Clinical Trials

Numerous clinical trials evaluate the therapeutic potential of alpha-lipoic acid from Early Phase 1 through Phase 4 across metabolic, neurological, and inflammatory conditions, including type 2 diabetes, cardiac autonomic neuropathy, lumbosacral radicular pain, sepsis, multiple sclerosis, and polycystic ovary syndrome. Sponsored by academic and medical institutions, these studies investigate outcomes such as sepsis management, immunological responses in multiple sclerosis, and cardiovascular parameters in diabetic patients. Across this research landscape, trial recruitment statuses range from actively recruiting and completed to withdrawn.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07725484 NOT_YET_RECRUITING
Heart Failure Due to Coronary Artery Disease
Shanghai Zhongshan Hospital
 2026-11-01 PHASE3
NCT05713799 NOT_YET_RECRUITING
Insulin Resistance; Obesity
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
 2026-09-09 PHASE2
NCT07685431 RECRUITING
Female Infertility Due to Diminished Ovarian Reserve
Kaohsiung Veterans General Hospital.
 2026-06-11
NCT06286098 ENROLLING_BY_INVITATION
Hemodialysis Complication; Pediatric Kidney Disease; Cardiovascular Complication
Ain Shams University
 2025-02-02 PHASE3
NCT07785544 NOT_YET_RECRUITING
Painful Diabetic Peripheral Neuropathy
Bangladesh Medical University
 2026-08-25
NCT07501663 RECRUITING
Peripheral Neuropathy
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
 2026-01-20
NCT07564479 RECRUITING
Cisplatin Nephrotoxicity; Nephrotoxicity
Minia University
 2026-03-10 PHASE2
NCT07668141 NOT_YET_RECRUITING
Nephrotoxicity
Helwan University
 2026-06-30 PHASE3
NCT07574684 NOT_YET_RECRUITING
Advanced Non Small Cell Lung Cancer (NSCLC)
Ain Shams University
 2026-04-20 PHASE2
NCT07736495 RECRUITING
Colorectal Cancer
Ain Shams University
 2026-07-27 PHASE2; PHASE3
NCT07312123 RECRUITING
Carpal Tunnel Syndrome
Hospital Universiti Sains Malaysia
 2025-12-08
NCT04021550 WITHDRAWN
Obstructive Sleep Apnea
University of British Columbia
 2023-05 EARLY_PHASE1
NCT07630779 RECRUITING
Poly Cystic Ovary Syndrome
Beni-Suef University
 2026-03-10 PHASE3
NCT02966665 RECRUITING
Chronic Obstructive Pulmonary Disease; Pulmonary Artery Hypertension; Heart Failure; Hypertension
Russell Richardson
 2008-09 PHASE1
NCT06040190 COMPLETED
Burning Mouth Syndrome
Federal University of Minas Gerais
 2023-11-01 PHASE4
NCT07399743 NOT_YET_RECRUITING
Knee Osteoarthritis
Badr University
 2026-02-15 PHASE3
NCT07456176 NOT_YET_RECRUITING
Acute Exacerbation Chronic Obstructive Pulmonary Disease
Ain Shams University
 2026-02-28 PHASE3
NCT07182526 RECRUITING
PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries
Al-Mustansiriyah University
 2025-09-20 PHASE2
NCT07360379 NOT_YET_RECRUITING
Laparoscopic Appendectomy; Pain Management; Anti Oxidative Stress
Ain Shams University
 2025-12-28
