[Translation] A randomized, open-label, single-dose, two-sequence, two-period, two-crossover bioequivalence study of piracetam tablets (0.4g) in healthy Chinese participants under postprandial dosing conditions.

主要研究目的：按有关生物等效性试验的规定，选择UCB PHARMA S.A.（优时比制药公司）为持证商的吡拉西坦片（商品名：Nootropyl，规格：0.8g）为参比制剂，对石药集团欧意药业有限公司生产并提供的受试制剂吡拉西坦片（规格：0.4g）进行餐后给药人体生物等效性试验，比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内，评价两种制剂在餐后给药条件下的生物等效性。次要研究目的：观察健康试验参与者口服受试制剂吡拉西坦片（规格：0.4g）和参比制剂吡拉西坦片（商品名：Nootropyl，规格：0.8g）的安全性。

[Translation]

Primary Objective: In accordance with relevant bioequivalence testing regulations, piracetam tablets (trade name: Nootropyl, strength: 0.8g) manufactured by UCB PHARMA S.A. (UCB Pharmaceuticals Inc.) were selected as the reference formulation. A postprandial administration bioequivalence study was conducted on the test formulation piracetam tablets (strength: 0.4g) manufactured and supplied by CSPC Ouyi Pharmaceutical Co., Ltd. The study compared the absorption rate and extent of the drug in the test formulation with those in the reference formulation to determine if the differences were within acceptable limits, evaluating the bioequivalence of the two formulations under postprandial administration conditions. Secondary Objective: To observe the safety of oral administration of the test formulation piracetam tablets (strength: 0.4g) and the reference formulation piracetam tablets (trade name: Nootropyl, strength: 0.8g) to healthy participants.

Start Date02 Mar 2026

Sponsor / Collaborator

CSPC Ouyi Pharmaceutical Co., Ltd.

CTR20255218

/ CompletedNot Applicable

吡拉西坦片（0.4g）在中国健康试验参与者中空腹给药条件下随机、开放、单剂量、两序列、两周期、双交叉生物等效性试验

[Translation] A randomized, open-label, single-dose, two-sequence, two-period, double-crossover bioequivalence study of piracetam tablets (0.4g) in healthy Chinese participants under fasting administration conditions.

主要研究目的：按有关生物等效性试验的规定，选择UCB PHARMA S.A.（优时比制药公司）为持证商的吡拉西坦片（商品名：Nootropyl，规格：0.8g）为参比制剂，对石药集团欧意药业有限公司生产并提供的受试制剂吡拉西坦片（规格：0.4g）进行空腹给药人体生物等效性试验，比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内，评价两种制剂在空腹给药条件下的生物等效性。次要研究目的：观察健康试验参与者口服受试制剂吡拉西坦片（规格：0.4g）和参比制剂吡拉西坦片（商品名：Nootropyl，规格：0.8g）的安全性。

[Translation]

Primary objective: In accordance with relevant bioequivalence testing regulations, piracetam tablets (trade name: Nootropyl, strength: 0.8g) manufactured by UCB PHARMA S.A. (UCB Pharmaceuticals Inc.) were selected as the reference formulation. A fasting-administered human bioequivalence study was conducted on the test formulation piracetam tablets (strength: 0.4g) manufactured and supplied by CSPC Ouyi Pharmaceutical Co., Ltd. The study compared the absorption rate and extent of the drug in the test formulation with those in the reference formulation to determine if the differences were within acceptable limits, thus evaluating the bioequivalence of the two formulations under fasting administration conditions. Secondary objective: To observe the safety of oral administration of the test formulation piracetam tablets (strength: 0.4g) and the reference formulation piracetam tablets (trade name: Nootropyl, strength: 0.8g) to healthy participants.

Start Date12 Jan 2026

Sponsor / Collaborator

CSPC Ouyi Pharmaceutical Co., Ltd.

