Alembic Pharmaceuticals Limited today announced that the Company 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.

Recently, Alembic Pharmaceuticals Limited also announced that the Company has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Empagliflozin and Metformin Hydrochloride Tablets, 5 mg/500 mg, 5 mg/1000 mg, 12.5 mg/500 mg, and 12.5 mg/1000 mg. The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Synjardy Tablets, 5 mg/500 mg, 5 mg/1000 mg, 12.5 mg/500 mg, and 12.5 mg/1000 mg, of Boehringer lngelheim Pharmaceuticals, Inc. (Boehringer lngelheim). Empagliflozin and Metformin Hydrochloride Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both empagliflozin and metformin hydrochloride is appropriate Empagliflozin and Metformin Hydrochloride Tablets, 5 mg/500 mg, 5 mg/1000 mg, 12.5 mg/500 mg, and 12.5 mg/1000 mg have an estimated market size of US$ 172 million for twelve months ending March 2020 according to IQVIA. Alembic is currently in litigation with Boehringer lngelheim in the District Court of Delaware and the launch of the product will depend on litigation outcome.

Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company that 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. Alembic is one of the leaders in branded generics in India. Alembic's brands, marketed through a marketing team of over 5000 are well recognized by doctors and patients