NCT07381361 ACTIVE_NOT_RECRUITING
Burning Mouth Syndrome; Low Level Laser Therapy
Lu Jiang
 2025-04-10
NCT07455890 COMPLETED
Asthenozoospermia
Mst.Sumyara Khatun
 2024-07-01
NCT06650384 COMPLETED
Nephrotoxicity
Ain Shams University
 2024-11-01 PHASE2; PHASE3
NCT07157722 NOT_YET_RECRUITING
Beta Thalassemia
Tanta University
 2025-08-30 PHASE3
NCT06201611 RECRUITING
Diabetic Neuropathy Peripheral
St. John's Research Institute
 2024-11-15 PHASE2; PHASE3
NCT07256119 RECRUITING
Prevention
Ain Shams University
 2024-08-06
NCT06418347 UNKNOWN
Polycystic Ovary Syndrome; Infertility, Female
Ain Shams University
 2024-04-01 PHASE3
NCT06661993 COMPLETED
Sepsis
Damanhour University
 2024-10-15
NCT05371288 WITHDRAWN
COVID-19
University of California, Irvine
 2025-06 EARLY_PHASE1
NCT06067698 RECRUITING
Ulcerative Colitis; Ulcerative Colitis (UC)
Tanta University
 2023-10-01
NCT06406127 UNKNOWN
Breast Cancer; Alpha Lipoic Acid; Paclitaxel; Neurologic Disorder; Chemotherapy
Ain Shams University
 2024-04-01 PHASE4
NCT06703593 COMPLETED
Breast Cancer Female
British University In Egypt
 2023-10-01 PHASE2
NCT04881851 TERMINATED
Polycystic Ovary Syndrome
Universita di Verona
 2015-05-07
NCT03491969 COMPLETED
Ischemic Heart Failure
Shanghai Zhongshan Hospital
 2019-01-01 PHASE4
NCT07022938 COMPLETED
Cancer; Neuropathy; Chemotherapy Induced Pain Neuropathy; Chemotherapy-Induced Peripheral Neuropathy
Aristotle University Of Thessaloniki
 2021-11-01 PHASE4
NCT02910531 COMPLETED
Cystinuria
Thomas Chi, MD
 2017-06-19 PHASE2
NCT06568185 UNKNOWN
Diabetic Polyneuropathy
Universiti Sains Malaysia
 2024-05-27 PHASE2
NCT05808946 UNKNOWN
Sepsis
Ain Shams University
 2023-03-10 PHASE2; PHASE3
NCT05679037 UNKNOWN
Diabetes MellitusType 1
Tanta University
 2023-01 PHASE3
NCT06940557 COMPLETED
Carpal Tunnel Syndrome (CTS)
Universiti Putra Malaysia
 2023-12-01 PHASE2; PHASE3
NCT05813496 COMPLETED
Polyneuropathy, Diabetic
Eva Pharma
 2022-10-26 PHASE4
NCT05945160 WITHDRAWN
Vestibular Function Disorder
The University of Texas Health Science Center at San Antonio
 2024-01 EARLY_PHASE1
NCT07391709 COMPLETED
Priapism; Reperfusion Injury
Trabzon Kanuni Education and Research Hospital
 2024-02-10
NCT06121713 COMPLETED
Nutrition, Healthy
University of Toronto
 2024-02-08
NCT05507697 UNKNOWN
Diabetic Peripheral Neuropathy Type 2
Wuhan Central Hospital
 2022-05-19 PHASE1; PHASE2
NCT06137066 COMPLETED
Healthy
Dr. Chris McGlory, PhD
 2023-12-01
NCT06122012 UNKNOWN
Diabetic Peripheral Neuropathic Pain
Haisco Pharmaceutical Group Co., Ltd.
 2023-05-01
NCT06151652 UNKNOWN
Postoperative Atrial Fibrillation
Ain Shams University
 2023-01-01 PHASE4
NCT06056687 COMPLETED
Ischemic Cardiomyopathy; Diabetes Mellitus
Damanhour University
 2023-03-01
NCT06253429 UNKNOWN
Type 1 Diabetes
Ain Shams University
 2023-01-01 PHASE3
NCT05913986 UNKNOWN
Metabolic Associated Fatty Liver Disease
Saluz Investigación S. C.
