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.

  • Related Posts

    • Pharma
    • July 11, 2025
    • 59 views
    India’s Glenmark Pharma unit, AbbVie sign exclusive licensing pact

    July:  India’s Glenmark Pharmaceuticals (GLEN.NS), opens new tab said on Thursday its innovation arm, Ichnos Glenmark Innovation (IGI), and AbbVie (ABBV.N), opens new tab have signed an exclusive licensing agreement…

    • Pharma
    • July 10, 2025
    • 137 views
    Pills & Profits: Can India’s pharma sector handle Trump’s planned 200% tariff dose?

    India stands tall as a pharmaceutical powerhouse, supplying 20% of the world’s generic medicines and nearly 62% of global vaccines. Yet, this success now faces a storm: US President Donald…

    Leave a Reply

    Your email address will not be published.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

    You Missed

    India’s Glenmark Pharma unit, AbbVie sign exclusive licensing pact

    India’s Glenmark Pharma unit, AbbVie sign exclusive licensing pact

    Very Arty Surgery for Weight Loss by SSI Mantra, World’s First

    Very Arty Surgery for Weight Loss by SSI Mantra, World’s First

    Pills & Profits: Can India’s pharma sector handle Trump’s planned 200% tariff dose?

    Pills & Profits: Can India’s pharma sector handle Trump’s planned 200% tariff dose?

    Novartis wins approval for first malaria drug for newborns and babies

    Novartis wins approval for first malaria drug for newborns and babies