Alembic gets USFDA approval for vardenafil hydrochloride

The company has received USFDA approval for vardenafil hydrochloride orally disintegrating Tablets, 10 mg. The shares of the company were trading 0.97 per cent higher.

Alembic Pharmaceuticals received the US Food and Drug Administration for its Abbreviated New Drug Application (ANDA) verdenafil hydrochloride orally disintegrating tablets, 10 mg (base). The tablet is indicated to treat erectile dysfunction. The tablet is therapeutically equivalent to the reference listed product (RLD) Staxyn orally disintegrating Tablets, 10 mg, of Bayer Healthcare Pharmaceuticals.

According to the IQVIA stats, vardenafil hydrochloride orally disintegrating Tablets, 10 mg, have an estimated market size of US$8 million for 12 months ending December 2017.

Alembic Pharmaceuticals Limited, a vertically integrated research and development pharmaceutical company engaged in developing formulations and active pharmaceutical ingredients (API). The Company focuses on anti-infective, analgesic and, cough and cold therapies. It also focuses on therapies, such as cardiology, diabetes, gynaecology, gastrointestinal, orthopaedic, dermatology and ophthalmology.

On Tuesday, the shares of the company opened at Rs. 572.95 per share against Monday’s close of Rs. 562.60 on the BSE. At 14:47 hours, the shares of the company were trading at Rs 567.15, up by 0.81per cent. The intraday high was Rs 574.75 and intraday low was Rs. 566.80 per share on the BSE. Its 52-week high was Rs. 664 and 52-week low was Rs. 412.40 per share on the BSE.