The approved product, Tadalafil tablets, is generic version of Eli Lilly and Company’s Cialis tablet.
New Delhi: Drug firm Alembic Pharmaceuticals Wednesday said it has received approval from the US health regulator for Tadalafil tablets, indicated for the treatment of erectile dysfunction.
The approval from the United States Food and Drug Administration (USFDA) is for the company’s abbreviated new drug application (ANDA) for Tadalafil tablets USP, in the strengths of 2.5 mg, 5mg, 10mg and 20 mg, Alembic Pharmaceuticals said in a filing to BSE.
The product is generic version of Eli Lilly and Company’s Cialis tablet.
Quoting IQVIA data, Alembic Pharma said Tadalafil Tablets have an estimated market size of USD 1.8 billion for twelve months ending December 2018.
The company currently has a total of 89 ANDA approvals (77 final approvals and 12 tentative approvals) from USFDA, it added.
Alembic Pharmaceuticals Ltd. is headquartered in Vadodara city of Gujarat. The company is involved in manufacture of pharmaceutical products, pharmaceutical substances and intermediates.