Alembic Pharmaceuticals receives USFDA Approval for Tadalafil Tablets USP, 2.5 mg, 5 mg, 10 mg and 20 mg.
Deepthi | Myequity news | Date : 27-03-2019 12:42:00 IST
Alembic Pharmaceuticals Limited has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Tadalafil Tablets USP, 2.5 mg, 5 mg, 10mg and 20 mg. The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Cialis Tablets, 2.5 mg, 5 mg, 10 mg, and 20 mg, of Eli Lilly and Company (Lilly). Alembic had previously received tentative approval for this ANDA.
Tadalafil Tablets have an estimated market size of US$ 1.8 billion for twelve months ending December 2018 according to IQVIA.
About Alembic Pharmaceuticals Limited
Alembic Pharmaceuticals Limited, a vertically integrated research and development pharmaceutical company, has been at the forefront of healthcare since 1907. Headquartered in India, 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.