Latest News: Price 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 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 Karnataka
June 13, 2026
Latest News: Price 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 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 Karnataka
June 13, 2026

Alembic Pharma gets USFDA nod for Parkinson’s treatment drug

New Delhi: Drug firm Alembic Pharmaceuticals Thursday said it has received approval from the US health regulator for Pramipexole Dihydrochloride extended-release tablets used for the treatment of Parkinson’s disease. The approval from the United States Food and Drug Administration (USFDA) is for the company’s abbreviated new drug application (ANDA) for Pramipexole Dihydrochloride extended-release tablets, in the strengths of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3 mg, 3.75 mg, and 4.5 mg, Alembic Pharmaceuticals said in a filing to BSE.

The approved product is a therapeutic equivalent to the reference listed drug product (RLD) Mirapex ER tablets, of Boehringer lngelheim Pharmaceuticals Inc.

Quoting IQVIA data, Alembic Pharma said Pramipexole Dihydrochloride extended-release tablets have an estimated market size of USD 38.6 million for twelve months ending December 2017.

The company currently has a total of 84 ANDA approvals (71 final approvals and 13 tentative approvals) from USFDA, it added.

Shares of Alembic Pharmaceuticals were trading at Rs 587.05 apiece on BSE, up 1.04 per cent from its previous close.

    • admin

    Related Posts

    Price cap on 2 key cancer drugs increased by 50%
    Price cap on 2 key cancer drugs increased by 50%

    NEW DELHI: Amid concerns over shortages of two critical cancer medicines, National Pharmaceutical Pricing Authority has approved a 50% hike in ceiling prices of Carboplatin and Cisplatin injections, citing escalating…

    Continue reading
    Hospitals can’t force patients to buy medicines from their pharmacies: Maha FDA
    Hospitals can’t force patients to buy medicines from their pharmacies: Maha FDA

    Mumbai: Food and Drug Administration (FDA) commissioner Tukaram Mundhe on Friday issued a directive to hospitals and nursing homes across the state to not make it binding on patients and their…

    Continue reading

    Leave a Reply

    Your email address will not be published.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

    You Missed

    Price cap on 2 key cancer drugs increased by 50%

    Price cap on 2 key cancer drugs increased by 50%

    Hospitals can’t force patients to buy medicines from their pharmacies: Maha FDA

    Hospitals can’t force patients to buy medicines from their pharmacies: Maha FDA

    IIT Bhubaneswar researchers develop portable device for accurate arsenic detection

    IIT Bhubaneswar researchers develop portable device for accurate arsenic detection

    Bribe of Rs 3 crore: Delhi Police inspector held, senior public servant under CBI scanner

    Bribe of Rs 3 crore: Delhi Police inspector held, senior public servant under CBI scanner

    No raids till further orders: Maharashtra tells Bombay HC in Patanjali labelling case

    No raids till further orders: Maharashtra tells Bombay HC in Patanjali labelling case

    Crackdown on Illegal Sale of Mephentermine Sulphate Injections in Warangal Gyms

    Crackdown on Illegal Sale of Mephentermine Sulphate Injections in Warangal Gyms