 2023-03-01
NCT03161028 COMPLETED
Multiple Sclerosis
VA Office of Research and Development
 2018-08-17 PHASE2
NCT04475276 COMPLETED
Non-Alcoholic Fatty Liver Disease
All India Institute of Medical Sciences, Bhubaneswar
 2021-02-23 PHASE4
NCT06131918 COMPLETED
Peripheral Diabetic Neuropathy
Khyber Medical University Peshawar
 2023-01-09 PHASE2
NCT04141475 TERMINATED
Diabetic Cardiomyopathies
Centre Hospitalier Universitaire de Nice
 2020-11-24
NCT05369793 COMPLETED
Type 2 Diabetes (Adult Onset); Diabetic Neuropathies
Tanta University
 2022-08-01 PHASE3
NCT05449171 COMPLETED
Abortion, Spontaneous
Lo.Li.Pharma s.r.l
 2022-09-01
NCT05009901 UNKNOWN
Obstructive Sleep Apnea of Adult
University of British Columbia
 2022-06-01 PHASE2; PHASE3
NCT05360602 COMPLETED
No-Reflow Phenomenon
Ain Shams University
 2022-01-01
NCT06195137 COMPLETED
Caffeine; Burning Mouth Syndrome
Lu Jiang
 2021-12-13
NCT05729529 UNKNOWN
Burning Mouth Syndrome
University of Catania
 2020-01-20
NCT05231980 COMPLETED
Clomiphene Citrate; Resistant Ovary Syndrome; Polycystic Ovary Syndrome
Ain Shams University
 2022-06-05 PHASE2
NCT05571748 UNKNOWN
G6PD Deficiency; Carbohydrate Metabolism Disorder; Oxidative Stress
University of Thessaly
 2023-02
NCT05808946 Recruiting
Sepsis
Ain Shams University
 2023-03-10 Phase 2|Phase 3
NCT04846673 COMPLETED
Diabetic Peripheral Neuropathy
Yuhan Corporation
 2021-05-14 PHASE4
NCT04518540 UNKNOWN
Amyotrophic Lateral Sclerosis
Second Affiliated Hospital, Zhejiang University, School of Medicine
 2020-09-01
NCT05984771 COMPLETED
Diabetic Neuropathies; Diabetes Mellitus; Dietary Supplement
Aristotle University Of Thessaloniki
 2021-01-10
NCT04874285 COMPLETED
Pregnancy, High Risk
Lo.Li.Pharma s.r.l
 2021-05-03
NCT05023863 UNKNOWN
Radiation-Induced Mucositis
Ain Shams University
 2021-09-01 PHASE2; PHASE3
NCT05485259 COMPLETED
Low-Grade Squamous Intraepithelial Lesions
University of Zagreb
 2020-01-15
NCT03788759 COMPLETED
Schizophrenia; Oxidative Stress
Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara
 2019-09-01 PHASE2; PHASE3
NCT04041167 UNKNOWN
Stroke, Ischemic
Chonnam National University Hospital
 2018-08-01 PHASE3
NCT06787781 COMPLETED
Metabolic Evaluation; Cardiac Complications
University of Messina
 2021-06-01
NCT04064814 COMPLETED
Adolescent Migraine
All India Institute of Medical Sciences, Bhubaneswar
 2019-09-14 PHASE4
NCT04042935 COMPLETED
HNSCC
University of Colorado, Denver
 2020-02-27 PHASE1
NCT03908528 COMPLETED
Breast Cancer; Chemotherapeutic Toxicity
Damanhour University
 2019-03-01
NCT04322240 COMPLETED
Diabetic Polyneuropathy; Diabetes Mellitus, Type 2
Benha University
 2020-04-02
NCT03952533 COMPLETED
Cervical Shortening; Preterm Birth
University of Modena and Reggio Emilia
 2019-05-05
NCT04436419 COMPLETED
Obesity; Obesity, Abdominal; Obesity, Visceral; Female
Fauqué
 2018-07-02
NCT03912727 COMPLETED
Hemodialysis Complication
Rehab Werida
 2019-04-11
