Latest News: IndiaAI, 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 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 regulations
May 11, 2026
Latest News: IndiaAI, 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 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 regulations
May 11, 2026

Biocon gets USFDA nod for generic product

Biotechnology major Biocon on Thursday said its unit has received approval from the US health regulator to market a generic product.

Biocon Pharma, a subsidiary of the company, has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Mycophenolic Acid, the company said in a regulatory filing.

The product is indicated for the prophylaxis of organ rejection in adult patients receiving a kidney transplant and is available in 180mg and 360mg strengths.

This approval further adds to Biocon’s portfolio of vertically integrated complex drug products, the company noted.

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