Latest News: Massive Eskuf haul seized from train in AgartalaVadodara Police Seize Illegal Steroids and Testosterone Injections from Russia and Austria in Bodybuilding Shop Raid35 drugs manufactured in Telangana fail CDSCO quality checksDelhi govt inspects 25 firms, collects 55 samples in crackdown on spurious anticancer drugs‘Import of Refurbished Medical Devices’ Lobby has reared its Ugly Head‘Import of Refurbished Medical Devices’ Lobby has reared its Ugly HeadJharkhand HC orders FIRover children being given HIV-infected blood during transfusionsNarco Syndicate indulged in supply of Contraband NRX medicines dismantled, arrested two key operativesHealth dept cracks down on ‘Sojat’ henna fraud by pvt cosBDMAI’s e-marketing portal to promote Indian pharma products and servicesFIR against pharma dealer for supplying dubious snake antidote to govtIndigenous Robotic Surgery is Mantra for Accessible Cancer Care in IndiaOne arrested in spurious rabies vaccine racket: Govt tells RSDrug testing lab at Baddi under lens over chronic delays, missed deadlinesAlready Nursery for Specialists, Sir Ganga Ram is Medical College in the MakingIISER Pune scientists uncover bacteria’s new survival secretNPPA fixes retail price of 36 new drugsBudget 2026: 17 cancer medicines to become cheaper as Sitharaman announces basic customs duty exemptionState warns blood banks over unethical profit through bulk transfersHealthcare Leaders lauds India’s Union Budget 2026 in no uncertain termsMinimum import price set for Penicillin G, saltsRajasthan: Probe ordered as video of nurses dancing in ICU goes viralNorms notified to skip test licences for R&D to boost pharma researchIndia-EU FTA deal could make life-saving drugs cheaperFDI equity inflow into pharma sector grows to $1.27 billion in H1 FY26Patient dies after ambulance door gets jammed at Madhya Pradesh hospital’s gateMan arrested for illegal sale of steroid injections in HyderabadSun Pharma, Cipla, Zydus, Graviti recall drugs in U.S. market16 states and 6 UTs did not submit NSQ data in December to CDSCOMaha to manufacture goatpox vaccine at its Pune instituteUnnecessary use of steroid leads to risk of severe fungal infections: DoctorsSpurious cosmetic packaging factory busted in northwest DelhiDrugs & Cosmetics Rules | 60-Day Sample Testing Mandatory; Web-Host Reports: Bombay HC Orders Strict Action Against Erring OfficersUP plans US FDA-accredited medical device testing labPatent rejected for MNC’s cancer drug, generics to followZydus brings world’s first Nivolumab biosimilar to IndiaDr Reddy’s set to start selling generic Ozempic in India at potentially half priceA total of 167 drug samples flagged as ‘not of standard quality’ in December 2025: Health MinistryUnion Minister Anupriya Patel launches NBEMS online AI training programme for doctorsEnglish alphabets can’t be trademarked: Delhi HCIIT Roorkee develops next-generation antibody discovery platformCDSCO approves highest number of new drugs with r-DNA origin for import & manufacture in 2025Spiralling Gold And Silver Prices Impact Costs Of Ayurvedic Medicines With Traces Of Precious MetalsChhattisgarh eyes investments with high-incentive policy and dedicated pharma parkCDSCO to dispose online applications pending for more than two yearsBrazil, Nigeria emerge as key export destinations; market expands to $20.48 billionUP has emerged as India’s largest Healthcare & med tech hub: YogiCentre flags serious lapses in state’s blood banksSun Pharma Launches UNLOXCYT for Advanced Skin Cancer in USUnlicensed medical device stock worth Rs. 4.47 lakh seized in Gurugram raidControlled substances charge: Court summons Ramdev, Amazon founderAllahabad HC refuses to quash case against pharma company linked to cough syrup deaths in UzbekistanIPC registers 44 small-scale medtech firms under ADRMSOver 9,000 deaths due to respiratory diseases in DelhiNebuliser, inhaler demand for children jumps by up to 60 pc in Delhi winters: SurveyPharma company, its employees convicted for ‘illegal diversion” of meth precursor abroadAyurveda practitioner fined by ISM Council for violation of professional ethicsAdministering rabies vaccine at the wrong site can be fatal: Shoulders or thighs only, warn expertsDelhi HC allows Zydus to sell biosimilar of blockbuster anti-cancer drug NivolumabDoP may exempt 11 more drugs from public procurement rulesDoP calls for proposals to set up common facilities for medical device clustersTN Information Commission raps petitioner for abusing RTI Act with excessive requestsGranules India gets USFDA tentative nod for generic ADHD treatment tabletsPolymatech begins domestic manufacturing of vein finder devicesPM Janaushadhi, PLI, PRIP major boost to pharma industryUP FSDA orders statewide verification of wholesale drug licencesDCGI releases