Latest News: Probe report into maternal deaths sparks Kota rowCentre bans 16 Fixed-Dose Combination drugs over safety concernsMaha FDA seizes medicines worth Rs 9.09 lakh from Mumbai children’s hospital over alleged illegal saleCDSCO constitutes consultancy committee for advice on suo motu disclosureTelangana DCA busts illegal API stock, seizes drugs worth Rs 34LZenré Wellness, a New Genre of Mental Care, unveils in DelhiRaids On Many Hospitals Across Kerala In Organ Trafficking ProbeOver-the-counter sale of cough syrup barredFDA seals Bhiwandi-based cosmetic factory for misleading claims, fake addressYashoda Medicity’s AI-enabled E- ICU poised to make Quality Critical Care UniversalLicences no shield in NDPS cases: HC refuses bail in 1.37 crore tablets seizureNo cough syrups without a doctor’s prescription – New rules announcedCSIR-IIIM launches two-month certificate course On cGMP-compliant herbal drug manufacturingTwo nurses at AIIMS Bhopal booked for giving wrong injection to child cancer patient that caused his deathTelangana DCA unearths Rs 70.56-lakh excipient label-tampering scam‘Did patients come dancing?’ – Rajasthan minister’s remarks about kidney failure case spark rowPrice cap on 2 key cancer drugs increased by 50%Hospitals can’t force patients to buy medicines from their pharmacies: Maha FDAIIT Bhubaneswar researchers develop portable device for accurate arsenic detectionBribe of Rs 3 crore: Delhi Police inspector held, senior public servant under CBI scannerNo raids till further orders: Maharashtra tells Bombay HC in Patanjali labelling caseCrackdown on Illegal Sale of Mephentermine Sulphate Injections in Warangal GymsAjanta Pharma Promoter Sell 3% Stake Worth ₹1,024 Crore; Shares Trade HigherFDA cracks down on illegal drug trade, stock worth about ₹25 lakh seized from Pune and KolhapurICMR-NIN study links micronutrient deficiencies to higher dementia riskPvt nursing home sealed in Chatra after woman, unborn baby die30 docs from 9 states guilty of taking pharma company junket, no action yet by 6 state medical councilsScheme to build bulk drugs’ R&D, capacity in works, says Pharma secyDrug companies directed to step up vigil on adverse reactionsMaharashtra FDA seizes medical devices, gloves worth ₹2.17 cr in crackdown on irregularitiesAI-designed universal coronavirus vaccine passes first human trialKGMU prof suspended for forcing patients to buy meds from pvt storeWorld Record in Robotic Tele-Surgery takes Intercontinental Leap of 20,000 KmCDSCO receives 1,387 adverse drug reaction reports in nine months of 2025NGT issues notice to Himachal pharma unit over pollution, water diversion allegationsZydus Semaglutide approval: Delhi HC directs CDSCO to decide on patient safety concernsDGFT Fixes Six New Standard Input Output Norms (SIONs) for Pharmaceutical and Chemical ExportsNurse, another arrested in ASHA worker’s death at illegal hospital; main accused at largeKGMU to file FIR against 4 employees over Rs 2.5 crore medicine procurement irregularitiesHaryana Launches ‘Make in Haryana Industrial Policy’A new pancreatic cancer pill may be a game changer for patientsNPPA fixes prices of 30 drugs including Vitamin D3, calcium supplementsMaharashtra FDA seizes ₹73 lakh worth of medicines in crackdown on misleading health claims in adsIndustry asks NPPA to implement SOTS Scheme to resolve pending litigationsA Non- Smoker Smoking Hot Spouse needed for Actress Neetu ChandraGene 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 manufacturing
June 21, 2026
Latest News: Probe report into maternal deaths sparks Kota rowCentre bans 16 Fixed-Dose Combination drugs over safety concernsMaha FDA seizes medicines worth Rs 9.09 lakh from Mumbai children’s hospital over alleged illegal saleCDSCO constitutes consultancy committee for advice on suo motu disclosureTelangana DCA busts illegal API stock, seizes drugs worth Rs 34LZenré Wellness, a New Genre of Mental Care, unveils in DelhiRaids On Many Hospitals Across Kerala In Organ Trafficking ProbeOver-the-counter sale of cough syrup barredFDA seals Bhiwandi-based cosmetic factory for misleading claims, fake addressYashoda Medicity’s AI-enabled E- ICU poised to make Quality Critical Care UniversalLicences no shield in NDPS cases: HC refuses bail in 1.37 crore tablets seizureNo cough syrups without a doctor’s prescription – New rules announcedCSIR-IIIM launches two-month certificate course On cGMP-compliant herbal drug manufacturingTwo nurses at AIIMS Bhopal booked for giving wrong injection to child cancer patient that caused his deathTelangana DCA unearths Rs 70.56-lakh excipient label-tampering scam‘Did patients come dancing?’ – Rajasthan minister’s remarks about kidney failure case spark rowPrice cap on 2 key cancer drugs increased by 50%Hospitals can’t force patients to buy medicines from their pharmacies: Maha FDAIIT Bhubaneswar researchers develop portable device for accurate arsenic detectionBribe of Rs 3 crore: Delhi Police inspector held, senior public servant under CBI scannerNo raids till further orders: Maharashtra tells Bombay HC in Patanjali labelling caseCrackdown on Illegal Sale of Mephentermine Sulphate Injections in Warangal GymsAjanta Pharma Promoter Sell 3% Stake Worth ₹1,024 Crore; Shares Trade HigherFDA cracks down on illegal drug trade, stock worth about ₹25 lakh seized from Pune and KolhapurICMR-NIN study links micronutrient deficiencies to higher dementia riskPvt nursing home sealed in Chatra after woman, unborn baby die30 docs from 9 states guilty of taking pharma company junket, no action yet by 6 state medical councilsScheme to build bulk drugs’ R&D, capacity in works, says Pharma secyDrug companies directed to step up vigil on adverse reactionsMaharashtra FDA seizes medical devices, gloves worth ₹2.17 cr in crackdown on irregularitiesAI-designed universal coronavirus vaccine passes first human trialKGMU prof suspended for forcing patients to buy meds from pvt storeWorld Record in Robotic Tele-Surgery takes Intercontinental Leap of 20,000 KmCDSCO receives 1,387 adverse drug reaction reports in nine months of 2025NGT issues notice to Himachal pharma unit over pollution, water diversion allegationsZydus Semaglutide approval: Delhi HC directs CDSCO to decide on patient safety concernsDGFT Fixes Six New Standard Input Output Norms (SIONs) for Pharmaceutical and Chemical ExportsNurse, another arrested in ASHA worker’s death at illegal hospital; main accused at largeKGMU to file FIR against 4 employees over Rs 2.5 crore medicine procurement irregularitiesHaryana Launches ‘Make in Haryana Industrial Policy’A new pancreatic cancer pill may be a game changer for patientsNPPA fixes prices of 30 drugs including Vitamin D3, calcium supplementsMaharashtra FDA seizes ₹73 lakh worth of medicines in crackdown on misleading health claims in adsIndustry asks NPPA to implement SOTS Scheme to resolve pending litigationsA Non- Smoker Smoking Hot Spouse needed for Actress Neetu ChandraGene 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 manufacturing
June 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.

