Latest News: India’s Pharma Sector Must Expand AI Use Beyond R&D: ReportsIndia headed for Culture of ‘Divya Buildings’, thanks to AMTZ’s Landmark InitiativeIndia’s Pharma, Healthcare Funding Hits $38.6 Mn in Nov’25Novo Nordisk gears up for December Ozempic launchIllegal intoxicant tablets seized in large quantity from Sirsa medical store, two heldHigher pharma, chemicals exports to Russia bloc on agenda to trim deficitED attaches Rs 2.58 crore property of HP Assistant Drug ControllerInter-State drug racket busted; five arrestedJubilant Pharmova names Daniel J O’Connor as CEO of proprietary drugs bizCough syrup death strigger probe into 700+drugfirmsWHO backs use of GLP-1 drugs for weight loss, along with diet, exerciseUS, UK ink tariff-free deal to boost pharma tradeLupin gets U.S. FDA nod for biosimilarFSSAI orders nationwide crackdown on illegal use of industrial dye Auramine in food productsSun Pharma launches blockbuster plaque psoriasis drug Ilumya in IndiaMumbai Businesswoman Allegedly Stripped Naked At Gunpoint By Pharma BossCodeine cough syrup syndicate kingpin’s father, a trader, arrestedSuperbugs now resistant to key everyday antibiotics: ICMR34 hospitals, 431 pharma stores suspended from RGHS for fraud in three monthsCipla launches India’s first dedicated lung health diagnostics centreTorrent Pharma fined Rs 41 crore over alleged wrong GST refundGeneric HIV Drug Rollout to Take a Hit on Trial PushStop illegal sales now: Jharkhand HC mandates prescriptions for cough syrups; State drug controller to ensure compliance and conduct raidsPiyush Goyal meets pharma stakeholders to discuss growth, regulation amid global tariff concernsUS FDA approves Novartis’ gene therapy for rare muscle disorderEris Lifesciences to pick up remining 30% in Swiss Parenterals for ₹423 croreDr Reddy’s gets EC nod for AVT03: New Prolia and Xgeva biosimilar set to launch across EuropeTg launches 1 Bio, single-use biopharma scale-up hubIndore SEZ exports jump 32 pc due to increased orders from pharma unitsEli Lilly becomes first pharma major to enter $1 trillion M-Cap club; stock price rises 1.7% on Wall St.MNC drugmakers push for 10-yr exclusivity for trial dataCurbs on risky drugs online adsBE’s new vaccine for pneumonia gets WHO approvalIndia’s Drug Regulator Finds 211 Medicines As Not Of Standard Quality In OctoberInternational wake up Call for Sleep Disorders in ChildrenSudeep Pharma IPO: From business overview, financials to key risks— 10 key things to know from RHPSolara Active Pharma Sciences Mangalore facility successfully completes USFDA inspectionDoctor faces FIR for administering expired vaccine to 2.5-month-old, assaulting parentsRestricted pills in car lead to shadow pharmacy empire stretching from Kanpur to Ludhiana.Gang which supplied Rs100 cr codeine cough syrup bustedMahima Choudhary was ‘Lucky’ Cancer lurking behind her ‘Choli’ was caught earlyUjjain Set to Become Medical Device Manufacturing Hub: 11 Major Firms Pledge ₹600 Crore Investment, 1,700+ JobsZydus Lifesciences gets USFDA nod for Leuprolide Acetate injectionLupin launches generic injection in US with 180-day exclusivityPCI directs State Councils to strictly comply with norms related to appointment of registrarsNovartis Phase III trial for malaria treatment KLU156 (GanLum) meets primary endpoint, with potential to combat antimalarial resistanceMedical Negligence Alleged as Nine Patients Suffer Severe Eye Infections After Cataract Surgery in Chhattisgarh Government HospitalIndia’s Domestic Medical Device Industry lords it over in UK ParliamentRampant Quackery in Rural India: Unqualified ‘Doctors’ Amass Fortunes Amid Lax EnforcementUP Drug Raid in Kanpur: ₹7.5 Crore Worth of Narcotics Seized; Two Officials Removed for LapsesUse of anti-haemophilia medicine suspended across Punjab after reports of adverse reactionsColdrif syrup deaths: Medical store owner and pharmacist arrestedCipla, Natco Pharma, Hetero Labs among Indian firms chosen to supply key generic drugs in ChinaNationwide Crackdown: Misused Cough Syrups, Pills, and Injections Seized Across IndiaTragic Death of Infant After Vaccination Sparks Negligence Allegations in ChhattisgarhCough Syrup