In vivo fasted-state bioequivalence study of Chlordiazepoxide 10 mg Tablets manufactured by Mehrdarou Pharmaceutical Co. compared to innovator product

Start Date20 Nov 2024

Sponsor / Collaborator

Tabriz University of Medical Sciences

CTRI/2021/03/031971

/ RecruitingPhase 4

A Prospective, single arm, Multi-centric, Active, Post Marketing Surveillance Study for evaluation of safety and efficacy of FDC of Amitriptyline and Chlordiazepoxide tablets of Dr. Reddys Laboratories Ltd in management of depression with co-morbid anxiety

Start Date20 Mar 2021

Sponsor / Collaborator

Dr. Reddy's Laboratories Ltd.

CTRI/2020/07/026583

/ CompletedPhase 4

An open Label,multicentre Post-Marketing Surveillance study to Monitor the Safety and Efficacy of Combination Therapy of Amitriptyline 12.5mg/25mg and Chlordiazepoxide 5mg/10mg in Subjects with Major Depressive Disorder with Associated Anxiety in Regular Practice

Start Date15 Jul 2020

Sponsor / Collaborator-

100 Clinical Results associated with Chlordiazepoxide

100 Translational Medicine associated with Chlordiazepoxide

100 Patents (Medical) associated with Chlordiazepoxide

4,822

Literatures (Medical) associated with Chlordiazepoxide

02 Sep 2025·INTERNATIONAL JOURNAL OF ENVIRONMENTAL ANALYTICAL CHEMISTRY

Development and application of a sustainable approach for the determination of 95 pharmaceutical substances and metabolites in urban wastewater by means of ultra-high-performance liquid-chromatography-tandem mass spectrometry

Author: Vincenti, Marco ; Gerace, Enrico ; Minella, Marco ; Privitera, Dana ; Massano, Marta ; Salomone, Alberto ; Alladio, Eugenio

In the last few years, the interest in pharmaceutical drugs and their metabolites as environmental pollutants is gaining growing importance.Regular monitoring and timely actions are decisive to implement appropriate water resource management strategies and to evaluate the efficiency of traditional or innovative wastewater treatment plants (WWTPs).This study describes the development and validation of an anal. procedure using 10 mL sample volume followed by direct-injection in ultra-high-performance liquid chromatog.-tandem mass spectrometry (UHPLC-MS/MS) for the simultaneous determination of 95 pharmaceutical drugs and 10 of their main metabolites in wastewater.Adequate sensitivity was recorded for all target analytes, with limits of detection below 5 ng/L for 60 out of 95 analytes and recoveries exceeding 80% for all the analytes under study.A total of 42 target analytes were detected in almost all sites, and limited differences were observed among several pharmaceutical drug arrays found at different sampling sites.In addition, an abatement yield higher than 50% was observed for only 12 of the 42 detected substances.The procedure, which combined direct injection and small sample volume collection, showed great potential and efficiency for the high-performance determination of pharmaceutical drugs in wastewater.

01 Sep 2025·HUMAN PSYCHOPHARMACOLOGY-CLINICAL AND EXPERIMENTAL

National Prescribing Trends and Cost Analysis of Antidepressants, Anxiolytics, and Hypnotics in England, 2010–2023

Article

Author: Levy, John Warner‐ ; Ingram, Joseph ; Davies, Mark ; Heald, Adrian ; Taylor, David ; Stedman, Mike

ABSTRACT:

Introduction:

We describe prescribing of anxiolytics/hypnotics/antidepressants at an all‐England level between 2010 and 2023, taking account of the influence of the COVID‐19 pandemic‐period.

Methods:

All Primary Care Prescribing data for England for anxiolytics/hypnotics/antidepressant agents taken as tablets or capsules from 1 January 2010 to 31 December 2023 were considered.

