Clinical Trials

Numerous clinical trials spanning Early Phase 1 through Phase 4 evaluate Mometasone furoate across inflammatory respiratory and dermatological conditions, including chronic sinusitis, allergic rhinitis, asthma, and atopic dermatitis. Featuring active, recruiting, completed, and withdrawn statuses, these studies are sponsored by pharmaceutical companies, medical device manufacturers, and academic institutions. Specific evaluations investigate local drug delivery systems and airway inflammatory markers to refine treatment regimens for inflammatory mucosal and skin diseases.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05348148 RECRUITING
Allergic Rhinitis; Vasomotor Rhinitis
Camillians Saint Mary's Hospital Luodong
 2020-06-16
NCT06914908 ENROLLING_BY_INVITATION
Chronic Rhinosinusitis With Nasal Polyps
Sanofi
 2025-05-12 PHASE2
NCT05776927 RECRUITING
Asthma
Novartis Pharmaceuticals
 2026-08-04 PHASE3
NCT05562466 RECRUITING
Asthma
Novartis Pharmaceuticals
 2023-05-11 PHASE3
NCT06399783 NOT_YET_RECRUITING
Alopecia Areata
Assiut University
 2024-10-01 PHASE4
NCT07787494 NOT_YET_RECRUITING
Chronic Rhinosinusitis (CRS)
Liaquat University of Medical & Health Sciences
 2026-09-07
NCT07800273 NOT_YET_RECRUITING
Chronic Rhinosinusitis
Liaquat University of Medical & Health Sciences
 2026-09-14
NCT07286201 ENROLLING_BY_INVITATION
Chronic Rhinosinusitis (CRS); Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps
Polyganics BV
 2026-03-19
NCT07532993 NOT_YET_RECRUITING
Allergic Rhinitis (AR)
Liaquat National Hospital & Medical College
 2026-09 PHASE4
NCT07784491 NOT_YET_RECRUITING
Allergic Rhinitis
Zhongshan Torch Development Zone People's Hospital
 2026-08-31
NCT06834360 ACTIVE_NOT_RECRUITING
Chronic Rhinosinusitis With Nasal Polyps
Sanofi
 2025-02-06 PHASE3
NCT06834347 ACTIVE_NOT_RECRUITING
Chronic Rhinosinusitis With Nasal Polyps
Sanofi
 2025-02-12 PHASE3
NCT07777796 COMPLETED
Chronic Cough (CC); Upper Airway Cough Syndrome; Chronic Rhinitis
Silesian University of Medicine
 2022-07-01
NCT06077019 RECRUITING
Exercise Performance
Morten Hostrup, PhD
 2023-10-03
NCT07525505 RECRUITING
Eczema/Atopic Dermatitis; Otitis Externa
Bezmialem Vakif University
 2026-01-12
NCT07721610 COMPLETED
Otits Media With Effusion
Isola Tiberina - Gemelli Isola Hospital, Rome, Italy
 2025-10-01 PHASE4
NCT06691113 COMPLETED
Chronic Rhinosinusitis Without Nasal Polyps
Sanofi
 2024-12-16 PHASE2
NCT07114107 NOT_YET_RECRUITING
Atopic Rhinitis; Atopic Asthma
Second Affiliated Hospital, Zhejiang University, School of Medicine
 2025-08
NCT06636240 RECRUITING
Atopic Dermatitis (Eczema); Atopic Dermatitis, Probiotics
Taipei Medical University Shuang Ho Hospital
 2025-03-17
NCT07593898 COMPLETED
Persistent Allergic Rhinitis
