Alembic Pharma Vardenafil Hydrochloride Tablet gets USFDA nod to treat erectile dysfunction
Vardenafil Hydrochloride Tablets are indicated for the treatment of erectile dysfunction.
Vadodara: Alembic Pharmaceuticals Limited has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Vardenafil Hydrochloride Tablets, 2.5 mg (base), 5 mg (base), 10 mg (base), and 20 mg (base).
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Levitra Tablets, 2.5 mg, 5 mg, 10 mg, and 20 mg, of Bayer Healthcare Pharmaceuticals Inc. (Bayer).
Vardenafil Hydrochloride Tablets are indicated for the treatment of erectile dysfunction.
Vardenafil Hydrochloride Tablets have an estimated market size of US$ 35 million for twelve months ending June 2020 according to IQVIA.
Alembic now has a total of 127 ANDA approvals (112 final approvals and 15 tentative approvals) from USFDA.
Read also: Alembic Pharma To Raise Rs 1000 Crore Via QIP Issue Of Equity Shares
Alembic Pharmaceuticals Limited, a vertically integrated research and development pharmaceutical company headquartered in Gujarat.
Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world.
Alembic's state of the art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA.
Read also: Alembic Pharma Q1 Profit Jumps To Rs 301.46 Crore
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