Alembic Pharma receives USFDA tentative approval for Binimetinib tablets
Company becomes sole first applicant for 45 mg strength, positioning itself for potential 180-day generic exclusivity in the US market
Company becomes sole first applicant for 45 mg strength, positioning itself for potential 180-day generic exclusivity in the US market
Company may qualify for 180-day generic exclusivity as sole first applicant for Bayer’s Vitrakvi capsules in the U.S.
The approved product is therapeutically equivalent to Haldol tablets of Ortho McNeil Pharmaceutical
With over three decades of extensive industry experience, Ramesh Juneja brings a strong track record of building and scaling large businesses
Pharma veteran with over three decades of industry experience to lead Alembic’s animal health growth and market expansion initiatives.
Approved product is therapeutically equivalent to Synthroid of AbbVie and is indicated for the treatment of congenital or acquired hypothyroidism
US formulations grew 11% to Rs. 564 crore as Alembic enters US branded pharmaceuticals market with launch of Pivya
Darolutamide Tablets, 300 mg, had an estimated market size of US$ 3,155 million in the United States
With over 30 years of pharmaceutical industry experience, Ponnusamy will lead Alembic’s animal health business strategy, market expansion, and operational growth initiatives
Final approval for diabetes and heart-failure drug opens access to a $10.5 billion US market opportunity, with shared exclusivity benefits.
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