Dr. Behcet Uz Children's Hospital
 2025-01-02 PHASE4
NCT07311759 ACTIVE_NOT_RECRUITING
Chronic Paronychia
Cairo University
 2024-08-17 PHASE3
NCT06801353 NOT_YET_RECRUITING
Chronic Rhinosinusitis with Nasal Polyps (CRSwNP); Biological Therapy; Biomarkers
Beijing Tongren Hospital
 2025-02-01 PHASE4
NCT07016113 NOT_YET_RECRUITING
Vitiligo - Macular Depigmentation
Universitas Padjadjaran
 2025-07-01 PHASE2
NCT06013241 COMPLETED
Chronic Rhinosinusitis Without Nasal Polyps
Insmed Incorporated
 2023-10-30 PHASE2
NCT05505214 WITHDRAWN
Radiation Dermatitis
Montefiore Medical Center
 2023-09-01 PHASE2
NCT05382494 COMPLETED
Sleep Disorder; Breathing-Related; Snoring; Obstructive Sleep Apnea of Child; Sleep Disorders in Children; Tonsillar Hypertrophy; Adenoidal Disorder
Murdoch Childrens Research Institute
 2022-12-05 PHASE4
NCT06780644 NOT_YET_RECRUITING
Melasma
Indonesia University
 2025-02-17
NCT06642116 NOT_YET_RECRUITING
Rhinosinusitis Chronic; Wound Healing; Sinus Surgery; Mometasone Furoate
Polyganics BV
 2024-11
NCT04898764 COMPLETED
Rhinitis Medicamentosa
University Hospital, Ghent
 2020-10-21 PHASE4
NCT07016763 COMPLETED
Allergic Rhinitis
Isola Tiberina - Gemelli Isola Hospital, Rome, Italy
 2024-09-01 EARLY_PHASE1
NCT05390255 UNKNOWN
Sinusitis
Beijing Tongren Hospital
 2022-05-25 PHASE3
NCT04851964 COMPLETED
Chronic Rhinosinusitis With Nasal Polyps
AstraZeneca
 2021-04-22 PHASE3
NCT06200766 UNKNOWN
Seasonal Allergic Rhinitis
Zheng Liu ENT
 2023-08-25 PHASE3
NCT05038202 UNKNOWN
Allergic Rhinitis
Yingu Pharmaceutical Co., Ltd
 2021-06-16 PHASE4
NCT04596189 COMPLETED
Chronic Rhinosinusitis With Nasal Polyps
Centre hospitalier de l'Université de Montréal (CHUM)
 2021-05-25 PHASE4
NCT06126952 COMPLETED
Seasonal Allergic Rhinitis
MEDA Pharma GmbH & Co. KG
 2023-10-30 PHASE2
NCT05228483 UNKNOWN
Vulva Lichen Sclerosus
Xijing Hospital
 2021-11-23
NCT05887843 TERMINATED
Seasonal Allergic Rhinitis
Sandoz
 2023-06-08 PHASE1
NCT04271007 COMPLETED
Atopic Dermatitis
Libbs Farmacêutica LTDA
 2020-11-23 PHASE4
NCT04670653 WITHDRAWN
Allergic Rhinitis
EMS
 2022-08-01 PHASE3
NCT05311475 COMPLETED
Seasonal Allergic Rhinitis
Sandoz
 2022-04-04 PHASE3
NCT05017454 COMPLETED
Alopecia Areata
Kasr El Aini Hospital
 2021-05-01 EARLY_PHASE1
NCT04589663 COMPLETED
Asthma
Novartis Pharmaceuticals
 2021-06-07 PHASE2
NCT04615962 UNKNOWN
Atopic Dermatitis
Seanergy Dermatology Ltd.
 2021-01-01 PHASE1
NCT04499235 TERMINATED
Pemphigoid, Bullous
Alkahest, Inc.
 2020-01-30 PHASE2
NCT02110654 COMPLETED
Sinusitis; Nasal Polyps; Asthma
First Affiliated Hospital, Sun Yat-Sen University
 2014-06 PHASE4
NCT04484493 COMPLETED
Covid19; Anosmia
Benha University
 2020-08-08 PHASE3
NCT03614923 COMPLETED
Chronic Rhinosinusitis
AnaptysBio, Inc.
