 2026
Pharmaceutics International (Pii) — Hunt Valley
Hunt Valley, Maryland, United States · CDMO · FEI 1000513101

Sterile fill-finishLyophilizationHighly potent (HPAPI)Oral solid doseSoftgelsClinical trial supply & packagingAnalytical testingFormulation & process development

2 records in last 3 years; latest: FDA inspection, 06 Dec 2024
Piramal Pharma Solutions — Aurora
Aurora, Canada · CDMO · FEI 3002808377

API / drug substance (chemical)Highly potent (HPAPI)Spray drying & particle engineeringAnalytical testingFormulation & process development

1 record in last 3 years; latest: FDA inspection, 30 May 2025
Piramal Pharma Solutions — Grangemouth
Grangemouth, United Kingdom · CDMO · FEI 3003723155

Sterile fill-finishSmall moleculeHighly potent (HPAPI)ADCs & bioconjugatesClinical trial supply & packagingAnalytical testingFormulation & process development

No matched records in last 3 years
Piramal Pharma Solutions — Lexington
Lexington, Kentucky, United States · CDMO · FEI 3006419237

Sterile fill-finishLyophilizationAPI / drug substance (chemical)Highly potent (HPAPI)ADCs & bioconjugatesAnalytical testingMicrobiologySolid-state & particle characterizationFormulation & process development

3 records in last 3 years; latest: Form 483 observations, 10 Dec 2025
Piramal Pharma Solutions — Morpeth
Morpeth, United Kingdom · CDMO · FEI 3002808116

API / drug substance (chemical)Oral solid doseClinical trial supply & packagingFormulation & process development

No matched records in last 3 years
Piramal Pharma Solutions — Pithampur
Pithampur, India · CDMO · FEI 3005259207

Oral solid doseClinical trial supply & packagingAnalytical testingMicrobiologyOphthalmics

No matched records in last 3 years
PolyPeptide — Braine-L'Alleud
Braine-L'Alleud, Belgium · CDMO · FEI 3002808410

Peptides & oligonucleotidesSpray drying & particle engineering

1 record in last 3 years; latest: FDA inspection, 18 Dec 2023
PolyPeptide — Strasbourg
Strasbourg, France · CDMO · FEI 3007417577

LyophilizationPeptides & oligonucleotides

1 record in last 3 years; latest: FDA inspection, 04 Jul 2024
PolyPeptide — Torrance
Torrance, California, United States · CDMO · FEI 1000519239

LyophilizationAPI / drug substance (chemical)Oral liquids & semi-solidsPeptides & oligonucleotidesFormulation & process development

1 record in last 3 years; latest: FDA inspection, 10 May 2024
PPD (Thermo Fisher Scientific) — Athlone
Athlone, Ireland · Testing lab · FEI 3008676264

Analytical testingExtractables & leachablesMedical device testingSolid-state & particle characterization

No matched records in last 3 years
PPD (Thermo Fisher Scientific) — Middleton
Middleton, Wisconsin, United States · Testing lab · FEI 2129896

Analytical testingMicrobiology

3 records in last 3 years; latest: FDA inspection, 01 May 2026
Quotient Sciences — Alnwick
Alnwick, United Kingdom · CDMO · FEI 3008798339

Clinical trial supply & packaging

1 record in last 3 years; latest: FDA inspection, 29 Aug 2024
Quotient Sciences — Boothwyn
Boothwyn, Pennsylvania, United States · CDMO · FEI 3003882011

Small moleculeAPI / drug substance (chemical)Highly potent (HPAPI)MicrobiologyFormulation & process development

2 records in last 3 years; latest: Form 483 observations, 17 Sep 2025
Recipharm — Bengaluru
Bengaluru, India · CDMO · FEI 3009150119

Oral solid doseOral liquids & semi-solidsClinical trial supply & packagingAnalytical testing

1 record in last 3 years; latest: FDA inspection, 22 Mar 2024
Recipharm — Leganes
Leganes, Spain · CDMO · FEI 3000298591

Highly potent (HPAPI)Oral solid doseClinical trial supply & packaging

1 record in last 3 years; latest: FDA inspection, 26 Oct 2023
Recipharm — Uppsala
Uppsala, Sweden · CDMO · FEI 1000171246

