The announcement was made during trading hours today, 20 November 2018.

Meanwhile, the S&P BSE Sensex was down 341.91 points, or 0.96% to 35,432.97.

On the BSE, 1,015 shares were traded in the counter so far compared with average daily volumes of 1,682 shares in the past two weeks. The stock had hit a high of Rs 574.75 and a low of Rs 567.15 so far during the day. The stock hit a 52-week high of Rs 664 on 27 September 2018. The stock hit a 52-week low of Rs 412.40 on 24 May 2018.

Alembic Pharmaceuticals announced that the company has received approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Vardenafil Hydrochloride orally disintegrating tablets, 10 mg (base). The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Staxyn orally disintegrating tablets, 10 mg, of Bayer Healthcare Pharmaceuticals, Inc.

Vardenafil Hydrochloride tablets are indicated for the treatment of erectile dysfunction. Alembic had previously received tentative approval for this ANDA.

Vardenafil Hydrochloride orally disintegrating tablets have an estimated market size of $8 million for twelve months ending December 2017 according to IQVIA. Alembic now has a total of 78 ANDA approvals (65 final approvals and 13 tentative approvals) from USFDA.

On a consolidated basis, net profit of Alembic Pharmaceuticals rose 64.57% to Rs 200.09 crore on 42.79% rise in net sales to Rs 1127.06 crore in Q2 September 2018 over Q2 September 2017.

Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company.