 2018-11-29 PHASE2
NCT03401229 COMPLETED
Nasal Polyposis
AstraZeneca
 2018-01-15 PHASE3
NCT02588326 COMPLETED
Hypersensitivity
University of Florida
 2018-09-21 PHASE1
NCT03705793 COMPLETED
Chronic Rhinosinusitis (Diagnosis); Allergic Rhinosinusitis; Chronic Eosinophilic Rhinosinusitis
Washington University School of Medicine
 2019-01-01 PHASE4
NCT03085797 COMPLETED
Nasal Polyps
GlaxoSmithKline
 2017-05-25 PHASE3
NCT03451318 UNKNOWN
Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) and Malocclusion
Shanghai Stomotological Hospital
 2018-03-02
NCT03491098 UNKNOWN
Otitis Media With Effusion
Muteea Mubark Salmen Bakuwiri
 2018-05-15 EARLY_PHASE1
NCT04532736 COMPLETED
Nasal Polyposis
Dokuz Eylul University
 2017-09-02 PHASE2
NCT02554786 COMPLETED
Asthma
Novartis Pharmaceuticals
 2015-12-29 PHASE3
NCT02478398 COMPLETED
Rhinitis, Allergic, Seasonal
Merck Sharp & Dohme LLC
 2015-07-20 PHASE3
NCT02113267 TERMINATED
Eosinophilic Esophagitis
Mogens Bove
 2014-04 PHASE2
NCT02898454 COMPLETED
Chronic Rhinosinusitis Phenotype With Nasal Polyps (CRSwNP)
Sanofi
 2016-11-28 PHASE3
NCT02912468 COMPLETED
Chronic Rhinosinusitis Phenotype With Nasal Polyps (CRSwNP)
Sanofi
 2016-12-05 PHASE3
NCT02573233 COMPLETED
Asthma
Sanofi
 2016-01-27 PHASE2
NCT02967731 COMPLETED
Chronic Sinusitis
Lyra Therapeutics
 2017-06-06 PHASE1
NCT02741271 COMPLETED
Asthma
Organon and Co
 2016-05-11 PHASE3
NCT02061202 COMPLETED
Sickle Cell Disease
Jeffrey Glassberg
 2014-03 PHASE2
NCT02967731 Completed
Chronic Sinusitis
Lyra Therapeutics
 2017-06-06 Phase 1
NCT02870205 COMPLETED
Seasonal Allergic Rhinitis (SAR)
Glenmark Specialty S.A.
 2016-08 PHASE3
NCT01616160 TERMINATED
Nasal Polyps
Massachusetts General Hospital
 2013-07 PHASE4
NCT01856543 COMPLETED
Invasive Breast Cancer
Memorial Sloan Kettering Cancer Center
 2013-05 PHASE3
NCT02495064 UNKNOWN
Early Radiation Dermatitis
Yao Liao
 2015-01 PHASE4
NCT01471340 COMPLETED
Asthma
Organon and Co
 2012-01-09 PHASE4
NCT02291549 COMPLETED
Chronic Sinusitis; Nasal Polyposis
Intersect ENT
 2014-12 PHASE3
NCT02631551 COMPLETED
Seasonal Allergic Rhinitis
Glenmark Specialty S.A.
 2016-03 PHASE3
NCT02498509 COMPLETED
Rhinitis, Allergic, Perennial
Chong Kun Dang Pharmaceutical
 2015-05 PHASE3
NCT01353599 UNKNOWN
Spinal Cord Injury
James J. Peters Veterans Affairs Medical Center
 2011-08 PHASE1
NCT02557269 UNKNOWN
Seasonal Allergic Rhinitis
Association Asthma, Bulgaria
 2015-05 PHASE4
NCT01082393 COMPLETED
Vitiligo
University Hospital, Ghent
 2010-02-16 PHASE4
NCT01671852 WITHDRAWN
Obstructive Sleep Apnea (Mild, Moderate, Severe) as Per Polysomnography