NCT03589690 UNKNOWN
Metabolic Syndrome
Dr. B.Abbasi
 2018-07-25
NCT05266794 COMPLETED
Antioxidative Stress; End Stage Renal Disease on Dialysis
Ain Shams University
 2019-01-22 PHASE4
NCT02613572 COMPLETED
Age-Related Macular Degeneration
University of Pennsylvania
 2015-11 PHASE1; PHASE2
NCT03493841 COMPLETED
Multiple Sclerosis; Progressive Multiple Sclerosis; Secondary Progressive Multiple Sclerosis; Primary Progressive Multiple Sclerosis
Rebecca Spain
 2018-06-08 PHASE1
NCT03612037 COMPLETED
PreDiabetes
State University of New York at Buffalo
 2016-09-01
NCT02971878 COMPLETED
Culture Media; Blastocyst; Antioxidants; Embryo; Human
Fertilitetscentrum AB
 2016-11
NCT03257514 COMPLETED
Cesarean Section; Dehiscence; Cesarean Scar Niche
Ain Shams University
 2017-06-01 PHASE2
NCT02760823 UNKNOWN
Toxicity
Heba Allah Ali Abd El-Halim Mabrouk
 2016-05 PHASE2
NCT01177189 TERMINATED
Aging
VA Office of Research and Development
 2011-07-01
NCT02937363 COMPLETED
G6PD Deficiency
University of Thessaly
 2016-12
NCT03428139 COMPLETED
Radicular; Neuropathic, Lumbar, Lumbosacral
Assiut University
 2013-08-20 PHASE2
NCT03062163 COMPLETED
Lipolysis
Chulalongkorn University
 2017-01-23
NCT01294176 COMPLETED
Optic Neuritis
Oregon Health and Science University
 2011-01 PHASE1
NCT02666170 UNKNOWN
Polycystic Ovary Syndrome
Catholic University of the Sacred Heart
 2016-01
NCT03342599 COMPLETED
Metabolic Syndrome; Obesity
University of La Verne
 2013-10
NCT02775266 COMPLETED
Diabetes Mellitus; Periodontitis
Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
 2016-02
NCT02382328 COMPLETED
Carpal Tunnel Syndrome
Hospital Civil de Guadalajara
 2016-02 PHASE2
NCT03023514 COMPLETED
Women Infertility
Lo.Li.Pharma s.r.l
 2015-03 PHASE4
NCT02133664 COMPLETED
Multiple Sclerosis; Cognition
Oregon Health and Science University
 2014-06 PHASE1; PHASE2
NCT01880372 TERMINATED
Moderate Non-proliferative Diabetic Retinopathy
Ferris State University
 2013-09
NCT01381354 COMPLETED
Multiple Sclerosis
University of Iowa
 2010-10 PHASE1
NCT01524861 COMPLETED
Apical Ballooning Syndrome; Nervous System Diseases, Sympathetic
University of Campania Luigi Vanvitelli
 2011-12 PHASE4
NCT02601898 COMPLETED
Subchorionic Hematoma in the First Trimester Pregnancy; Miscarriage
Azienda USL Ferrara
 2015-01 PHASE4
NCT01780974 COMPLETED
Treated Hypertension
Oregon Health and Science University
 2013-04 PHASE1; PHASE2
NCT01188811 COMPLETED
Multiple Sclerosis, Chronic Progressive
VA Office of Research and Development
 2010-10 PHASE2; PHASE3
NCT01877590 COMPLETED
Type 2 Diabetes; Coronary Artery Disease; Left Ventricular Mass
Wuhan General Hospital of Guangzhou Military Command
 2013-11 PHASE4
NCT02651636 COMPLETED
Polycystic Ovary Syndrome; Menstrual Pattern; Hyperandrogenism; Metabolic Features
Catholic University of the Sacred Heart
 2014-06
NCT04214665 COMPLETED
Peripheral (Sensorimotor) Diabetic Polyneuropathy
Ilko Ilac San. ve Tic. A.S.
