Latest News: Gene Therapy for Cholesterol: Initial Test Results CheerUS Biotech Regeneron to launch Global Capability Centre in HyderabadPopped the Pill, Paid the Price to Potentially Fatal Skin SyndromeFormer Advisor to India’s Union Health Ministry gets Quite a Feather in his CapAlembic Pharma Secures USFDA Approval for Generic Synthroid TabletsSTF busts fake meds racket spread across 6 statesAll the Way from Teeth to Tee: Hole in OneZydus Lifesciences Q4FY26 net profit rises 9%Chemists strike on May 20: Reasons behind today’s all-India strikeAbbVie loses patent plea for Hep C drugGSK’s Calpol a well-known trademark: High Court3 arrested for allegedly posing as doctors using forged MBBS degreesCommissioner FDA reviews enforcement measuresKarnataka High Court stays FSSAI advisory banning use of Ashwagandha leaves in health supplementsRoche Pharma launches Tecentriq® SC, India’s first subcutaneous immunotherapy for lung cancerCDSCO tighten drug quality oversight as substandard and spurious medicine cases rise in five yearsPiramal Pharma Gets 3 USFDA Observations at US FacilityEli Lilly pauses Indian obesity awareness campaign after regulatory noticesKota: Uproar After 4 Women Die in Government Hospital; Relatives Refuse to Take BodiesICMR transfers three Indigenous Medical Technologies to Industry at National Technology Day 2026Will ‘Epidemic’ of Bridge Collapse in Bihar halt with new Minister in?Patient dies after oxygen supply stops in ambulanceIndiaAI, ICMR sign MoU to advance AI in healthcareIllegal drug manufacturing racket busted in Baddi areaUS FDA and Telangana DCA bolster global pharma safety at second regulatory forumNishant as Health Minister, Bihar is all set to witness a New Dawn of HealthcareSix Women Develop Serious Complications After C-SectionCracks Down on Pharma Biological Firm in Bagru; Labeling Violations, Unapproved Claims and Quality Lapses DetectedIndian Pharma Majors Plan to Invest in USEmcure Pharmaceuticals Q4 net profit rises 24% to ₹243.74 crFake Cancer Drug Racket: Delhi HC Grants Bail, Flags Gaps in ED ProbeA SSi Mantra fame Robotic Telesurgery Champion pulls off another Spectacular IntercontinentalNational Pharmaceutical Pricing Authority notifies retail price of 42 new drugsWorld’s First Malaria Treatment for Newborns and Young Infants Receives WHO PrequalificationFIR Lodged Against Pharmacist in Chandauli for Working Nearly 10 Years on Forged DocumentsLaughing all the Way to Health with Sir Ganga Ram HospitalSemaglutide generics ‘stimulating’ Obesity market growth, says Eli Lilly’s Patrik JonssonPak-made illegal cosmetics recovered from Itwari shopLicences of 20 medical stores suspended after inspectionsBain Capital sells nearly 1 pc stake in Emcure Pharma for Rs 289 croreSun Pharma to acquire U.S. firm Organon in $11.75 billion dealHP accounts for 47 inferior drugs in March alertCivil society group SAM calls for greater transparency involving clinical trialsDifferent packaging, typos expose fake Mounjaro racketTo Eat or not to Eat, if this Dilemma is ‘Eating’ you, ‘Eat’ this BookNCB Hyderabad raids illegal lab, seizes 69 kg of Alprazolam worth Rs 17.4 croreRajasthan Bans 7 Sub-Standard MedicinesONESOURCE’s partner receives USFDA tentative approval for Semaglutide InjectionAjanta Pharma gets USFDA Form 483 with five observations at Paithan plantObesity drug market to gain as Indians pop the pill and Chinese bring moreAurobindo Pharma Rs 800 Cr Buyback Opens Apr 23Boehringer Ingelheim launches AI centre for pharma research in LondonPharma exports rose 2% to over $31 billion in FY26 despite sharp decline in MarchCentre 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 rise
May 31, 2026