CTR20252470

/ CompletedNot Applicable

吡拉西坦片（0.8g）在中国健康受试者中空腹和餐后给药条件下随机、开放、单剂量、两序列、两周期、双交叉生物等效性试验

[Translation] A randomized, open-label, single-dose, two-sequence, two-period, double-crossover bioequivalence study of piracetam tablets (0.8 g) in Chinese healthy subjects under fasting and fed conditions

主要研究目的：按有关生物等效性试验的规定，选择UCB PHARMA S.A.为持证商的吡拉西坦片（商品名：Nootropyl；规格：0.8g）为参比制剂，对乐声药业石家庄有限公司生产的受试制剂吡拉西坦片（规格：0.8g）进行空腹和餐后给药条件下的人体生物等效性试验，比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内，评价两种制剂在空腹和餐后给药条件下的生物等效性。次要研究目的：观察健康受试者口服受试制剂吡拉西坦片（规格：0.8g）和参比制剂吡拉西坦片（商品名：Nootropyl；规格：0.8g）的安全性。

[Translation]

Main research purpose: According to the relevant provisions of bioequivalence test, Piracetam Tablets (trade name: Nootropyl; specification: 0.8g) of UCB PHARMA S.A. as the licensee was selected as the reference preparation, and the human bioequivalence test of the test preparation Piracetam Tablets (specification: 0.8g) produced by Lesheng Pharmaceutical Shijiazhuang Co., Ltd. was conducted under fasting and postprandial administration conditions to compare whether the absorption rate and degree of the drug in the test preparation were within the acceptable range with the reference preparation, and to evaluate the bioequivalence of the two preparations under fasting and postprandial administration conditions. Secondary research purpose: To observe the safety of oral administration of the test preparation Piracetam Tablets (specification: 0.8g) and the reference preparation Piracetam Tablets (trade name: Nootropyl; specification: 0.8g) in healthy subjects.

Start Date17 Jul 2025

Sponsor / Collaborator

Hebei Medical University Pharmaceutical Factory

100 Clinical Results associated with Piracetam

100 Translational Medicine associated with Piracetam

100 Patents (Medical) associated with Piracetam

1,926

Literatures (Medical) associated with Piracetam

01 Jun 2026·MOLECULAR NUTRITION & FOOD RESEARCH

Shrimp Oil Enhances Cognition by Suppressing Neuroinflammation in a Chronic Cerebral Hypoperfusion Rat Model

Article

Author: Tocharus, Jiraporn ; Wongpun, Jittiporn ; Buamard, Natchaphol ; Benjakul, Soottawat ; Roytrakul, Sittiruk ; Sengking, Jirakhamon ; Wicha, Piyawadee ; Tocharus, Chainarong ; Charoenlappanit, Sawanya

ABSTRACT:

Vascular dementia (VaD) is the second most common age‐related condition worldwide in aging populations. Neuroinflammation is a key contributor to the pathological process of VaD. Shrimp oil is a by‐product of shrimp processing that is rich in astaxanthin and lipids. This study aimed to investigate the effect of shrimp oil on neuroinflammation and its underlying mechanisms in chronic cerebral hypoperfusion (CCH) rats. Male Wistar rats subjected to bilateral common carotid artery occlusion received oral shrimp oil or piracetam once daily for 5 weeks. Shrimp oil significantly improved muscle coordination and enhanced reference spatial memory. Proteomic profiling showed that shrimp oil mitigated the CCH‐induced proteomic signature, specifically reprogramming protein clusters related to neuroinflammation and AMPK–SIRT1 signaling. Western blot analysis indicated that shrimp oil reduced the expression of neuroinflammation‐associated proteins, including TLR4 and NF‐κB, and suppressed M1 microglial activation, NLRP3 inflammasome activation, and pyroptosis. These effects were accompanied by increased expression of myelination‐related proteins, including oligodendrocyte transcription factor 1 (OLIG1) and myelin basic protein (MBP). Inflammation was more likely suppressed by upregulated AMPK and sirtuin‐1 (SIRT1) pathway, but not related to PPARγ signaling. These findings suggest that shrimp oil is a promising candidate for the treatment of VaD.