    • admin

    Related Posts

    Probe report into maternal deaths sparks Kota row
    Probe report into maternal deaths sparks Kota row

    Rajasthan Health Minister Gajendra Singh Khinvsar confirmed that government has received the report and is conducting a review JAIPUR: The report of the probe into the deaths of five pregnant women…

    Continue reading
    Centre bans 16 Fixed-Dose Combination drugs over safety concerns
    Centre bans 16 Fixed-Dose Combination drugs over safety concerns

    The Centre has imposed an immediate ban on 16 Fixed Dose Combination (FDC) drugs. The Ministry of Health and Family Welfare issued the orders under Section 26A of the Drugs…

    Continue reading

    Leave a Reply

    Your email address will not be published. Required fields are marked *

    You Missed

    Probe report into maternal deaths sparks Kota row

    Probe report into maternal deaths sparks Kota row

    Centre bans 16 Fixed-Dose Combination drugs over safety concerns

    Centre bans 16 Fixed-Dose Combination drugs over safety concerns

    Maha FDA seizes medicines worth Rs 9.09 lakh from Mumbai children’s hospital over alleged illegal sale

    Maha FDA seizes medicines worth Rs 9.09 lakh from Mumbai children’s hospital over alleged illegal sale

    CDSCO constitutes consultancy committee for advice on suo motu disclosure

    CDSCO constitutes consultancy committee for advice on suo motu disclosure

    Telangana DCA busts illegal API stock, seizes drugs worth Rs 34L

    Telangana DCA busts illegal API stock, seizes drugs worth Rs 34L

    Zenré Wellness, a New Genre of Mental Care, unveils in Delhi

    Zenré Wellness, a New Genre of Mental Care, unveils in Delhi