API / drug substance (chemical)Oral solid doseOral liquids & semi-solidsClinical trial supply & packaging

1 record in last 3 years; latest: FDA inspection, 17 Apr 2024
Rentschler Biopharma — Laupheim
Laupheim, Germany · CDMO · FEI 1000291122

Formulation & process development

No matched records in last 3 years
Rentschler Biopharma — Milford
Milford, Massachusetts, United States · CDMO · FEI 3003282293

Formulation & process development

1 record in last 3 years; latest: FDA inspection, 17 Jan 2025
Resilience — Mississauga
Mississauga, Canada · CDMO · FEI 3007503037

Biologics drug substanceHighly potent (HPAPI)Analytical testingMicrobiologyFormulation & process development

2 records in last 3 years; latest: Form 483 observations, 10 Nov 2023
Resilience — West Chester
West Chester, Ohio, United States · CDMO · FEI 3006316363

Sterile fill-finishClinical trial supply & packagingAnalytical testing

2 records in last 3 years; latest: Form 483 observations, 21 Jan 2025
Sharp Services — Allentown
Allentown, Pennsylvania, United States · CDMO · FEI 3004161147

Oral solid doseClinical trial supply & packaging

2 records in last 3 years; latest: FDA inspection, 22 Apr 2026
Sharp Services — Conshohocken
Conshohocken, Pennsylvania, United States · CDMO · FEI 2518332

Clinical trial supply & packaging

1 record in last 3 years; latest: FDA inspection, 06 Feb 2026
Sharp Services — Macungie
Macungie, Pennsylvania, United States · CDMO · FEI 3009566827

Sterile fill-finishOral solid doseClinical trial supply & packaging

2 records in last 3 years; latest: FDA inspection, 12 Sep 2025
Siegfried — Barbera Del Valles
Barbera Del Valles, Spain · CDMO · FEI 3002910506

Highly potent (HPAPI)Oral solid doseInhalation & nasalClinical trial supply & packaging

1 record in last 3 years; latest: Recall, 20 Nov 2023
Siegfried — El Masnou
El Masnou, Spain · CDMO · FEI 3002894596

Oral liquids & semi-solidsInhalation & nasalOphthalmics

No matched records in last 3 years
Siegfried — Evionnaz
Evionnaz, Switzerland · CDMO · FEI 3002807824

API / drug substance (chemical)Spray drying & particle engineeringAnalytical testing

No matched records in last 3 years
Siegfried — Grafton
Grafton, Wisconsin, United States · CDMO · FEI 3001655239

Highly potent (HPAPI)Formulation & process developmentControlled substances

1 record in last 3 years; latest: FDA inspection, 14 Aug 2024
Siegfried — Hameln
Hameln, Germany · CDMO · FEI 3002807877

Sterile fill-finish

1 record in last 3 years; latest: FDA inspection, 29 Aug 2024
Siegfried — Minden
Minden, Germany · CDMO · FEI 3002807400

Spray drying & particle engineering

No matched records in last 3 years
Siegfried — Nantong
Nantong, China · CDMO · FEI 3013046521

API / drug substance (chemical)

1 record in last 3 years; latest: FDA inspection, 05 Jul 2024
Siegfried — Pennsville
Pennsville, New Jersey, United States · CDMO · FEI 2227314

API / drug substance (chemical)Spray drying & particle engineeringControlled substances

1 record in last 3 years; latest: FDA inspection, 17 Sep 2025
Siegfried — Saint-Vulbas
Saint-Vulbas, France · CDMO · FEI 3002807787

API / drug substance (chemical)

No matched records in last 3 years
Siegfried — Zofingen
Zofingen, Switzerland · CDMO · FEI 3002808158

API / drug substance (chemical)Highly potent (HPAPI)Spray drying & particle engineering

1 record in last 3 years; latest: FDA inspection, 14 Feb 2025
Simtra BioPharma Solutions — Bloomington
Bloomington, Indiana, United States · CDMO · FEI 1000115571

Sterile fill-finishLyophilizationHighly potent (HPAPI)