Children's & Women's Health Centre of British Columbia
 2012-05 PHASE3
NCT02397915 COMPLETED
Rhinitis, Allergic, Perennial and Seasonal
GlaxoSmithKline
 2015-03-26 PHASE4
NCT01700192 COMPLETED
Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Nonseasonal
ALK-Abelló A/S
 2013-01 PHASE3
NCT02318303 COMPLETED
Seasonal Allergic Rhinitis
Glenmark Pharmaceuticals Ltd. India
 2014-12 PHASE2
NCT02559440 COMPLETED
Adenoidal Hypertrophy
Guangzhou Women and Children's Medical Center
 2014-02 PHASE4
NCT01502371 COMPLETED
Asthma
Organon and Co
 2012-01-25 PHASE2
NCT01920893 COMPLETED
Nasal Polyps
Sanofi
 2013-08 PHASE2
NCT00967967 SUSPENDED
Asthma; Rhinitis
Laval University
 2009-03
NCT01118312 COMPLETED
Asthma; Rhinitis; Sinusitis
JHSPH Center for Clinical Trials
 2010-09 PHASE4
NCT02125253 COMPLETED
Seasonal Allergic Rhinitis
Amneal Pharmaceuticals, LLC
 2014-01 PHASE3
NCT03444506 COMPLETED
Seasonal Allergic Rhinitis
Glenmark Pharmaceuticals Ltd. India
 2014-01-27 PHASE2
NCT01026870 WITHDRAWN
Asthma
Organon and Co
 2012-06 PHASE3
NCT01732536 COMPLETED
Chronic Sinusitis; Nasal Polyps
Intersect ENT
 2013-01 PHASE2; PHASE3
NCT01894503 COMPLETED
Chronic Sinusitis
Intersect ENT
 2013-06 PHASE2
NCT02109185 COMPLETED
Treatment of the Signs and Symptoms of Seasonal Allergic Rhinitis
Mylan Pharmaceuticals Inc
 2013-09 PHASE1
NCT01615874 WITHDRAWN
Asthma
Organon and Co
 2013-01 PHASE2
NCT01555151 COMPLETED
Asthma
Novartis Pharmaceuticals
 2012-07 PHASE2
NCT01609478 COMPLETED
Asthma
Novartis Pharmaceuticals
 2012-08 PHASE2
NCT01333410 UNKNOWN
Vitiligo
Mahidol University
 2009-06 PHASE4
NCT01894503 Completed
Chronic Sinusitis
Intersect ENT
 2013-06 Phase 2
NCT01372865 COMPLETED
Mild to Moderate Persistent Allergic Rhinitis
Eurofarma Laboratorios S.A.
 2012-06 PHASE3
NCT01210170 COMPLETED
Asthma
University of Miami
 2010-10
NCT01386125 COMPLETED
Nasal Polyps
Organon and Co
 2011-06 PHASE3
NCT01702103 UNKNOWN
Nasal Obstruction; Sneezing; Itching
PH&T S.p.A.
 2012-10 PHASE3
NCT01702103 Unknown status
Nasal Obstruction|Sneezing|Itching
PH&T S.p.A.
 2012-10 Phase 3
NCT01673659 COMPLETED
Seasonal Allergic Rhinitis
Padagis LLC
 2012-08 PHASE3
NCT01566149 COMPLETED
Asthma
Organon and Co
 2012-03 PHASE3
NCT01523236 COMPLETED
Seasonal Allergic Rhinitis
Teva Pharmaceuticals USA
 2011-12 PHASE1; PHASE2
NCT01635088 COMPLETED
Asthma
California Allergy and Asthma Medical Group, Inc.
 2011-06 PHASE4
NCT01470053 COMPLETED
Perennial Allergic Rhinitis
Hanlim Pharm. Co., Ltd.
 2011-03 PHASE3
NCT01258803 COMPLETED
Asthma
Organon and Co
 2010-12 PHASE2
NCT01371786 COMPLETED
Allergic Rhinitis (AR)
Sumitomo Pharma America, Inc.