Results:

Antidepressants: the greatest increases were in sertraline prescriptions increasing from 2.9million 2010 by 685% to 23.0 million‐2023; duloxetine increased by 545% to 3.9million prescriptions; mirtazapine by 269% to 12.4million prescriptions. Regarding cost, overall average cost fell 2010‐2023 by 54% from £4.86(Euros 5.68) to £2.25(Euros 2.63) per prescription. Anxiolytics: the number of prescriptions for anxiolytics fell 6.5–4.8 m (−27%) overall, with all anxiolytics falling except buspirone. The greatest period of fall was seen between 2018 and 2023. Lorazepam/diazepam/chlordiazepoxide were down 23%,16%, 88% respectively. Average cost of prescriptions fell by 13% to £3.20(Euros 3.74). Hypnotics: the number of prescriptions for hypnotics fell 41% from 9.8million to 5.8million in 2023. All prescriptions fell in number. Annual trends showed no deviations for the COVID‐19 core pandemic (2020/2021) years.

Conclusion:

Overall trends demonstrate a more than doubling of antidepressant prescribing over the period 2010–2023, with similar volume reduction in anxiolytics/hypnotics over the same period. Such real world data facilitate the development of policy influencing insights for psychotropic prescribing management now and in coming years.

01 Aug 2025·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Utilizing copper-doped graphene quantum dots as a fluorescent sensor for determination of carbamazepine in exhaled breath condensate

Article

Author: Jouyban-Gharamaleki, Vahid ; Rahimpour, Elaheh ; Khoubnasabjafari, Maryam ; Keyvani, Aylar ; Jouyban, Abolghasem ; Soleymani, Jafar

Carbamazepine is a versatile pharmaceutical used mainly for epilepsy and mood stabilization, but like all medications, it requires careful monitoring due to its potential side effects and interactions. In the current work, a fluorescent nanosensor was developed for the carbamazepine determination in the exhaled breath condensate (EBC). The nanosensor consists of graphene quantum dots doped with copper (Cu-doped GQDs). The presence of carbamazepine significantly decreased the fluorescence of Cu-doped GQDs, resulting in a quenching effect within a concentration range of 0.02-2.0 µg/mL, which occurs due to dynamic, rather than static, quenching according to Stern-Volmer plot. The relative standard deviations for intra-day and inter-day analysis of carbamazepine were 1.8 % and 4.8 %, respectively. The validated sensor was effectively employed for carbamazepine analysis in EBC of patients receiving the drug.

News (Medical) associated with Chlordiazepoxide

23 Aug 2024

·pharma.economictimes.indiatimes.com

Govt bans 156 medicines including antibiotics, painkillers, multivitamins: Here is the full list

