Alembic Pharma rises after tentative USFDA approval for Bimatoprost

Alembic Pharmaceuticals rose 2.41% to Rs 606.70 at 11:16 IST on BSE after the company said it has received US drug regulator's tentative approval for Bimatoprost ophthalmic solution.

The announcement was made during trading hours today, 6 August 2018.

Meanwhile, the S&P BSE Sensex was up 201.10 points, or 0.54% to 37,757.26.

On the BSE, 7,836 shares were traded in the counter so far compared with average daily volumes of 12,000 shares in the past two weeks. The stock had hit a high of Rs 613 so far during the day, which is also 52-week high for the counter. The stock had hit a low of Rs 592.70 so far during the day. The stock hit a 52-week low of Rs 412.40 on 24 May 2018.

Alembic Pharmaceuticals announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Bimatoprost ophthalmic solution, 0.03%. The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLQ), LATISSE ophthalmic solution, 0.03% of Allergan. Bimatoprost ophthalmic solution, 0.03% is indicated to treat hypotrichosis of the eyelashes by increasing their growth including length, thickness and darkness.

Bimatoprost ophthalmic solution, 0.03% has an estimated market size of $63 million for twelve months ending December 2017 according to IQVIA. Alembic is currently in litigation with Allergan in District Court of New Jersey and the launch of this product will depend on the outcome of litigation.

Alembic now has a total of 76 ANDA approvals (64 final approvals and 12 tentative approvals) from USFDA.

On a consolidated basis, net profit of Alembic Pharmaceuticals rose 35.67% to Rs 90.48 crore on 33.07% increase in net sales to Rs 862.53 crore in Q1 June 2018 over Q1 June 2017.

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

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