Latest News: Centre Urges States To Enforce Clinical Establishments Act & Standardise Hospital RatesPiramal, Ajinomoto team on ADC development and manufacturingAurobindo Pharma Gets USFDA Nod for Glycerol LiquidCancer cure must not be hostage to Big PharmaGLP-1 drugs emerge as a new option for Indian women bat­tling PCOSAurobindo Pharma gains after receving USFDA nod for Glycerol Phenylbutyrate Oral LiquidLegal Loopholes Stall Crackdown On Interstate Fake Drug Rackets In IndiaPatna HC Rules Phenothiazine & Promethazine Not Narcotic Or Psychotropic Substances Under NDPS ActCOMT Inhibitors May Fuel Gut Bacteria That Degrade Levodopa In Parkinson’s PatientsDelhi Crime Branch Seizes Huge Stock Of Expired Baby Food, Cosmetics; One ArrestedFDA Releases Draft Guidance To Validate Non-Animal Testing Methods (NAMs) In Drug DevelopmentIPC releases draft NFI-2026 to promote rational use of medicinesMoonshot, SS Innovations displayed Battle Readiness for Monumental Goals in Robotic SurgeryUS market to dent India pharma earnings even as domestic growth remains firmBiocon Pharma receives USFDA approval for Dapagliflozin Tablets, 5 mg and 10 mgHealthcare, pharma sector to create 2-2.5 million new jobs by 2030Over 45% eye infection bacteria drug-resistant, study flags AMR threatLokayukta Police Launch Multi-City Raids on ADC; Rs 3.37 Crore in Disproportionate Assets Unearthed Across KarnatakaAlembic Pharma Gets USFDA Nod for DapagliflozinOn World Health Day ‘CAHO Na Patient Se Pyaar Hai’Supreme Court willing to understand Angst of Doctors regarding Consumer Protection ActAurobindo Pharma Board approves ₹800 cr share buyback planThree held for cheating SCB Hospital patients on promise of arranging bloodNATHEALTH resolves to evolve to fit The Bill of Viksit BharatCancer drug makers seek 50% price hike as platinum surge hits production viabilityCDRI’s new research hub in Lucknow to facilitate innovation in drug discovery & developmentDelhi Police busts racket diverting govt-supplied medicines for private sale; 3 heldNiti Aayog & DPIIT Decriminalize Med Device Penalties for Ease of BusinessLaser rescued an Imperiled Food Pipe in Sir Ganga Ram HospitalCentre gives custom cushion to supply strained Pharma, MedTech manufacturersDelhi man arrested for running online racket selling counterfeit Ayurvedic productsCustoms Duty Exemption on Petrochemicals, AiMeD welcomes but Dil ‘Mange More’Sir Ganga Ram Hospital Launches Dialysis Center in Gurgaon for advanced care3-month relief: Final call for 10,000 pharmacists to renew registrationMarksans Pharma gets USFDA nod for generic Benzonatate capsulesGreatest Defender of Consumer Rights doesn’t like Sound of Patient as ‘GRAHAK’Roche launches the cobas MPX-E assay, a new 4-in-1 donor screening testHaryana Mandates Real-Time Medicine Tracking In Govt HospitalsParliamentary Panel Recommends Decentralisation Of Approval Of All Medical DevicesDiabetic drug metformin found to act on brainHetero debuts semaglutide generic in emerging marketsLB Pharma Begins Pivotal Phase 3 Schizophrenia TrialCheck manufacturing, sale of 26 unapproved drugs, central regulator tells state authorityStem cell therapy for autism illegal: NMC advisoryIndia’s Essential Medicines Prices To Increase Marginally From 1 April Under Annual Pricing FrameworkDelhi HC Asks Dr Reddy’s To Halt Olymviq Sales; Flags Similarity With Novo Nordisk’s OzempicNPPA allows 0.64% hike in MRP of essential drugs in line with WPI riseGovt Outlines AYUSH Heavy Metal Monitoring Steps In Rajya SabhaRegulation Of Hair Transplant And Cosmetic Clinics Under The Purview Of States, No Plans To Create A Central Database Or Registry: Govt In RS24-year-old woman dies during surgery; Five UP doctors booked for negligenceExtortion, Fake Medicines: The Fall Of Surat’s Yoga GuruTaisho-controlled pharma giant DHG posts 9.4% net profit surge in 2025Ship of Domestic Medical Device Industry flounders, thanks to Israel-Iran WarDCGI Cracks Down On 90 Unapproved Fixed-Dose Combinations: Cough Syrups, Vitamins, Diabetes Drugs Among Those Flagged For Sale Without Central ApprovalIndia’s