New Delhi: In a significant move aimed at safeguarding public health, the Indian government has banned 156 fixed-dose combination (FDC) drugs, including a variety of antibiotics, painkillers, multivitamins, and medications for treating fever and hypertension. This decision marks the largest crackdown on FDCs since 2016, when 344 such drugs were prohibited. The Union Ministry of Health and Family Welfare issued a gazette notification on Thursday, officially prohibiting the manufacture, sale, and distribution of the banned FDCs. The ban was based on the recommendations of an expert panel that reviewed a total of 324 FDCs. Impact on Pharmaceutical Industry The banned FDCs include popular combinations such as mefenamic acid and paracetamol injections, commonly used for pain relief and fever, and omeprazole magnesium with dicyclomine HCl, used to treat abdominal pain. The ban is expected to impact major pharmaceutical companies, including Sun Pharmaceuticals, Cipla, Dr. Reddy's Laboratories, Torrent Pharmaceuticals, and Alkem Laboratories. Fixed Dose Combinations Drug Banned List Here is a table listing all 156 banned Fixed Dose Combinations (FDCs) SN Fixed Dose Combination (FDC) 1 Amylase + Protease + Glucoamylase + Pectinase + Alpha Galactosidase + Lactase + Beta-Gluconase + Cellulase + Lipase + Bromelain + Xylanase + Hemicellulase + Malt diastase + Invertase + Papain 2 Antimony Potassium Tartrate + Dried Ferrous Sulphate 3 Benfotiamine + Silymarin + L-Ornithine L-aspartate + Sodium Selenite + Folic acid + Pyridoxine hydrochloride 4 Bismuth Ammonium Citrate + Papain 5 Cyproheptadine HCl + Thiamine HCl + Riboflavine + Pyridoxine HCl + Niacinamide 6 Cyproheptadine Hydrochloride + Tricholine Citrate + Thiamine Hydrochloride + Riboflavine + Pyridoxine Hydrochloride 7 Rabeprazole Sodium (As enteric coated tablet) + Clidinium Bromide + Dicyclomine HCl + Chlordiazepoxide 8 Fungal Diastase + Papain + Nux vomica Tincture + Cardamom Tincture + Casein Hydrolysed + Alcohol 9 Mefenamic Acid + Paracetamol Injection 10 Omeprazole Magnesium + Dicyclomine HCl 11 S-adenosyl methionine + Metadoxine + Ursodeoxycholicacid BP + L-Methylfolate Calcium eq. to L- Methylfolate + Choline bitartratee + Silymarin + L-ornithine Laspartate + Inositol + Taurine 12 Silymarin + Thiamine Mononitrate + Riboflavin + Pyridoxine HCl + Niacinamide + Calcium pantothenate + Vitamin B12 13 Silymarin + Pyridoxine HCl + Cyanocobalamin + Niacinamide + Folic Acid 14 Silymarin + Vitamin B6 + Vitamin B12 + Niacinamide + Folic acid + Tricholine Citrate 15 Sodium Citrate + Citric Acid Monohydrate Flavored with Cardamom Oil, Caraway Oil, Cinnamon Oil, Clove Oil, Ginger Oil + Alcohol 16 Sucralfate + Acelofenac 17 Sucralfate + Domperidone + Dimethicone 18 Sucralfate + Domperidone 19 Tincture Ipecacuanha + Tincture Urgenia + Camphorated Opium Tincture + Aromatic Spirit of Ammonia + Chloroform + Alcohol 20 Ursodeoxycholic Acid + Metformin HCl 21 Weak Ginger tincture + Aromatic Spirit of Ammonia + Peppermint Spirit + Chloroform + Sodium Bicarbonate + Compound Cardamom + Alcohol 22 Sucralfate + Pantoprazole Sodium + Zinc Gluconate + Light Magnesium Carbonate 23 Aloe + Vitamin E Soap 24 Povidone Iodine+ Metronidazole + Aloe 25 Azelaic acid + Tea Tree Oil + Salicylic acid + Allantoin + Zinc oxide + Aloe vera + Jojoba oil + Vitamin E + Soap noodles 26 Azithromycin + Adapalene 27 Calamine + Aloes + Allantoin 28 Calamine + Diphenhydramine Hydrochloride + Aloe + Glycerine + Camphor 29 Chlorphenesin + Zinc oxide + Starch 30 Clindamycin Phosphate + Zinc acetate 31 Gamma Benzene Hexachloride + Benzocaine 32 Glucosamine hydrochloride + Diacerein + Menthol + Camphor + Capsaicin 33 Hydroxyquinone 2.0%w/w + Octyl Methoxycinnamate 5.0% w/w + Oxybenzone 30 % w/w 34 Ketoconazole +Zinc Pyrithione +D-Panthenol +Tea Tree Oil +Aloes 35 Ketoconazole +Aloe vera+ Vitamin A Acetate 36 Ketoconazole +Aloes + ZPTO 37 Kojic Acid +Arbutin +Octinoxate +Vitamin E + Mulberry 38 Lornoxicam +capsaicin +menthol+ camphor 39 Lornoxicam + Thiocolchicoside +Oleum Lini +Menthol + Methyl salicylate 40 Menthol + Aloe vera Topical Spray 41 Menthol +Lignocaine HCl +Aloe vera gel +Clotrimazole +Diphenhydramine 42 Miconazole nitrate + Gentamicin + Fluocinolone Acetonide +Zinc Sulphate 43 Miconazole +Tinidazole 44 Minoxidil +Aminexil+ Alcohol 45 Minoxidil +Azelaic acid + saw palmetto 46 Minoxidil +Aminexil 47 Pine Bark extract+ Kojic acid +Sodium Ascorbyl Phosphate 48 Povidone Iodine +Tinidazole +Zinc sulphate 49 Povidone Iodine + Ornidazole + Dexpanthenol 50 Salicyclic acid +Aloe vera+ Allantoin +D-Panthenol 51 Silver sulphadiazine +Chlorhexidine Gluconate solution +Allantoin + Aloe vera gel +Vitamin E acetate 52 Sodium salicylate + Zinc gluconate + Pyridoxine HCl 53 Tetracycline + Colistin Sulphate 54 Clomiphene +Ubidecarenone 55 Combikit of Clomiphene Citrate + Estradiol Valerate 56 Flavoxate HCl +Ofloxacin 57 Clomiphene Citrate +N-Acetylcysteine 58 Primerose Oil +Cod liver oil 59 Sildenafil Citrate +Papaverine +L-Arginine 60 Tranexamic acid +Mefenamic acid + Vitamin K1 61 Divalproex Sodium +Oxcarbazepine 62 Divalproex Sodium + Levetiracitam 63 Ergotamine tartrate +Caffeine + Paracetamol +Prochlorperazine maleate 64 Piracetam + Ginkgo biloba extracts + Vinpocetin 65 Ginkgo biloba + methylcobalamin 66 Ginkgo biloba + methylcobalamin + Alpha lipoic acid +Pyridoxine HCl 67 Ginseng Extract +Dried extract of Ginkgo Biloba 68 Meclizine HCl+ Paracetamol + Caffeine 69 Nicergoline + Vinpocetine 70 Gamma Linolenic Acid + Methylcobalamin 71 Beclomethasone Dipropionate + Neomycin Sulphate + Clotrimazole + Lignocaine HCl 72 Boric acid+ Phenylephrine HCl + Naphazoline Nitrate + Menthol + Camphor 73 Naphazoline HCl + Chlorpheniramine Maleate + Zinc Sulphate + Hydroxy Propyl Methyl Cellulose 74 Chlorpheniramine Maleate + Naphazoline HCl + Zinc Sulphate + Sodium Chloride + Hydroxy Propyl Methyl Cellulose 75 Chlorpheniramine Maleate + Naphazoline HCl + Hydroxy Propyl Methyl Cellulose 76 Chlorpheniramine Maleate + Sodium Chloride + Boric Acid + Tetrahydrozoline HCl 77 Chlorpheniramine Maleate + Phenylephrine HCl + Antipyrine 78 Ketorolac Tromethamine + Chlorpheniramine Maleate + Phenylephrine HCl + Hydroxy Propyl Methyl Cellulose 79 Ketorolac Tromethamine + Flurometholone 80 Naphazoline HCl + Zinc Sulphate + Boric Acid + Sodium Chloride+ Chlorpheniramine Maleate 81 Naphazoline HCl + Hydroxy Propyl Methyl Cellulose + Boric Acid + Borax + Menthol + Camphor 82 Naphazoline HCl + Hydroxy Propyl Methyl Cellulose + Chlorpheniramine Maleate SN Fixed Dose Combination (FDC) 83 Diphenhydramine Hydrochloride + Phenylephrine Hydrochloride + Menthol + Camphor 84 Diphenhydramine Hydrochloride + Phenylephrine Hydrochloride + Sodium Chloride + Hydroxy Propyl Methyl Cellulose 85 Diphenhydramine Hydrochloride + Phenylephrine Hydrochloride + Sodium Chloride + Methylparaben 86 Methenamine + Sodium Benzoate + Benzyl Alcohol 87 Paracetamol + Phenylephrine Hydrochloride + Chlorpheniramine Maleate 88 Paracetamol + Phenylephrine Hydrochloride + Chlorpheniramine Maleate + Caffeine 89 Propoxyphene + Chlorpheniramine Maleate 90 Propoxyphene + Phenylephrine Hydrochloride + Chlorpheniramine Maleate 91 Propoxyphene + Diphenhydramine Hydrochloride + Phenylephrine Hydrochloride 92 Sodium