Took Betul Boy’s VoiceComply with global practices by Jan 1 or shut shop: CDSCO to pharma manufacturers after cough syrup deathsNovo Nordisk Partners With Emcure To Launch Weight Loss Drug Poviztra In IndiaSeven state-of the-art common infra facilities to come up at Ujjain Medical Devices ParkKala Amb firm linked to drug racket sealed by NCBExpired medicines: 2 hospitals barred from PM-JAYCDSCO Issues Directive for Strict Enforcement of Revised Schedule M Amid Drug Quality ConcernsIIT Madras Researchers develop Affordable, Minimally Invasive Glucose Monitoring Device for Diabetes PatientsRising Tide of Spurious Drugs in India: Recent Cases Highlight Nationwide Crackdown Amid Quality ConcernsAGTF arrests man accused of smuggling drugs into USA by concealing them in granite lampsDCA raids expose steroid trade in Hyd gymsSPARSH Hospitals is poised to ‘Touch’ with Compassion Lives of Cancer PatientsNationwide Crackdown on Narcotics: Police Bust Drug Peddling Networks Across India with Seizures of Cough Syrups, Pills, and CapsulesDelhi HC questions Patanjali ad calling rival Chyawanprash brands ‘dhoka’Best in Class Surgical Robot SSIMantra now has Best Console ‘MantrAsana’Alprazolam manufacturing factory busted in Valsad, drugs worth ₹22 crores seized; four heldIndia’s 1st indigenous CAR-T Cell Therapy unveiledMassive Haul in Ghaziabad: 15.7 Lakh Banned Codeine Cough Syrup Bottles Seized, 8 Arrested in Interstate Smuggling RacketUP FSDA seizes illegal codeine syrups worth lakhs in statewide crackdownMan arrested for stealing drugs from psychiatric clinicFSSAI advisory on environmentally compliant disposal seized, expired food items in rivers90% reduction in cancer drug prices: ‘Karunya Sparsh’ programme expanded1 in 9 persons tested found positive for infectious disease in ICMR studyViral ‘Molecule’ Pill Sparks Health Crisis Among Russian Teens‘Redefining Abilities’— Leaders Call for Inclusion & Empowered Living for AllChaibasa Blood Bank Scandal Exposes Years of Regulatory LapsesDCGI delegates powers to Joint Drug Controllers to drive faster approvalsAfter the death of children, MP AYUSH department seized Ayurvedic medicines and sent samples for testingAI Deepfakes Hijack Voices of Politicians and Celebrities to Scam Diabetics with Bogus CuresTwo More Infant Deaths from Suspected Toxic Cough Syrup RockRewa Crackdown: Collector Pratibha Pal Orders Sealing of Over a Dozen Medical Stores in Fake Drugs ScandalHealth ministry issues draft rules to debar applicants submitting misleading or forged information22 de-addiction centres in Punjab Under ED lensJharkhand’s Blood Scandal: Govt Suspends Officials, Launches Probes Amid Calls for NAT Testing MandateFormer Asst. Drugs Controller Gets 2-Yr RI in DA CaseMvPI reviews 47,614 medical device associated adverse event cases in the past 10 yearsEli Lilly and Nvidia team up to build ‘most powerful’ AI supercomputer in pharmaPost-Chhindwara Alarm: MP and Haryana Pledge Drug Lab Upgrades Amid Long-Standing Regulatory LapsesBarcode and QR code system introduced in MP to ensure drug authenticity; curb rising cases of counterfeit medicinesIndia advances anti-dumping probe into ‘Ethambutol Hydrochloride’ imports from China, ThailandAIIMS Guwahati raises concern over unauthorised yellow fever vaxWrong medicine without a prescription, 5-month-old infant died: FIR against Medical store ownerQuality issues with cancer drugs in Africa pose a severe risk to patients: StudyTheft at Barnala’s Aam Aadmi Clinic Leaves De-Addiction Patients in DistressDrug Menace Escalates: Poisonous Syrups and Narcotic Seizures Spark Nationwide Alarm
December 7, 2025