1 record in last 3 years; latest: FDA inspection, 24 Sep 2024
Simtra BioPharma Solutions — Halle (Westf.)
Halle (Westf.), Germany · CDMO · FEI 3002806419

Sterile fill-finishLyophilizationHighly potent (HPAPI)

3 records in last 3 years; latest: Warning letter, 03 Mar 2026
Solvias — Canton
Canton, Massachusetts, United States · Testing lab · FEI 3001551778

Extractables & leachables

2 records in last 3 years; latest: FDA inspection, 16 Jul 2026
Solvias — Hombourg
Hombourg, France · Testing lab · FEI 3002806657

Analytical testingMicrobiologyBiosafety & viral testing

No matched records in last 3 years
Solvias — Kaiseraugst
Kaiseraugst, Switzerland · Testing lab · FEI 3008735083

Analytical testingMicrobiologyBiosafety & viral testingExtractables & leachablesMedical device testing

1 record in last 3 years; latest: FDA inspection, 07 Aug 2025
Sterling Pharma Solutions — Cramlington
Cramlington, United Kingdom · CDMO · FEI 3002806719

Small moleculeAPI / drug substance (chemical)Highly potent (HPAPI)Spray drying & particle engineeringAnalytical testingSolid-state & particle characterizationFormulation & process developmentControlled substances

1 record in last 3 years; latest: FDA inspection, 11 Jul 2025
Sterling Pharma Solutions — Ringaskiddy
Ringaskiddy, Ireland · CDMO · FEI 3002807776

LyophilizationSmall moleculeAPI / drug substance (chemical)Highly potent (HPAPI)Peptides & oligonucleotidesSpray drying & particle engineeringAnalytical testing

No matched records in last 3 years
Syngene — Bengaluru
Bengaluru, India · CDMO · FEI 3003600340

Sterile fill-finishBiologics drug substanceSmall moleculeADCs & bioconjugatesClinical trial supply & packaging

1 record in last 3 years; latest: FDA inspection, 20 Feb 2025
Tedor Pharma — Cumberland
Cumberland, Rhode Island, United States · CDMO · FEI 3003855180

Small moleculeAPI / drug substance (chemical)Clinical trial supply & packagingAnalytical testingFormulation & process developmentControlled substances

2 records in last 3 years; latest: Form 483 observations, 05 Jun 2025
Thermo Fisher Scientific (Patheon) — Bourgoin Jallieu Cedex
Bourgoin Jallieu Cedex, France · CDMO · FEI 3004468553

Small moleculeAPI / drug substance (chemical)Highly potent (HPAPI)Oral solid doseSpray drying & particle engineeringClinical trial supply & packagingFormulation & process development

No matched records in last 3 years
Thermo Fisher Scientific (Patheon) — Carrigaline
Carrigaline, Ireland · CDMO · FEI 1000170338

Small moleculeAPI / drug substance (chemical)Highly potent (HPAPI)Spray drying & particle engineeringClinical trial supply & packagingAnalytical testingSolid-state & particle characterizationFormulation & process development

No matched records in last 3 years
Thermo Fisher Scientific (Patheon) — Cincinnati
Cincinnati, Ohio, United States · CDMO · FEI 1510437

API / drug substance (chemical)Highly potent (HPAPI)Oral solid doseControlled substances

2 records in last 3 years; latest: FDA inspection, 26 Sep 2025
Thermo Fisher Scientific (Patheon) — Ferentino
Ferentino, Italy · CDMO · FEI 3004110157

Sterile fill-finishLyophilizationBiologics drug substanceSmall moleculeHighly potent (HPAPI)Peptides & oligonucleotidesClinical trial supply & packaging

1 record in last 3 years; latest: FDA inspection, 30 Jan 2026
Thermo Fisher Scientific (Patheon) — Florence
Florence, South Carolina, United States · CDMO · FEI 3000717636

Small moleculeAPI / drug substance (chemical)Highly potent (HPAPI)Spray drying & particle engineeringSolid-state & particle characterizationFormulation & process development

2 records in last 3 years; latest: FDA inspection, 12 Jun 2026
Thermo Fisher Scientific (Patheon) — Greenville
Greenville, North Carolina, United States · CDMO · FEI 1018495