12 May 2026·Cureus Journal of Medical Science

Longitudinal Outcomes of Oral Glutamatergic Augmentation in Trauma-Related Dissociation: A Six-Month Case Study

Article

Author: Cheung, Ngo

Trauma-related dissociation can present with derealisation, depersonalisation, abrupt lapses in awareness, memory gaps, and fugue-like states, and it may be difficult to treat with standard approaches alone. Glutamatergic interventions have been proposed as neuroplasticity-focused strategies because N-methyl-D-aspartate (NMDA) receptor antagonism and downstream alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA)-linked signalling may influence synaptic plasticity. A 25-year-old woman with documented complicated grief related to her paternal grandfather's sudden death, longstanding derealisation, recurrent blank-outs, and fugue-like episodes presented with moderate depressive symptoms and moderate-to-severe anxiety. Over approximately seven months of documented outpatient psychiatric follow-up from 14 October 2025 to 4 May 2026, she was treated in an outpatient setting with an oral regimen consisting of dextromethorphan 30-60 mg/day, fluoxetine 10 mg/day, piracetam 600-1200 mg/day, and low-dose antipsychotic medication, with later medication adjustments according to tolerability and clinical response. Depressive symptoms improved gradually from moderate to mild severity. The most notable clinical change was the complete and sustained resolution of dissociative blank-outs and fugue-like states, accompanied by improved work performance, fewer unnoticed errors, and better self-monitoring. Generalized anxiety and relationship-triggered emotional reactivity improved only partially. Morning tiredness was reported early in treatment; however, the clinical record did not specify enough information to attribute this definitively to medication timing. This case suggests that oral NMDA-AMPA modulation may support progressive recovery of cognitive integration and functional capacity in trauma-related dissociation, while residual anxiety and interpersonal reactivity may require additional psychotherapeutic or targeted approaches. The case adds hypothesis-generating longitudinal support for low-cost glutamatergic augmentation in routine outpatient practice.

10 May 2026·Cureus Journal of Medical Science

Longitudinal Management of Post-traumatic Brain Injury Bipolar-Spectrum Disorder With Low-Dose Oral Glutamatergic Augmentation: Extended Follow-Up Revealing Induction, Overshoot, Stabilization, and Transition to PRN Maintenance

Article

Author: Cheung, Ngo

Bipolar-spectrum illness emerging after traumatic brain injury (TBI) can be difficult to treat and may present with mixed or agitated depressive features that appear sensitive to glutamatergic modulation. In post-TBI cases, diagnostic certainty is often limited because irritability, impulsivity, sleep disturbance, affective lability, and cognitive change may overlap with frontal-limbic injury syndromes. This case is, therefore, framed as probable bipolar-spectrum disorder secondary to TBI rather than definitive idiopathic bipolar disorder. The Cheung Glutamatergic Regimen (CGR)--low-dose dextromethorphan with CYP2D6 inhibition plus piracetam--is used here only as a shorthand for an open-source, free-to-use, non-proprietary combination of off-patent components, not as a branded product. This report describes a woman in her mid-thirties with right frontal atrophy after a 2009 subdural hematoma who later developed probable bipolar-spectrum illness. On 21 October 2025, she presented with severe depressive relapse, insomnia, persistent rumination, irritability, and hypnagogic phenomena, with a Patient Health Questionnaire-9 (PHQ-9) score of 22. After partial improvement on valproate, risperidone, and Deanxit, dextromethorphan 30 mg nightly and piracetam 600 mg nightly were added on 5 November 2025. Within weeks, rumination decreased and mental flexibility improved, but transient mild hypomanic or frontal-disinhibition-like symptoms emerged, especially inappropriate laughter with a moria-like quality. She self-reduced dextromethorphan to 22.5 mg, piracetam was increased, and euthymia returned. Over the next six months, PHQ-9 scores improved to 10-12 and Generalized Anxiety Disorder-7 (GAD-7) scores to 8-13, with functional gains including exercise and motorcycle riding lessons. Later medications included aripiprazole, paroxetine-controlled release, pregabalin, and low-dose quetiapine. By April 2026, dextromethorphan and piracetam were used as needed during stress-related or premenstrual dips. No further psychotic symptoms were reported, and later mild dissociative or cognitive complaints became manageable after dose adjustment. This single-patient course suggests a three-phase pattern: induction with a narrow therapeutic window and brief activation/overshoot, stabilization after titration, and later PRN maintenance. Dextromethorphan appeared temporally most linked to both clinical benefit and transient activation, while piracetam may have acted as a modulator. However, causal inference is limited by the uncontrolled design, early PHQ-9 improvement before CGR initiation, later polypharmacy, unmeasured pharmacokinetics, absence of standardized mania/cognitive measures, and incomplete PRN-frequency documentation. The case is also only hypothesis-generating in relation to transcriptomic findings implicating bipolar-specific plasticity-related biology. Low-dose oral glutamatergic augmentation may warrant study as a closely monitored induction and consolidation strategy in post-TBI bipolar-spectrum illness, but prospective controlled trials are needed before broader recommendations can be made.