drug body flags 90 unapproved FDC medicines, states told to take actionIndia advancing as a global hub of affordable, quality healthcare solutions: Dr Jitendra SinghUnapproved drops for dry eyes pose risks: GovtSemaglutide Patent Expires: Will Diabetes, Weight-Loss Treatment Become More Accessible For Patients?Inaugural Conference of ‘Critical Nephrology Society of India’ (CNSI) puts Best Foot ForwardGovt highlights multi-layer framework to curb misleading advertisementsMajor breakhthrough: Sonbhadra cops nab codeine syrup racket handler in BengalStudy finds rising resistance to a last-resort antibiotic in AfricaPatna: Over 20,000 Banned Injections Seized in Ramkrishna Nagar Area, One ArrestedPharma Company Bus Overturns in Miyapur, 10 Employees Injured, Probe UnderwayIndia regulator asks states to implement uniform drug licensing norms to end quality gapsSale of fake obesity drugs driven by high prices, weight-loss desire prompts health concernCDSCO Has Approved 3 Drugs For Weight Management: Govt To Rajya SabhaNo spurious drugs were detected in the state during the 2024–25 financial year and so far in 2025–26: CM Manik Saha in AssemblyChirag Paswan says India working with global bodies on nutraceutical regulationsPeanut Stuck in the Airway of a Child ended up as EmergencyRaj HC quashes license cancellation of medical agency for RGHS irregularitiesAakash Healthcare registers 72 % Rise in Vaccination Volumes Post- CovidOfficials’ Apathy Allows Quackery To Flourish: Delhi’s ‘Salman Bhai’ Runs Paid ‘Herbal Cure’ Camp For Incurable Alopecia In MughalsaraiDepartment Of Commerce Organizes Chintan Shivir To Strengthen India’s Medical Devices Export EcosystemDomestic MedTech gets shot in the arm with First Fund launchedMinor Girl Hospitalised After Allegedly Consuming Cough Syrup In RaebareliSupreme Court declines plea to make nucleic acid tests compulsory at blood banksJaipur: Fraudster Arun Kumar Arrested for Extorting Medical Store Owners by Posing as Drug InspectorIndia’s Medical Devices Sector Logs 4,108 Licensed Manufacturers and ₹20,658 Crore FDI Inflows Since 2018Abbott introduces its most advanced drug eluting stent XIENCE Skypoint™ in IndiaTop 30 pharma companies post 12% revenue growth in first nine monthsIndia Cracks Down On Ads For Weight-Loss Drugs Like GLP-1 In New AdvisoryLudhiana police seize 56 kg ganja; courier warehouse under scannerAsterDMHealthcare-QCIL Merger mirrors Overwhelming Trust in LeadershipDCGI asks drugmakers to stop GLP-1 obesity awareness ad campaignsBeware- Glaucoma might steal Your Eyesight Unawares!Telangana DCA launches SMS alert system to notify NSQ drugsCentre of Excellence in Nutraceuticals inaugurated by the Hon’ble Chief Minister of KeralaATS Busts Drug Export Racket: 22 Kg Etomidate Seized, Two Arrested Including NikunjIran War Pushes Up Prices Of Raw Material In Pharma Industries: Will Vitamins, Antibiotics Be Costlier?Maharashtra, Gujarat & Uttarakhand lead in action against misleading adsSakeena Itoo reviews performance, functioning of JKMSCLDr Arun Prasad gets Recognition in London for Global ImpactKarnataka State Information Commission slaps ₹1 lakh penalty on BDA official for failing to provide informationNSQ reporting nearly doubles in 2025, buoyed by greater state participationTwo Gyms In Firozabad Raided, Seize 20 Mephentermine Injections Amid Health ConcernsDelhi Drugs Control Department Seizes Insulin Stock Worth Rs 20.06 LakhKerala Health Department Has Launched The MeHEALTH AppWar Could Affect Up To ₹5,000 Crore Of Pharma Exports And Disrupt Supply ChainsIndian National Sentenced In Counterfeit Cancer Drug Trafficking Case
April 21, 2026