Latest News: Gene Therapy for Cholesterol: Initial Test Results CheerUS Biotech Regeneron to launch Global Capability Centre in HyderabadPopped the Pill, Paid the Price to Potentially Fatal Skin SyndromeFormer Advisor to India’s Union Health Ministry gets Quite a Feather in his CapAlembic Pharma Secures USFDA Approval for Generic Synthroid TabletsSTF busts fake meds racket spread across 6 statesAll the Way from Teeth to Tee: Hole in OneZydus Lifesciences Q4FY26 net profit rises 9%Chemists strike on May 20: Reasons behind today’s all-India strikeAbbVie loses patent plea for Hep C drugGSK’s Calpol a well-known trademark: High Court3 arrested for allegedly posing as doctors using forged MBBS degreesCommissioner FDA reviews enforcement measuresKarnataka High Court stays FSSAI advisory banning use of Ashwagandha leaves in health supplementsRoche Pharma launches Tecentriq® SC, India’s first subcutaneous immunotherapy for lung cancerCDSCO tighten drug quality oversight as substandard and spurious medicine cases rise in five yearsPiramal Pharma Gets 3 USFDA Observations at US FacilityEli Lilly pauses Indian obesity awareness campaign after regulatory noticesKota: Uproar After 4 Women Die in Government Hospital; Relatives Refuse to Take BodiesICMR transfers three Indigenous Medical Technologies to Industry at National Technology Day 2026Will ‘Epidemic’ of Bridge Collapse in Bihar halt with new Minister in?Patient dies after oxygen supply stops in ambulanceIndiaAI, ICMR sign MoU to advance AI in healthcareIllegal drug manufacturing racket busted in Baddi areaUS FDA and Telangana DCA bolster global pharma safety at second regulatory forumNishant as Health Minister, Bihar is all set to witness a New Dawn of HealthcareSix Women Develop Serious Complications After C-SectionCracks Down on Pharma Biological Firm in Bagru; Labeling Violations, Unapproved Claims and Quality Lapses DetectedIndian Pharma Majors Plan to Invest in USEmcure Pharmaceuticals Q4 net profit rises 24% to ₹243.74 crFake Cancer Drug Racket: Delhi HC Grants Bail, Flags Gaps in ED ProbeA SSi Mantra fame Robotic Telesurgery Champion pulls off another Spectacular IntercontinentalNational Pharmaceutical Pricing Authority notifies retail price of 42 new drugsWorld’s First Malaria Treatment for Newborns and Young Infants Receives WHO PrequalificationFIR Lodged Against Pharmacist in Chandauli for Working Nearly 10 Years on Forged DocumentsLaughing all the Way to Health with Sir Ganga Ram HospitalSemaglutide generics ‘stimulating’ Obesity market growth, says Eli Lilly’s Patrik JonssonPak-made illegal cosmetics recovered from Itwari shopLicences of 20 medical stores suspended after inspectionsBain Capital sells nearly 1 pc stake in Emcure Pharma for Rs 289 croreSun Pharma to acquire U.S. firm Organon in $11.75 billion dealHP accounts for 47 inferior drugs in March alertCivil society group SAM calls for greater transparency involving clinical trialsDifferent packaging, typos expose fake Mounjaro racketTo Eat or not to Eat, if this Dilemma is ‘Eating’ you, ‘Eat’ this BookNCB Hyderabad raids illegal lab, seizes 69 kg of Alprazolam worth Rs 17.4 croreRajasthan Bans 7 Sub-Standard MedicinesONESOURCE’s partner receives USFDA tentative approval for Semaglutide InjectionAjanta Pharma gets USFDA Form 483 with five observations at Paithan plantObesity drug market to gain as Indians pop the pill and Chinese bring moreAurobindo Pharma Rs 800 Cr Buyback Opens Apr 23Boehringer Ingelheim launches AI centre for pharma research in LondonPharma exports rose 2% to over $31 billion in FY26 despite sharp decline in MarchCentre 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 rise
May 31, 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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