 2014-12-30 PHASE1
NCT01058941 COMPLETED
Alzheimer's Disease
Oregon Health and Science University
 2010-09 PHASE1; PHASE2
NCT01895621 COMPLETED
Entrapment Neuropathy, Carpal Tunnel; Compression Neuropathy, Carpal Tunnel; Median Neuropathy, Carpal Tunnel
Istituto Ortopedico Rizzoli
 2013-03 PHASE4
NCT01978405 UNKNOWN
Acute Kidney Injury; The Changes of Plasma Creatinine; The Changes of Plasma Free Radicals; The Changes of Endothelium-dependent Arterial Dilation
Xiang Guang-da
 2013-11 PHASE4
NCT00112996 COMPLETED
Neurotoxicity; Unspecified Adult Solid Tumor, Protocol Specific; Unspecified Childhood Solid Tumor, Protocol Specific
M.D. Anderson Cancer Center
 2007-01 PHASE3
NCT01650181 COMPLETED
Liver Disease
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
 2011-11 PHASE4
NCT01984567 UNKNOWN
Oxidative Stress
Maastricht University Medical Center
 2013-04
NCT00997438 COMPLETED
Multiple Sclerosis
Portland VA Medical Center
 2010-08 PHASE1
NCT01495260 COMPLETED
Adrenomyeloneuropathy
Pujol, Aurora, M.D.
 2011-09 PHASE2
NCT01877590 Completed
Type 2 Diabetes|Coronary Artery Disease|Left Ventricular Mass
Wuhan General Hospital of Guangzhou Military Command
 2013-11 Phase 4
NCT01537549 COMPLETED
Progressive Supranuclear Palsy
Weill Medical College of Cornell University
 2010-09-14 PHASE1; PHASE2
NCT01888861 UNKNOWN
Oxidative Stress; Inflammation; Malnutrition
najmeh hejazi
 2013-02 PHASE3
NCT02056366 COMPLETED
Type 2 Diabetes; Cardiac Autonomic Neuropathy
The Catholic University of Korea
 2010-01 PHASE4
NCT01313117 COMPLETED
Peripheral Neuropathy
Northwestern University
 2012-02 PHASE1; PHASE2
NCT01895699 Completed
Contrast Agent|Endothelial Function|Cytokines|Apoptosis of Endothelial Progenitor Cell|Free Radical|Alpha-lipoic Acid
Xiang Guang-da|Wuhan General Hospital of Guangzhou Military Command
 2013-07 Phase 4
NCT01696448 COMPLETED
Metabolic Syndrome
Carmel Biosciences
 2012-08
NCT01054768 COMPLETED
Anemia, Sickle Cell
UCSF Benioff Children's Hospital Oakland
 2009-08 PHASE2
NCT02016495 COMPLETED
Pregnancy
AGUNCO Obstetrics and Gynecology Centre
 PHASE4
NCT00962429 COMPLETED
CIDP; Chronic Inflammatory Demyelinating Polyneuropathy
Oregon Health and Science University
 2009-02 PHASE2
NCT01396733 WITHDRAWN
Thyroid; Cancer
Asan Medical Center
 2011-04 PHASE2
NCT01355952 COMPLETED
Obesity; Weight Loss; Schizophrenia
Yale University
 2011-05
NCT00857376 COMPLETED
Metabolic Syndrome
Johns Hopkins University
 2008-03 PHASE2
NCT01221350 COMPLETED
Asthma; Allergic Rhinitis
Centro Universitario de Ciencias de la Salud, Mexico
 2010-11
NCT01261143 COMPLETED
Diabetic Neuropathies
Bukwang Pharmaceutical
 2010-08 PHASE3
NCT01138774 COMPLETED
Obesity; Body Fat; Insulin Resistance
Clinica Universidad de Navarra, Universidad de Navarra
 2010-01
NCT00764270 COMPLETED
Atherosclerosis
Oregon State University
 2011-08-01 PHASE2; PHASE3
NCT00765310 COMPLETED
Atherosclerosis
Oregon State University
 2009-04-01 PHASE1
NCT00719706 COMPLETED
Bipolar Depression
Mclean Hospital
 2008-08 PHASE2
NCT00122447 COMPLETED
Impaired Glucose Tolerance; Prediabetic State
Emory University
 2005-05
NCT01224353 UNKNOWN
Diabetics
NovaMed Pharmaceuticals Inc.