 2011-06 PHASE1
NCT01108198 UNKNOWN
Phimosis
University of Oulu
 2006-10 PHASE4
NCT00941798 COMPLETED
Asthma
Novartis Pharmaceuticals
 2009-07 PHASE2
NCT01165424 COMPLETED
Rhinitis, Allergic, Perennial
Organon and Co
 2010-04 PHASE3
NCT01135134 COMPLETED
Rhinitis, Allergic, Perennial
Organon and Co
 2010-06 PHASE3
NCT01228656 SUSPENDED
Plaque Psoriasis
Azidus Brasil
 2006-09 PHASE2
NCT00383721 COMPLETED
Chronic Obstructive Pulmonary Disease (COPD)
Organon and Co
 2006-09 PHASE3
NCT00383435 COMPLETED
Chronic Obstructive Pulmonary Disease (COPD)
Organon and Co
 2006-10 PHASE3
NCT01038427 COMPLETED
Rhinitis, Allergic, Seasonal
Sandoz
 2009-12-02 PHASE3
NCT00552032 COMPLETED
Adenoids Hypertrophy
Organon and Co
 2007-08-01 PHASE3
NCT00438659 COMPLETED
Breast Cancer; Dermatologic Complications; Radiation Toxicity; Skin Reactions Secondary to Radiation Therapy
North Central Cancer Treatment Group
 2007-08 PHASE3
NCT00394355 COMPLETED
Asthma
Organon and Co
 2006-09 PHASE4
NCT00553891 WITHDRAWN
Nasal Obstruction; Adenoids Hypertrophy; Adenoidectomy
Organon and Co
 2006-05 PHASE4
NCT01098071 COMPLETED
Adenoids
Organon and Co
 2008-08-01 PHASE4
NCT00687531 TERMINATED
Asthma
Organon and Co
 2006-11 PHASE4
NCT00550550 COMPLETED
Rhinoconjunctivitis; Rhinitis; Conjunctivitis; Allergy
ALK-Abelló A/S
 2007-11 PHASE3
NCT00442117 COMPLETED
Asthma
Organon and Co
 2007-06 PHASE3
NCT00635882 COMPLETED
Asthma; Airway Inflammation
Organon and Co
 2008-02 PHASE2
NCT00599027 COMPLETED
Allergic Rhinitis; Asthma
Organon and Co
 2008-05 PHASE3
NCT00746330 COMPLETED
Asthma
Novartis
 2008-08 PHASE2
NCT00521599 COMPLETED
Asthma
Organon and Co
 2007-05 PHASE4
NCT00784732 COMPLETED
Seasonal Allergic Rhinitis
Novartis
 2008-09 PHASE2
NCT00604500 COMPLETED
Asthma; COPD
Organon and Co
 2008-03-01 PHASE3
NCT00424008 COMPLETED
Asthma
Organon and Co
 2007-04 PHASE3
NCT00732381 COMPLETED
Allergic Rhinitis
Organon and Co
 2008-08 PHASE3
NCT00728416 COMPLETED
Allergic Rhinitis
Organon and Co
 2008-08 PHASE3
NCT00733005 COMPLETED
Allergic Rhinitis
Organon and Co
 2008-07 PHASE3
NCT00383240 COMPLETED
Asthma
Organon and Co
 2006-09 PHASE3
NCT00721331 COMPLETED
Atopic Dermatitis
Zalicus
 2008-07 PHASE1
NCT00383552 COMPLETED
Asthma
Organon and Co
 2006-09 PHASE3
NCT00618332 COMPLETED
Seasonal Allergic Rhinitis
University of Chicago
 2008-04
NCT00378378 COMPLETED
Nasal Polyps
Organon and Co
 2006-07 PHASE3
NCT00720382 COMPLETED
Perennial Allergic Rhinitis
Meda Pharmaceuticals
 2007-03 PHASE3
NCT00423176 TERMINATED
Sinusitis
Organon and Co
 2006-12 PHASE3
NCT00557440 COMPLETED
Asthma
Novartis
 2007-11 PHASE2
NCT00556673 COMPLETED
Asthma
Novartis
 2007-10 PHASE2
NCT00605306 COMPLETED
Asthma
Novartis
 2008-01 PHASE2
NCT00552110 COMPLETED
Seasonal Allergic Rhinitis
Organon and Co
 2007-07 PHASE2
NCT00662883 COMPLETED
Healthy
Javelin Pharmaceuticals
 2007-11 PHASE1
NCT00381485 COMPLETED
Asthma
Organon and Co
 2006-07-01 PHASE3
NCT00557739 COMPLETED
Plaque Psoriasis
Zalicus
 2007-11 PHASE2