News (Medical) associated with Piracetam

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

12 Mar 2019

·www.biospace.com

FDA Warning Letters: An Overview of 2019’s Letters So Far

The FDA issues Warning Letters to biopharma, medical device and food companies when they find that a manufacturer has significantly violated FDA regulations. As of March 4, the agency issued 45 Warning Letters this year. The U.S. Food and Drug Administration (FDA) issues Warning Letters to biopharma, medical device and food companies when they find that a manufacturer has significantly violated FDA regulations. As of March 4, the agency issued 45 Warning Letters this year. Some are related to food companies, while quite a few are related to “vaping” products. Here’s a look at this year’s Warning Letters aimed at biopharmaceutical companies. Lymol Medical Corporation. Although somewhat outside the view of BioSpace’s coverage, it is mentioned here because it involves contamination of Sterile Talc Powder, which is an issue that has plagued Johnson & Johnson in recent years. The FDA issued a letter to Lymol on Jan. 8 related to lead content in talc. Vitalab Pharmacy dba Vasco Rx. Vitalab was warned on Jan. 10 regarding “serious deficiencies in your practices for producing sterile drug products, which put patients at risk.” There appear to be issues with a laminar airflow hood design and poor aseptic technique on the part of technicians. Vipor Chemicals Private. A Warning Letter was sent on Jan. 29 citing Vipor, located in India, with “significant deviations from current good manufacturing practices (CGMP) for active pharmaceutical ingredients (API).” It also indicated one of the company’s suppliers, Basic Pharma Life Science Private (Ankleshwar, India) had been placed on FDA Import Alert 99-32 for refusing an FDA inspection on Oct. 10, 2017. Hangzhou Sunking Nonwovens Co. The FDA issued a Warning Letter on Jan. 29 to China’s Hangzhou over an August 2018 inspection, citing several significant violations of CGMP regulations for finished pharmaceuticals. New Era Naturals. Based in Durango, Colo., New Era received a Warning Letter after a March to April 2018 inspection, citing CGMP regulation violations for finished pharmaceuticals. In addition to not conforming to the CGMP regulations, the company’s “drug products are not listed with FDA as required by section 510(j) of the FD&C Act. Failure to properly list a drug product is prohibited and will render a drug misbranded.” Green Water. Based in Conifer, Colo., Green Water was cited after a June and July 2018 inspection of its manufacturing facility. They were warned about serious violations of the Federal Food, Drug, and Cosmetic Act, specifically over unapproved new and misbranded drugs and issues with labeling. Actavis Laboratories FL. This Davie, Fla.-based company was cited after a July 2018 FDA inspection for CGMP regulations for finished pharmaceuticals. There were issues with adequate written procedures, issues with tablet manufacturing validation, largely around a laser-drilling tablet manufacturing process. Akorn . The FDA issued a Warning Letter to this Lake Forest, Ill.