 2010-11 PHASE2; PHASE3
NCT00477607 COMPLETED
Ototoxicity; Unspecified Adult Solid Tumor
US Department of Veterans Affairs
 2007-10 PHASE2; PHASE3
NCT00398892 WITHDRAWN
Diabetes Mellitus, Type 2
University of Edinburgh
 2009-12 PHASE2
NCT01056497 COMPLETED
Type 2 Diabetes; Prediabetes
University Health Network, Toronto
 2010-02 PHASE4
NCT01406704 TERMINATED
NASH (Non-alcoholic Steato-hepatitis)
Seoul St. Mary's Hospital
 2004-01 PHASE4
NCT02439879 COMPLETED
Diabetic Neuropathy
Universidad Popular Autónoma del Estado de Puebla
 2009-12 PHASE4
NCT00845156 COMPLETED
Insulin Resistance
University of California, San Francisco
 2008-01
NCT00237718 COMPLETED
End-stage Renal Disease
Vanderbilt University
 2006-04 PHASE2
NCT00505427 COMPLETED
Insulin Resistance; Oxidative Stress
University of California, San Francisco
 2006-03 PHASE1
NCT00994513 COMPLETED
Obesity; Cardiovascular Disease; Type 2 Diabetes
Augusta University
 2009-07 PHASE2; PHASE3
NCT02056366 Completed
Type 2 Diabetes|Cardiac Autonomic Neuropathy
The Catholic University of Korea
 2010-01 Phase 4
NCT00795262 COMPLETED
Diabetes; Hypertension
InVasc Therapeutics, Inc.
 2008-07
NCT00676156 COMPLETED
Multiple Sclerosis
Oregon Health and Science University
 2005-12 PHASE1
NCT00117403 COMPLETED
Alzheimer's Disease
National Institute on Aging (NIA)
 2006-01 PHASE1
NCT00308971 COMPLETED
Chronic Kidney Disease
Vanderbilt University
 2006-03 PHASE2
NCT00079807 COMPLETED
HIV; Peripheral Neuropathy
National Center for Complementary and Integrative Health (NCCIH)
 2003-09 PHASE1; PHASE2
NCT00703989 COMPLETED
Type 1 Diabetes
Albert Einstein College of Medicine
 2005-02
NCT00090402 COMPLETED
Alzheimer's Disease; Oxidative Stress; Dementia; Hyperlipidemia; Inflammation
Oregon Health and Science University
 2004-04 PHASE1; PHASE2
NCT01208948 COMPLETED
Diabetes Mellitus; Macular Edema
Ludwig-Maximilians - University of Munich
 2000-07 PHASE3
NCT00187564 COMPLETED
Diabetes Mellitus, Type 1
University of California, San Francisco
 2004-08
NCT00033176 COMPLETED
Acquired Immunodeficiency Syndrome; HIV Infections
National Center for Complementary and Integrative Health (NCCIH)
 2002-02 PHASE2
NCT00065624 COMPLETED
Hypercholesterolemia
National Center for Complementary and Integrative Health (NCCIH)
 2003-11 PHASE2
NCT00490867 COMPLETED
Type 2 Diabetes
Medical University of Vienna
 2004-07 PHASE2
NCT00010842 COMPLETED
Multiple Sclerosis
National Center for Complementary and Integrative Health (NCCIH)
 1999-09 PHASE1; PHASE2

(data from https://clinicaltrials.gov, updated on 2026-08-05)

Check the (+)-α-Lipoic acid product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

As an essential mitochondrial enzyme cofactor and potent antioxidant, (+)-alpha-lipoic acid inhibits nuclear factor kappa B activation to suppress downstream pro-inflammatory gene expression and reactive oxygen species generation. This mitigation of oxidative stress and inflammatory signaling preserves cellular and neurovascular function, supporting its clinical evaluation for conditions such as diabetic neuropathy, type 2 diabetes, and sepsis.

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>).

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