NCT00359216 COMPLETED
Perennial Allergic Rhinitis; Obstructive Sleep Apnea; Sleep Disorder
Organon and Co
 2006-05 PHASE4
NCT00379288 COMPLETED
Asthma
Organon and Co
 2006-06 PHASE3
NCT00491504 COMPLETED
Seasonal Allergic Rhinitis
Organon and Co
 2007-02 PHASE4
NCT00468312 COMPLETED
Seasonal Allergic Rhinitis
Organon and Co
 2007-03 PHASE3
NCT00453063 COMPLETED
Seasonal Allergic Rhinitis
Organon and Co
 2007-03 PHASE3
NCT00224523 COMPLETED
Rhinitis, Allergic, Perennial
GlaxoSmithKline
 2005-09 PHASE3
NCT00358527 COMPLETED
Seasonal Allergic Rhinitis
Organon and Co
 2006-05 PHASE4
NCT00711165 COMPLETED
Asthma
Creighton University
 2005-08 PHASE4
NCT00732368 COMPLETED
Perennial Allergic Rhinitis
Organon and Co
 2005-05-01 PHASE3
NCT00783224 COMPLETED
Perennial Allergic Rhinitis
Organon and Co
 2005-09 PHASE3
NCT00731185 COMPLETED
Nasal Polyps
Organon and Co
 2003-09-01 PHASE3
NCT00779740 COMPLETED
Rhinitis, Allergic, Perennial
Organon and Co
 2005-02-01 PHASE3
NCT00783458 COMPLETED
Allergic Rhinitis
Organon and Co
 2004-12-01 PHASE4
NCT00817050 COMPLETED
Allergic Rhinitis
Organon and Co
 2004-12-01 PHASE4
NCT00779545 COMPLETED
Rhinitis, Allergic, Perennial
Organon and Co
 2004-04-08 PHASE2
NCT00751075 COMPLETED
Acute Rhinosinusitis
Organon and Co
 2003-12-01 PHASE3
NCT00834119 COMPLETED
Rhinitis, Allergic
Organon and Co
 2003-09-01 PHASE4
NCT00783237 COMPLETED
Allergic Rhinitis
Organon and Co
 2003-12-01 PHASE4
NCT00750750 COMPLETED
Acute Rhinosinusitis
Organon and Co
 2003-01-01 PHASE2
NCT00835094 COMPLETED
Asthma
Organon and Co
 2002-10-01 PHASE4
NCT03879772 COMPLETED
Rhinitis, Allergic, Seasonal
Organon and Co
 1996-03-12 PHASE3
NCT03855228 COMPLETED
Rhinitis, Allergic
Organon and Co
 1995-03-01 PHASE3
NCT03882047 COMPLETED
Rhinitis, Allergic, Seasonal
Organon and Co
 1994-08-11 PHASE3
NCT03861559 COMPLETED
Rhinitis, Allergic, Seasonal
Organon and Co
 1994-03-30 PHASE3
NCT03855189 COMPLETED
Seasonal Allergic Rhinitis
Organon and Co
 1993-08-23 PHASE3
NCT00418509 COMPLETED
Healthy
Novartis
 2006-11 PHASE1
NCT00491374 TERMINATED
Perennial Allergic Rhinitis
Schering-Plough
 2006-09 PHASE4
NCT00236106 COMPLETED
Atopic Dermatitis
Children´s Clinic, Randers
 2005-02 PHASE4
NCT00544687 COMPLETED
Healthy
Zalicus
 2007-09 PHASE1

(data from https://clinicaltrials.gov, updated on 2022-04-27)

Check the Mometasone furoate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Mometasone furoate acts as a high-affinity glucocorticoid receptor agonist that binds intracellular glucocorticoid receptors, thereby repressing pro-inflammatory gene transcription, inhibiting cytokine release, and stabilizing cellular membranes to decrease inflammatory cell influx. This localized anti-inflammatory cascade suppresses tissue swelling and hyperresponsiveness, providing therapeutic efficacy in clinical conditions such as chronic rhinosinusitis, allergic rhinitis, and asthma.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

Jump to

Note: Technical data last updated: Sep 1, 2026.