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04-Jul2017

Alembic Pharma gains on getting USFDA's nod for Vardenafil Hydrochloride Orally Disintegrating Tablets

Alembic Pharmaceuticals is currently trading at Rs. 516.00, up by 1.20 points or 0.23% from its previous closing of Rs. 514.80 on the BSE.

The scrip opened at Rs. 515.80 and has touched a high and low of Rs. 519.00 and Rs. 509.00 respectively. So far 3156 shares were traded on the counter.

The BSE group 'A' stock of face value Rs. 2 has touched a 52 week high of Rs. 709.30 on 23-Mar-2017 and a 52 week low of Rs. 492.25 on 27-Jun-2017.

Last one week high and low of the scrip stood at Rs. 529.95 and Rs. 492.25 respectively. The current market cap of the company is Rs. 9708.57 crore.

The promoters holding in the company stood at 72.68%, while institutions and non-institutions held 13.74% and 13.58% respectively.

Alembic Pharmaceuticals has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Vardenafil Hydrochloride Orally Disintegrating Tablets, 10mg. The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) STAXYN Orally Disintegrating Tablets, 10mg, of Bayer Healthcare and is used under license by GlaxoSmithKline.

Vardenafil Hydrochloride Orally Disintegrating Tablets are indicated for the treatment of erectile dysfunction. Vardenafil Hydrochloride Orally Disintegrating Tablets have an estimated market size of $9.5 million for twelve months ending December 2016 according to IMS.

Alembic is currently in litigation with Bayer in District Court of Delaware and the launch of this product will depend on the outcome of litigation. The company now has a total of 59 ANDA approvals (52 final approvals and 7 tentative approvals) from USFDA.

Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907. The company manufactures and markets generic pharmaceuticals products all over the world.


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