Latest News: India’s Pharma Sector Must Expand AI Use Beyond R&D: ReportsIndia headed for Culture of ‘Divya Buildings’, thanks to AMTZ’s Landmark InitiativeIndia’s Pharma, Healthcare Funding Hits $38.6 Mn in Nov’25Novo Nordisk gears up for December Ozempic launchIllegal intoxicant tablets seized in large quantity from Sirsa medical store, two heldHigher pharma, chemicals exports to Russia bloc on agenda to trim deficitED attaches Rs 2.58 crore property of HP Assistant Drug ControllerInter-State drug racket busted; five arrestedJubilant Pharmova names Daniel J O’Connor as CEO of proprietary drugs bizCough syrup death strigger probe into 700+drugfirmsWHO backs use of GLP-1 drugs for weight loss, along with diet, exerciseUS, UK ink tariff-free deal to boost pharma tradeLupin gets U.S. FDA nod for biosimilarFSSAI orders nationwide crackdown on illegal use of industrial dye Auramine in food productsSun Pharma launches blockbuster plaque psoriasis drug Ilumya in IndiaMumbai Businesswoman Allegedly Stripped Naked At Gunpoint By Pharma BossCodeine cough syrup syndicate kingpin’s father, a trader, arrestedSuperbugs now resistant to key everyday antibiotics: ICMR34 hospitals, 431 pharma stores suspended from RGHS for fraud in three monthsCipla launches India’s first dedicated lung health diagnostics centreTorrent Pharma fined Rs 41 crore over alleged wrong GST refundGeneric HIV Drug Rollout to Take a Hit on Trial PushStop illegal sales now: Jharkhand HC mandates prescriptions for cough syrups; State drug controller to ensure compliance and conduct raidsPiyush Goyal meets pharma stakeholders to discuss growth, regulation amid global tariff concernsUS FDA approves Novartis’ gene therapy for rare muscle disorderEris Lifesciences to pick up remining 30% in Swiss Parenterals for ₹423 croreDr Reddy’s gets EC nod for AVT03: New Prolia and Xgeva biosimilar set to launch across EuropeTg launches 1 Bio, single-use biopharma scale-up hubIndore SEZ exports jump 32 pc due to increased orders from pharma unitsEli Lilly becomes first pharma major to enter $1 trillion M-Cap club; stock price rises 1.7% on Wall St.MNC drugmakers push for 10-yr exclusivity for trial dataCurbs on risky drugs online adsBE’s new vaccine for pneumonia gets WHO approvalIndia’s Drug Regulator Finds 211 Medicines As Not Of Standard Quality In OctoberInternational wake up Call for Sleep Disorders in ChildrenSudeep Pharma IPO: From business overview, financials to key risks— 10 key things to know from RHPSolara Active Pharma Sciences Mangalore facility successfully completes USFDA inspectionDoctor faces FIR for administering expired vaccine to 2.5-month-old, assaulting parentsRestricted pills in car lead to shadow pharmacy empire stretching from Kanpur to Ludhiana.Gang which supplied Rs100 cr codeine cough syrup bustedMahima Choudhary was ‘Lucky’ Cancer lurking behind her ‘Choli’ was caught earlyUjjain Set to Become Medical Device Manufacturing Hub: 11 Major Firms Pledge ₹600 Crore Investment, 1,700+ JobsZydus Lifesciences gets USFDA nod for Leuprolide Acetate injectionLupin launches generic injection in US with 180-day exclusivityPCI directs State Councils to strictly comply with norms related to appointment of registrarsNovartis Phase III trial for malaria treatment KLU156 (GanLum) meets primary endpoint, with potential to combat antimalarial resistanceMedical Negligence Alleged as Nine Patients Suffer Severe Eye Infections After Cataract Surgery in Chhattisgarh Government HospitalIndia’s Domestic Medical Device Industry lords it over in UK ParliamentRampant Quackery in Rural India: Unqualified ‘Doctors’ Amass Fortunes Amid Lax EnforcementUP Drug Raid in Kanpur: ₹7.5 Crore Worth of Narcotics Seized; Two Officials Removed for LapsesUse of anti-haemophilia medicine suspended across Punjab after reports of adverse reactionsColdrif syrup deaths: Medical store owner and pharmacist arrestedCipla, Natco Pharma, Hetero Labs among Indian firms chosen to supply key generic drugs in ChinaNationwide Crackdown: Misused Cough Syrups, Pills, and Injections Seized Across IndiaTragic Death of Infant After Vaccination Sparks Negligence Allegations in ChhattisgarhCough Syrup Took Betul Boy’s VoiceComply with global practices by Jan 1 or shut shop: CDSCO to pharma manufacturers after cough syrup deathsNovo Nordisk Partners With Emcure To Launch Weight Loss Drug Poviztra In IndiaSeven state-of the-art common infra facilities to come up at Ujjain Medical Devices ParkKala Amb firm linked to drug racket sealed by NCBExpired medicines: 2 hospitals barred from PM-JAYCDSCO Issues Directive for Strict Enforcement of Revised Schedule M Amid Drug Quality ConcernsIIT Madras Researchers develop Affordable, Minimally Invasive Glucose