Benzoate + Sodium Citrate + Citric Acid 93 Vitamin A Palmitate + Vitamin C + Vitamin E + Vitamin B6 + Vitamin B12 94 Vitamin A Palmitate + Vitamin C + Vitamin E + Niacinamide 95 Vitamin B6 + Vitamin B12 + Vitamin C 96 Vitamin B6 + Vitamin B12 + Niacinamide 97 Vitamin B12 + Vitamin B6 + Vitamin C + Folic Acid 98 Vitamin B12 + Vitamin B6 + Niacinamide + Folic Acid 99 Vitamin C + Vitamin E + Vitamin A + Niacinamide 100 Vitamin D + Calcium + Magnesium 101 Vitamin D + Calcium + Magnesium + Zinc 102 Calcium + Vitamin D + Vitamin K 103 Calcium + Vitamin D + Magnesium + Zinc 104 Calcium + Vitamin D + Vitamin K + Magnesium 105 Calcium + Vitamin D + Vitamin K + Magnesium + Zinc 106 Vitamin E + Vitamin A + Vitamin C + Niacinamide 107 Vitamin E + Vitamin A + Vitamin C + Folic Acid 108 Vitamin E + Vitamin A + Vitamin C + Biotin 109 Vitamin E + Vitamin A + Vitamin C + Vitamin B12 110 Vitamin E + Vitamin C + Folic Acid 111 Vitamin E + Vitamin C + Biotin 112 Vitamin E + Vitamin C + Vitamin B12 113 Vitamin E + Vitamin C + Zinc 114 Calcium + Vitamin D + Omega-3 Fatty Acids 115 Calcium + Vitamin D + Omega-3 Fatty Acids + Vitamin K 116 Calcium + Vitamin D + Omega-3 Fatty Acids + Vitamin K + Magnesium 117 Calcium + Vitamin D + Omega-3 Fatty Acids + Vitamin K + Zinc 118 Vitamin A + Vitamin C + Vitamin E + Beta-Carotene 119 Vitamin A + Vitamin C + Vitamin E + Beta-Carotene + Zinc 120 Vitamin C + Vitamin E + Beta-Carotene 121 Vitamin C + Vitamin E + Beta-Carotene + Zinc 122 Vitamin C + Vitamin E + Selenium 123 Vitamin D + Calcium + Vitamin K + Omega-3 Fatty Acids 124 Vitamin D + Calcium + Vitamin K + Omega-3 Fatty Acids + Magnesium 125 Vitamin D + Calcium + Vitamin K + Omega-3 Fatty Acids + Zinc 126 Vitamin D + Calcium + Vitamin K + Omega-3 Fatty Acids + Biotin 127 Vitamin D + Calcium + Omega-3 Fatty Acids + Vitamin K + Selenium 128 Vitamin E + Vitamin A + Vitamin C + Zinc 129 Vitamin E + Vitamin A + Vitamin C + Selenium 130 Vitamin E + Vitamin A + Vitamin C + Biotin 131 Vitamin E + Vitamin A + Vitamin C + Folic Acid + Niacinamide 132 Vitamin E + Vitamin C + Beta-Carotene + Zinc 133 Vitamin C + Vitamin E + Biotin + Folic Acid 134 Vitamin C + Vitamin E + Beta-Carotene + Folic Acid 135 Vitamin C + Vitamin E + Beta-Carotene + Selenium 136 Vitamin E + Vitamin C + Beta-Carotene + Biotin 137 Vitamin D + Calcium + Omega-3 Fatty Acids + Vitamin K + Biotin 138 Vitamin D + Calcium + Omega-3 Fatty Acids + Vitamin K + Selenium 139 Vitamin D + Calcium + Omega-3 Fatty Acids + Vitamin K + Vitamin B12 140 Vitamin D + Calcium + Omega-3 Fatty Acids + Vitamin K + Vitamin B6 141 Vitamin D + Calcium + Omega-3 Fatty Acids + Vitamin K + Folate 142 Calcium + Vitamin D + Magnesium + Vitamin K + Omega-3 Fatty Acids 143 Calcium + Vitamin D + Magnesium + Vitamin K + Biotin 144 Calcium + Vitamin D + Magnesium + Vitamin K + Selenium 145 Calcium + Vitamin D + Magnesium + Vitamin K + Vitamin B12 146 Calcium + Vitamin D + Magnesium + Vitamin K + Folate 147 Calcium + Vitamin D + Vitamin K + Omega-3 Fatty Acids + Vitamin B6 148 Calcium + Vitamin D + Vitamin K + Omega-3 Fatty Acids + Vitamin B12 149 Calcium + Vitamin D + Vitamin K + Omega-3 Fatty Acids + Folic Acid 150 Calcium + Vitamin D + Vitamin K + Omega-3 Fatty Acids + Biotin 151 Calcium + Vitamin D + Vitamin K + Omega-3 Fatty Acids + Selenium 152 Vitamin A + Vitamin C + Vitamin E + Omega-3 Fatty Acids 153 Vitamin A + Vitamin C + Vitamin E + Omega-3 Fatty Acids + Zinc 154 Vitamin A + Vitamin C + Vitamin E + Omega-3 Fatty Acids + Biotin 155 Vitamin A + Vitamin C + Vitamin E + Omega-3 Fatty Acids + Selenium 156 Vitamin A + Vitamin C + Vitamin E + Omega-3 Fatty Acids + Vitamin B12