-based company after an April and May 2018 inspection for CGMP violations. Some of the problems regarded microbial contamination of drug products and aseptic technique by employees. There were also issues related to contaminated materials in the company’s cleanroom. Blue Ridge Silver. Based in Blowing Rock, NC, Blue Ridge Silver was warned by the FDA over its Colloidal Silver Products, largely over false and misleading statements about the products on the company’s website and marketing materials. Peak Nootropics (aka Advanced Nootropics). The FDA issued a letter on Feb. 5 over false claims on its website. The agency stated, “Your products Adrafinil, Aniracetam, Bacopa Monnieri, L-Dopa, L-Theanine, Noopept, Oxiracetam, Phenibut, Phenylpiracetam, Piracetam, Pramiracetam, Rhodiola Rosea, and Uridine are not generally recognized as safe and effective for the above referenced uses and, therefore, these products are ‘new drugs’ under section 201(p) of the Act.” Emmbros Overseas Lifestyle PVT. This India-based company was also cited on Feb. 5 for false claims on its website and violations of the Act. DK Vitamins. Located in Palm Bay, Fla., DK Vitamins was yet another mail order company making false claims on its website and in marketing materials over some of its product. Other companies on the same day that were issued similar Warning Letters include Earth Turns, Sovereign Laboratories, Gold Crown Natural Products, Nutrition Coalition, Capris Associate/BR Naturals, Pure Nootropics, TEK Naturals, CanaRx Services (2/26/19) and John Gray’s Mars Venus. Triad Rx. This Alabama-based company was warned over a July 2017 inspection over problems in their sterile drug products practices. They were also cited for misleading or false statements in marketing materials and misbranded drug products McKesson . The FDA issued a Warning Letter on Feb. 7 over a corporate headquarters and distribution facility inspection in June and July 2018. The agency cited significant violations of verification requirements in the supply chain for prescription drugs, failure to respond to illegitimate product notifications, failure to quarantine and investigate suspected products, and a failure to keep appropriate records of the suspect products. United Pharmacy. Based in West Palm Beach, Fla., United Pharmacy was warned over issues with compounded drug products. Bella Pharmaceuticals received a similar warning on Feb. 11 as well. Proandre SL. Based in Barcelona, Spain, Proandre was warned over an FDA inspection in June 2018, noting violations of CGMP regulations. The warnings revolve around quality control issues for its batch production operations. Pure Source. Based in Doral, Fla., it received a Warning Letter from the FDA after a February and March 2018 inspection over CGMP violations. The primary citation is over failure to thoroughly investigate unexplained discrepancies or failures of a batch of its components, some of which were contaminated with bacteria. Vivet Pharmaceuticals. The FDA warned this Chester Springs, Penn.-based company over a June 2018 inspection, largely over CGMP violations. It was cited for quality control issues as well as its drug listing. ANDAPharm. Based in Fort Lauderdale, Fla., ANDAPharm received a Warning Letter on Feb. 28 for violations of CGMP regulations. They were primarily over failure to establish and follow adequate written procedures for cleaning and maintaining equipment, as well as problems related to failing to have a testing program to assess drug stability and other control systems.

100 Deals associated with Piracetam

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KEGG	Wiki	ATC	Drug Bank
D01914	Piracetam	N06BX03	DB09210

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Indication	Country/Location	Organization	Date
Epilepsy	Japan	CHEPLAPHARM Arzneimittel GmbH	22 Sep 1999
Memory Disorders	China	Dalian Tianyu Pharmaceutical Co.,Ltd.	01 Jan 1977

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Indication	Highest Phase	Country/Location	Organization	Date
Unverricht-Lundborg Syndrome	Preclinical	United States	Kalevala Therapeutics, Inc.	11 Jul 2026

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