Monitoring Device for Diabetes PatientsRising Tide of Spurious Drugs in India: Recent Cases Highlight Nationwide Crackdown Amid Quality ConcernsAGTF arrests man accused of smuggling drugs into USA by concealing them in granite lampsDCA raids expose steroid trade in Hyd gymsSPARSH Hospitals is poised to ‘Touch’ with Compassion Lives of Cancer PatientsNationwide Crackdown on Narcotics: Police Bust Drug Peddling Networks Across India with Seizures of Cough Syrups, Pills, and CapsulesDelhi HC questions Patanjali ad calling rival Chyawanprash brands ‘dhoka’Best in Class Surgical Robot SSIMantra now has Best Console ‘MantrAsana’Alprazolam manufacturing factory busted in Valsad, drugs worth ₹22 crores seized; four heldIndia’s 1st indigenous CAR-T Cell Therapy unveiledMassive Haul in Ghaziabad: 15.7 Lakh Banned Codeine Cough Syrup Bottles Seized, 8 Arrested in Interstate Smuggling RacketUP FSDA seizes illegal codeine syrups worth lakhs in statewide crackdownMan arrested for stealing drugs from psychiatric clinicFSSAI advisory on environmentally compliant disposal seized, expired food items in rivers90% reduction in cancer drug prices: ‘Karunya Sparsh’ programme expanded1 in 9 persons tested found positive for infectious disease in ICMR studyViral ‘Molecule’ Pill Sparks Health Crisis Among Russian Teens‘Redefining Abilities’— Leaders Call for Inclusion & Empowered Living for AllChaibasa Blood Bank Scandal Exposes Years of Regulatory LapsesDCGI delegates powers to Joint Drug Controllers to drive faster approvalsAfter the death of children, MP AYUSH department seized Ayurvedic medicines and sent samples for testingAI Deepfakes Hijack Voices of Politicians and Celebrities to Scam Diabetics with Bogus CuresTwo More Infant Deaths from Suspected Toxic Cough Syrup RockRewa Crackdown: Collector Pratibha Pal Orders Sealing of Over a Dozen Medical Stores in Fake Drugs ScandalHealth ministry issues draft rules to debar applicants submitting misleading or forged information22 de-addiction centres in Punjab Under ED lensJharkhand’s Blood Scandal: Govt Suspends Officials, Launches Probes Amid Calls for NAT Testing MandateFormer Asst. Drugs Controller Gets 2-Yr RI in DA CaseMvPI reviews 47,614 medical device associated adverse event cases in the past 10 yearsEli Lilly and Nvidia team up to build ‘most powerful’ AI supercomputer in pharmaPost-Chhindwara Alarm: MP and Haryana Pledge Drug Lab Upgrades Amid Long-Standing Regulatory LapsesBarcode and QR code system introduced in MP to ensure drug authenticity; curb rising cases of counterfeit medicinesIndia advances anti-dumping probe into ‘Ethambutol Hydrochloride’ imports from China, ThailandAIIMS Guwahati raises concern over unauthorised yellow fever vaxWrong medicine without a prescription, 5-month-old infant died: FIR against Medical store ownerQuality issues with cancer drugs in Africa pose a severe risk to patients: StudyTheft at Barnala’s Aam Aadmi Clinic Leaves De-Addiction Patients in DistressDrug Menace Escalates: Poisonous Syrups and Narcotic Seizures Spark Nationwide Alarm
December 7, 2025

Alembic Pharma gets USFDA nod for its antibiotic capsules

Drug firm Alembic Pharmaceuticals today said it has received approval from the US health regulator for its Doxycycline Hyclate capsules used for treatment of wide variety of bacterial infections.

The approval from the United States Food and Drug Administration (USFDA) is for the company’s abbreviated new drug application (ANDA) for Doxycycline Hyclate capsules USP, in the strengths of 50 mg and 100 mg, Alembic Pharmaceuticals said in a filing to BSE.

The product is generic version of Pfizer Inc’s Vibramycin capsules in the same strengths, it added.

“Doxycycline Hyclate capsules USP, 50 mg and 100 mg, have an estimated market size of USD 80 million for twelve months ending December 2017, according to IQVIA,” Alembic Pharma said.

The company currently has a total of 73 ANDA approvals (65 final approvals and 8 tentative approvals) from USFDA, it added.

Shares of Alembic Pharmaceuticals today closed at Rs 506.55 per scrip on BSE, up 3.32 per cent from its previous close.

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