Sterile fill-finishLyophilizationSmall moleculeAPI / drug substance (chemical)Clinical trial supply & packaging

4 records in last 3 years; latest: FDA inspection, 30 Jun 2026
Thermo Fisher Scientific (Patheon) — Groningen
Groningen, Netherlands · CDMO · FEI 3002608687

Biologics drug substancePeptides & oligonucleotidesAnalytical testingMicrobiology

1 record in last 3 years; latest: FDA inspection, 21 Aug 2024
Thermo Fisher Scientific (Patheon) — High Point
High Point, North Carolina, United States · CDMO · FEI 3001451366

API / drug substance (chemical)Highly potent (HPAPI)Oral solid doseSoftgelsAnalytical testingFormulation & process development

2 records in last 3 years; latest: Form 483 observations, 17 Jul 2025
Thermo Fisher Scientific (Patheon) — Linz
Linz, Austria · CDMO · FEI 3002806853

Small moleculeAPI / drug substance (chemical)Analytical testingSolid-state & particle characterizationFormulation & process development

1 record in last 3 years; latest: FDA inspection, 12 Sep 2024
Thermo Fisher Scientific (Patheon) — Manati
Manati, Puerto Rico, United States · CDMO · FEI 3003113148

Highly potent (HPAPI)Oral solid doseControlled substances

No matched records in last 3 years
Thermo Fisher Scientific (Patheon) — Mississauga
Mississauga, Canada · CDMO · FEI 3000264888

Highly potent (HPAPI)Oral solid doseFormulation & process development

No matched records in last 3 years
Thermo Fisher Scientific (Patheon) — Monza
Monza, Italy · CDMO · FEI 3003065803

Sterile fill-finishLyophilizationmRNA & lipid nanoparticlesClinical trial supply & packagingBioanalytical

2 records in last 3 years; latest: FDA inspection, 10 Feb 2026
Thermo Fisher Scientific (Patheon) — Ridgefield
Ridgefield, New Jersey, United States · CDMO · FEI 2246315

Sterile fill-finishClinical trial supply & packaging

4 records in last 3 years; latest: FDA inspection, 13 Jun 2024
Thermo Fisher Scientific (Patheon) — Saint Louis
Saint Louis, Missouri, United States · CDMO · FEI 3003418999

Biologics drug substanceFormulation & process development

2 records in last 3 years; latest: FDA inspection, 20 Nov 2024
Thermo Fisher Scientific (Patheon) — Swindon
Swindon, United Kingdom · CDMO · FEI 3002807216

Sterile fill-finishLyophilizationHighly potent (HPAPI)mRNA & lipid nanoparticlesClinical trial supply & packagingAnalytical testingFormulation & process development

1 record in last 3 years; latest: FDA inspection, 07 Jul 2026
Thermo Fisher Scientific (Patheon) — Tilburg
Tilburg, Netherlands · CDMO · FEI 1000384811

SoftgelsClinical trial supply & packagingAnalytical testingFormulation & process development

No matched records in last 3 years
Thermo Fisher Scientific (Patheon) — Whitby
Whitby, Canada · CDMO · FEI 3003516812

Oral solid doseClinical trial supply & packagingControlled substances

No matched records in last 3 years
Unither Pharmaceuticals — Coutances
Coutances, France · CDMO · FEI 3006974616

Analytical testingOphthalmics

No matched records in last 3 years
Unither Pharmaceuticals — Rochester
Rochester, New York, United States · CDMO · FEI 1314625

Sterile fill-finishOral liquids & semi-solidsInhalation & nasalAnalytical testingControlled substancesOphthalmics

2 records in last 3 years; latest: Form 483 observations, 15 May 2026
Vetter — Langenargen
Langenargen, Germany · CDMO · FEI 3002808846

Sterile fill-finishLyophilizationMicrobiology

1 record in last 3 years; latest: FDA inspection, 20 Mar 2024
Vetter — Ravensburg
Ravensburg, Germany · CDMO · FEI 3002270322

Sterile fill-finishMicrobiology

No matched records in last 3 years
Vetter — Ravensburg
Ravensburg, Germany · CDMO · FEI 3005987757

Sterile fill-finishLyophilizationMicrobiology

No matched records in last 3 years