Latest News: Centre Urges States To Enforce Clinical Establishments Act & Standardise Hospital RatesPiramal, Ajinomoto team on ADC development and manufacturingAurobindo Pharma Gets USFDA Nod for Glycerol LiquidCancer cure must not be hostage to Big PharmaGLP-1 drugs emerge as a new option for Indian women bat­tling PCOSAurobindo Pharma gains after receving USFDA nod for Glycerol Phenylbutyrate Oral LiquidLegal Loopholes Stall Crackdown On Interstate Fake Drug Rackets In IndiaPatna HC Rules Phenothiazine & Promethazine Not Narcotic Or Psychotropic Substances Under NDPS ActCOMT Inhibitors May Fuel Gut Bacteria That Degrade Levodopa In Parkinson’s PatientsDelhi Crime Branch Seizes Huge Stock Of Expired Baby Food, Cosmetics; One ArrestedFDA Releases Draft Guidance To Validate Non-Animal Testing Methods (NAMs) In Drug DevelopmentIPC releases draft NFI-2026 to promote rational use of medicinesMoonshot, SS Innovations displayed Battle Readiness for Monumental Goals in Robotic SurgeryUS market to dent India pharma earnings even as domestic growth remains firmBiocon Pharma receives USFDA approval for Dapagliflozin Tablets, 5 mg and 10 mgHealthcare, pharma sector to create 2-2.5 million new jobs by 2030Over 45% eye infection bacteria drug-resistant, study flags AMR threatLokayukta Police Launch Multi-City Raids on ADC; Rs 3.37 Crore in Disproportionate Assets Unearthed Across KarnatakaAlembic Pharma Gets USFDA Nod for DapagliflozinOn World Health Day ‘CAHO Na Patient Se Pyaar Hai’Supreme Court willing to understand Angst of Doctors regarding Consumer Protection ActAurobindo Pharma Board approves ₹800 cr share buyback planThree held for cheating SCB Hospital patients on promise of arranging bloodNATHEALTH resolves to evolve to fit The Bill of Viksit BharatCancer drug makers seek 50% price hike as platinum surge hits production viabilityCDRI’s new research hub in Lucknow to facilitate innovation in drug discovery & developmentDelhi Police busts racket diverting govt-supplied medicines for private sale; 3 heldNiti Aayog & DPIIT Decriminalize Med Device Penalties for Ease of BusinessLaser rescued an Imperiled Food Pipe in Sir Ganga Ram HospitalCentre gives custom cushion to supply strained Pharma, MedTech manufacturersDelhi man arrested for running online racket selling counterfeit Ayurvedic productsCustoms Duty Exemption on Petrochemicals, AiMeD welcomes but Dil ‘Mange More’Sir Ganga Ram Hospital Launches Dialysis Center in Gurgaon for advanced care3-month relief: Final call for 10,000 pharmacists to renew registrationMarksans Pharma gets USFDA nod for generic Benzonatate capsulesGreatest Defender of Consumer Rights doesn’t like Sound of Patient as ‘GRAHAK’Roche launches the cobas MPX-E assay, a new 4-in-1 donor screening testHaryana Mandates Real-Time Medicine Tracking In Govt HospitalsParliamentary Panel Recommends Decentralisation Of Approval Of All Medical DevicesDiabetic drug metformin found to act on brainHetero debuts semaglutide generic in emerging marketsLB Pharma Begins Pivotal Phase 3 Schizophrenia TrialCheck manufacturing, sale of 26 unapproved drugs, central regulator tells state authorityStem cell therapy for autism illegal: NMC advisoryIndia’s Essential Medicines Prices To Increase Marginally From 1 April Under Annual Pricing FrameworkDelhi HC Asks Dr Reddy’s To Halt Olymviq Sales; Flags Similarity With Novo Nordisk’s OzempicNPPA allows 0.64% hike in MRP of essential drugs in line with WPI riseGovt Outlines AYUSH Heavy Metal Monitoring Steps In Rajya SabhaRegulation Of Hair Transplant And Cosmetic Clinics Under The Purview Of States, No Plans To Create A Central Database Or Registry: Govt In RS24-year-old woman dies during surgery; Five UP doctors booked for negligenceExtortion, Fake Medicines: The Fall Of Surat’s Yoga GuruTaisho-controlled pharma giant DHG posts 9.4% net profit surge in 2025Ship of Domestic Medical Device Industry flounders, thanks to Israel-Iran WarDCGI Cracks Down On 90 Unapproved Fixed-Dose Combinations: Cough Syrups, Vitamins, Diabetes Drugs Among Those Flagged For Sale Without Central ApprovalIndia’s drug body flags 90 unapproved FDC medicines, states told to take actionIndia advancing as a global hub of affordable, quality healthcare solutions: Dr Jitendra SinghUnapproved drops for dry eyes pose risks: GovtSemaglutide Patent Expires: Will Diabetes, Weight-Loss Treatment Become More Accessible For Patients?Inaugural Conference of ‘Critical Nephrology Society of India’ (CNSI) puts Best Foot ForwardGovt highlights