Drug Approval

27 Jul 2022

·endpts.com

Warning letter issued to New Jersey generics manufacturer over quality control issues

A generics manufacturer has received a warning letter from the FDA over several issues surrounding supervision and quality control. Bi-Coastal Pharma International’s drug manufacturing facility in Shrewsbury, New Jersey initially received a Form 483 earlier this year. But according to another letter dated June 30, the FDA has found some flagrant issues with the company’s responses. The letter initially stated that Bi-Coastal had failed to establish and follow written procedures around the handling of written and oral complaints for drug products. The FDA found that the company had not investigated a complaint about an adverse reaction after taking Chlordiazepoxide Hydrochloride (HCl) and Clidinium Bromide (Br), 5 mg/2.5 mg, which was discovered and distributed by the company. No investigation was initiated to evaluate the manufacturing and packaging of Chlordiazepoxide HCl and Clidinium Br, according to the letter. In addition, the FDA said Bi-Coastal didn’t attempt to obtain samples of the drug or more information from the complainant. Bi-Coastal said that its CMO was no longer in business and was unable to share the complaint with the CMO for further investigation. However, the FDA argues that as the product owner, Bi-Coastal is still responsible for ensuring control over outsourced activities. While the company said it would revise the process for handling complaints, the FDA found the response inadequate. Regulators also accused Bi-Coastal of failing to write down and follow procedures. No details of its interim controls were supplied to the FDA, or an evaluation of its agreements with the CMOs. The FDA also found that the QA manager lacked experience and training in quality assurance and the sciences, despite being responsible for overseeing CMOs and batch release. The manager was also “unaware of GMP stability testing and process validation requirements for drug products manufactured by CMOs.” In response, Bi-Coastal said its vice president and general manager will help ensure proper adherence to procedures while it finds a new manager. “This response is inadequate. You failed to provide evidence showing this individual is qualified to provide oversight of CGMP activities. In addition, you have not provided details as to how you will ensure the new quality assurance manager will have the appropriate combination of training, education, and experience to perform the job adequately,” the letter said. The company had 15 days from June 30 to respond to the FDA to fix these issues. If the issues remain unaddressed, the FDA may withhold the issuance of export certificates, or the approval of new applications or supplements until the company complies.

Generic Drug

100 Deals associated with Chlordiazepoxide

External Link

KEGG	Wiki	ATC	Drug Bank
D00267	Chlordiazepoxide	N05BA02	DB00475

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Epilepsy	China	Hubei Huazhong Pharmaceutical Co. Ltd.	01 Jan 1981
Sleep Initiation and Maintenance Disorders	China	Hubei Huazhong Pharmaceutical Co. Ltd.	01 Jan 1981
Mood Disorders	Japan	Takeda Pharmaceutical Co., Ltd.	01 Jun 1961
Muscle Spasticity	Japan	Maruishi Pharmaceutical Co., Ltd.	14 Mar 1961
Depressive Disorder	Japan	T’s Pharma Co., Ltd.	28 Feb 1961
Neurotic Disorders	Japan	T’s Pharma Co., Ltd.	28 Feb 1961
Anxiety Disorders	United States	Bausch Health Cos., Inc.	24 Feb 1960

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