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    Alembic Pharma gets USFDA nod for Pramipexole Dihydrochloride extended-release tablets

    Farhat NasimWritten by Farhat Nasim   |  
    Alembic Pharma gets USFDA nod for Pramipexole Dihydrochloride extended-release tablets
    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.


    New Delhi: Drug firm Alembic Pharmaceuticals 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 Ingelheim 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.


    Alembic Pharmaceuticals Ltd. is an Indian multinational pharmaceutical company headquartered in Vadodara city of Gujarat. Alembic Pharmaceuticals Ltd. is involved in the manufacture of pharmaceutical products, pharmaceutical substances and intermediates.

    Abbreviated New Drug ApplicationAlembic PharmaAlembic PharmaceuticalsANDABoehringer Ingelheim PharmaceuticalsChemist PharmacyClinical pharmacyDruggistFDAgeneric medicineHealth / MedicineHospital PharmacyMedical pharmacymedicineMirapex ER tabletsParkinson diseaseParkinson's diseasePharmaceuticalspharmacyPharmacy StorePramipexole DihydrochloridePramipexole Dihydrochloride extended-release tabletsPrescribed MedicineTablet medicineUnited States Food and Drug AdministrationUSUSFDA
    Source : With input

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    Farhat Nasim
    Farhat Nasim

      Farhat Nasim joined Medical Dialogue an Editor for the Business Section in 2017. She Covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She is a graduate of St.Xavier’s College Ranchi. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751 To know about our editorial team click here

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