multi-layer framework to curb misleading advertisementsMajor breakhthrough: Sonbhadra cops nab codeine syrup racket handler in BengalStudy finds rising resistance to a last-resort antibiotic in AfricaPatna: Over 20,000 Banned Injections Seized in Ramkrishna Nagar Area, One ArrestedPharma Company Bus Overturns in Miyapur, 10 Employees Injured, Probe UnderwayIndia regulator asks states to implement uniform drug licensing norms to end quality gapsSale of fake obesity drugs driven by high prices, weight-loss desire prompts health concernCDSCO Has Approved 3 Drugs For Weight Management: Govt To Rajya SabhaNo spurious drugs were detected in the state during the 2024–25 financial year and so far in 2025–26: CM Manik Saha in AssemblyChirag Paswan says India working with global bodies on nutraceutical regulationsPeanut Stuck in the Airway of a Child ended up as EmergencyRaj HC quashes license cancellation of medical agency for RGHS irregularitiesAakash Healthcare registers 72 % Rise in Vaccination Volumes Post- CovidOfficials’ Apathy Allows Quackery To Flourish: Delhi’s ‘Salman Bhai’ Runs Paid ‘Herbal Cure’ Camp For Incurable Alopecia In MughalsaraiDepartment Of Commerce Organizes Chintan Shivir To Strengthen India’s Medical Devices Export EcosystemDomestic MedTech gets shot in the arm with First Fund launchedMinor Girl Hospitalised After Allegedly Consuming Cough Syrup In RaebareliSupreme Court declines plea to make nucleic acid tests compulsory at blood banksJaipur: Fraudster Arun Kumar Arrested for Extorting Medical Store Owners by Posing as Drug InspectorIndia’s Medical Devices Sector Logs 4,108 Licensed Manufacturers and ₹20,658 Crore FDI Inflows Since 2018Abbott introduces its most advanced drug eluting stent XIENCE Skypoint™ in IndiaTop 30 pharma companies post 12% revenue growth in first nine monthsIndia Cracks Down On Ads For Weight-Loss Drugs Like GLP-1 In New AdvisoryLudhiana police seize 56 kg ganja; courier warehouse under scannerAsterDMHealthcare-QCIL Merger mirrors Overwhelming Trust in LeadershipDCGI asks drugmakers to stop GLP-1 obesity awareness ad campaignsBeware- Glaucoma might steal Your Eyesight Unawares!Telangana DCA launches SMS alert system to notify NSQ drugsCentre of Excellence in Nutraceuticals inaugurated by the Hon’ble Chief Minister of KeralaATS Busts Drug Export Racket: 22 Kg Etomidate Seized, Two Arrested Including NikunjIran War Pushes Up Prices Of Raw Material In Pharma Industries: Will Vitamins, Antibiotics Be Costlier?Maharashtra, Gujarat & Uttarakhand lead in action against misleading adsSakeena Itoo reviews performance, functioning of JKMSCLDr Arun Prasad gets Recognition in London for Global ImpactKarnataka State Information Commission slaps ₹1 lakh penalty on BDA official for failing to provide informationNSQ reporting nearly doubles in 2025, buoyed by greater state participationTwo Gyms In Firozabad Raided, Seize 20 Mephentermine Injections Amid Health ConcernsDelhi Drugs Control Department Seizes Insulin Stock Worth Rs 20.06 LakhKerala Health Department Has Launched The MeHEALTH AppWar Could Affect Up To ₹5,000 Crore Of Pharma Exports And Disrupt Supply ChainsIndian National Sentenced In Counterfeit Cancer Drug Trafficking Case
April 21, 2026

Alembic Pharma gets USFDA nod for insomnia treatment drug

New Delhi: Drug firm Alembic Pharmaceuticals has received approval from the US health regulator for Temazepam capsules, used for treatment of insomnia.

The company has got approval from the US Food and Drug Administration (USFDA) to market the drug in the strength of 7.5mg, 15mg, 22.5mg and 40mg, Alembic Pharmaceuticals said in a BSE filing.

The approved abbreviated new drug application (ANDA) is the therapeutic equivalent to the reference listed drug product (RLD) Restoril Capsules.

Quoting IQVIA sales data, the company said, Temazepam capsules 7.5mg, 15mg, 22.5mg and 40mg had an estimated market size of USD 48 million for 12 months, ending December 2017.

The company’s stock was trading at Rs 567 apiece, up 1.33 per cent, on the BSE.

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