classification of 77 medical devices related to oncologyCentre plans separate licence regime for bulk drugs, APIs: Report20kg heroin seized in Amritsar, 17-year-old boy among 4 arrestedQuality of generic drugs as good as that of costlier branded cousins: StudyJoint op in Hanumangarh leads to seizure of controlled drug used as intoxicantCDSCO brings in guidelines and SOPs on compounding of offencesAgios Pharma shares jump as U.S. FDA expands approval for blood disorder drugFormer pharma employee from Ahmedabad loses 87L in stocks fraudHome Minister Anitha seeks report on fire accident at pharma unit in APSEZPharma companies overcharged consumers by ₹10,000 crore despite price controls: dataDoP includes member of HTAIn in expert committee on pricing of drugsDraft issued to remove cough syrups from Schedule KIllegal Jan Aushadhi Centre busted in District HospitalAyush and herbal products exports decline 33% in OctoberAlmost 85% of overcharged amount claimed by NPPA yet to be recoveredLupin signs licensing pact with Gan & Lee Pharma for GLP-1 receptor agonist BofanglutideRs 700-crore cough syrup racket: UP drug regulator seeks stricter supply chain rulesMaha cops bust three factories, seize drugs worth Rs 56 crore in Bengaluru‘Drug companies in upgrade mode need more time for GMP compliance’: IDMAObesity treatment drugs to be new growth engine for pharma industry: Sun PharmaNational Pharmaceutical Pricing Authority fixes retail price of 37 new drugsMassive Drug Bust in Bijnor: CBN Seizes Over 6.5 Lakh TabletsSun Pharma unit recalls 17,000-plus bottles of antifungal shampoo in USStrides Pharma Science arm New York facility gets 4 USFDA observationsSSI Mantra, Made in India Robot, bats a Thousand by completing 100 TelesurgeriesBihar drug bust: Rs15 million narcotics seized in major trafficking crackdownTop pharma companies racing to launch first weight-loss pillAjanta Pharma shares rise 5% on Biocon weight-loss drug marketing pact4 held in Etah with banned codeine syrup worth Rs 25LDelhi Police bust fake medicine packaging racket; two arrestedPlasmaGen Biosciences secures ₹150 crore to expand into global marketsCipla launches inhalable insulin for diabetes careIndian ‘Mantra’ for USA to make Robotic Surgery Affordable and Accessible thereCentre draws a price line to curb cheap pharma imports
February 11, 2026
Latest News: Massive Eskuf haul seized from train in AgartalaVadodara Police Seize Illegal Steroids and Testosterone Injections from Russia and Austria in Bodybuilding Shop Raid35 drugs manufactured in Telangana fail CDSCO quality checksDelhi govt inspects 25 firms, collects 55 samples in crackdown on spurious anticancer drugs‘Import of Refurbished Medical Devices’ Lobby has reared its Ugly Head‘Import of Refurbished Medical Devices’ Lobby has reared its Ugly HeadJharkhand HC orders FIRover children being given HIV-infected blood during transfusionsNarco Syndicate indulged in supply of Contraband NRX medicines dismantled, arrested two key operativesHealth dept cracks down on ‘Sojat’ henna fraud by pvt cosBDMAI’s e-marketing portal to promote Indian pharma products and servicesFIR against pharma dealer for supplying dubious snake antidote to govtIndigenous Robotic Surgery is Mantra for Accessible Cancer Care in IndiaOne arrested in spurious rabies vaccine racket: Govt tells RSDrug testing lab at Baddi under lens over chronic delays, missed deadlinesAlready Nursery for Specialists, Sir Ganga Ram is Medical College in the MakingIISER Pune scientists uncover bacteria’s new survival secretNPPA fixes retail price of 36 new drugsBudget 2026: 17 cancer medicines to become cheaper as Sitharaman announces basic customs duty exemptionState warns blood banks over unethical profit through bulk transfersHealthcare Leaders lauds India’s Union Budget 2026 in no uncertain termsMinimum import price set for Penicillin G, saltsRajasthan: Probe ordered as video of nurses dancing in ICU goes viralNorms notified to skip test licences for R&D to boost pharma researchIndia-EU FTA deal could make life-saving drugs cheaperFDI equity inflow into pharma sector grows to $1.27 billion in H1 FY26Patient dies after ambulance door gets jammed at Madhya Pradesh hospital’s gateMan arrested for illegal sale of steroid injections in HyderabadSun Pharma, Cipla, Zydus, Graviti recall drugs in U.S. market16 states and 6 UTs did not submit NSQ data in December to CDSCOMaha to manufacture goatpox vaccine at its Pune instituteUnnecessary use of steroid leads to risk of severe fungal infections: DoctorsSpurious cosmetic packaging factory busted in northwest DelhiDrugs & Cosmetics Rules | 60-Day Sample Testing Mandatory; Web-Host Reports: Bombay HC Orders Strict Action Against Erring OfficersUP plans US FDA-accredited medical device testing labPatent rejected for MNC’s cancer drug, generics to followZydus brings world’s first Nivolumab biosimilar to IndiaDr Reddy’s set to start selling generic Ozempic in India at potentially half priceA total of 167 drug samples flagged as ‘not of standard quality’ in December 2025: Health MinistryUnion Minister Anupriya Patel launches NBEMS online AI training programme for doctorsEnglish alphabets can’t be trademarked: Delhi HCIIT Roorkee develops next-generation antibody discovery platformCDSCO approves highest number of new drugs with r-DNA origin for import & manufacture in 2025Spiralling Gold And Silver Prices Impact Costs Of Ayurvedic Medicines With Traces Of Precious MetalsChhattisgarh eyes investments with high-incentive policy and dedicated pharma parkCDSCO to dispose online applications pending for more than two yearsBrazil, Nigeria emerge as key export destinations; market expands to $20.48 billionUP has emerged as India’s largest Healthcare & med tech hub: YogiCentre flags serious lapses in state’s blood banksSun Pharma Launches UNLOXCYT for Advanced Skin Cancer in USUnlicensed medical device stock worth Rs. 4.47 lakh seized in Gurugram raidControlled substances charge: Court summons Ramdev, Amazon founderAllahabad HC refuses to quash case against pharma company linked to cough syrup deaths in UzbekistanIPC registers 44 small-scale medtech firms under ADRMSOver 9,000 deaths due to respiratory diseases in DelhiNebuliser, inhaler demand for children jumps by up to 60 pc in Delhi winters: SurveyPharma company, its employees convicted for ‘illegal diversion” of meth precursor abroadAyurveda practitioner fined by ISM Council for violation of professional ethicsAdministering rabies vaccine at the wrong site can be fatal: Shoulders or thighs only, warn expertsDelhi HC allows Zydus to sell biosimilar of blockbuster anti-cancer drug NivolumabDoP may exempt 11 more drugs from public procurement rulesDoP calls for proposals to set up common facilities for medical device clustersTN Information Commission raps petitioner for abusing RTI Act with excessive requestsGranules India gets USFDA tentative nod for generic ADHD treatment tabletsPolymatech begins domestic manufacturing of vein finder devicesPM Janaushadhi, PLI, PRIP major boost to pharma industryUP FSDA orders statewide verification of wholesale drug licencesDCGI releases classification of 77 medical devices related to oncologyCentre plans separate licence regime for bulk drugs, APIs: Report20kg heroin seized in Amritsar, 17-year-old boy among 4 arrestedQuality of generic drugs as good as that of costlier branded cousins: StudyJoint op in Hanumangarh leads to seizure of controlled drug used as intoxicantCDSCO brings in guidelines and SOPs on compounding of offencesAgios Pharma shares jump as U.S. FDA expands approval for blood disorder drugFormer pharma employee from Ahmedabad loses 87L in stocks fraudHome Minister Anitha seeks report on fire accident at pharma unit in APSEZPharma companies overcharged consumers by ₹10,000 crore despite price controls: dataDoP includes member of HTAIn in expert committee on pricing of drugsDraft issued to remove cough syrups from Schedule KIllegal Jan Aushadhi Centre busted in District HospitalAyush and herbal products exports decline 33% in OctoberAlmost 85% of overcharged amount claimed by NPPA yet to be recoveredLupin signs licensing pact with Gan & Lee Pharma for GLP-1 receptor agonist BofanglutideRs 700-crore cough syrup racket: UP drug regulator seeks stricter supply chain rulesMaha cops bust three factories, seize drugs worth Rs 56 crore in Bengaluru‘Drug companies in upgrade mode need more time for GMP compliance’: IDMAObesity treatment drugs to be new growth engine for pharma industry: Sun PharmaNational Pharmaceutical Pricing Authority fixes retail price of 37 new drugsMassive Drug Bust in Bijnor: CBN Seizes Over 6.5 Lakh TabletsSun Pharma unit recalls 17,000-plus bottles of antifungal shampoo in USStrides Pharma Science arm New York facility gets 4 USFDA observationsSSI Mantra, Made in India Robot, bats a Thousand by completing 100 TelesurgeriesBihar drug bust: Rs15 million narcotics seized in major trafficking crackdownTop pharma companies racing to launch first weight-loss pillAjanta Pharma shares rise 5% on Biocon weight-loss drug marketing pact4 held in Etah with banned codeine syrup worth Rs 25LDelhi Police bust fake medicine packaging racket; two arrestedPlasmaGen Biosciences secures ₹150 crore to expand into global marketsCipla launches inhalable insulin for diabetes careIndian ‘Mantra’ for USA to make Robotic Surgery Affordable and Accessible thereCentre draws a price line to curb cheap pharma imports
February 11, 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.

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