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Tentative US FDA approval for Wockhardt’s generic prostate drug tamsulosin capsules

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Wednesday, September 30, 2009, 12:22 This news item was posted in Industry category and has 0 Comments so far.

Wockhardt has received tentative approval for generic tamsulosin hydrochloride from the United States Food & Drug Administration (US FDA).

Wockhardt’s tamsulosin hydrochloride is the generic version of Flomax, marketed in the United States by Boehringer Ingelheim.

Tamsulosin is used for treating benign prostatic hyperplasia (BPH) or non-cancerous enlargement of prostate.

Wockhardt received conditional approval from US FDA for marketing the 0.4mg capsules of tamsulosin hydrochloride.

Wockhardt plans to launch its tamsulosin hydrochloride in the US market immediately after the patent expiry of Flomax which is set for April 27, 2010, the company said in a press release.

The total market for tamsulosin capsules in the US is about $1,650 million, according to IMS.

“This [tamsulosin] is our third NDDS product approval in the year and establishes our competency in such technologies. Both the API and the capsules require special manufacturing facilities and we are geared to meet the market demand,”  stated Wockhardt Chairman Habil Khorakiwala.

Wockhardt will manufacture tamsulosin capsules at the US FDA certified formulation plant at Chikalthana, Aurangabad and it will use API, which is also being manufactured by Wockhardt in its FDA approved plant. Both the API and the capsules were developed in-house.

Tamsulosin is one of the most used drugs to treat BPH.

Prostate enlargement is a common condition afflicting many men above a certain age and with the growing population of the elderly in the US, the demand will continue to increase, Wockhardt release said.

Wockhardt conducts research in the areas of new drug discovery (NDD), biotech & genomics research, chemical research, pharma research, clinical research and devices development.

Wockhardt has 5 research centres and 14 world-class manufacturing plants across various countries that are compliant to international regulatory standards such as the US FDA, MHRA and other global regulatory bodies.

Wockhardt has end-to-end integrated capabilities for its products, starting with manufacture of the oral and sterile API’s, the dosage forms and marketing through its wholly owned subsidiary in the US. Wockhardt has a global footprint including the US, UK, Ireland and France with a multi-ethnic workforce from 14 different nationalities.

In April, Wockhardt announced the resignation of Habil Khoarkiwala from the position of managing director, as India’s leading generic player hit the Rs 3,400 crore debt wall. Soon after his exit,  Murtaza Khorakiwala and Hozaifa Khorakiwala took charges .

Murtaza Khorakiwala has become the new Managing Director –one of the portfolios his father held so far and Hozaifa Khorakiwala the new executive director of the over Rs 2,500 crore Wockhardt.

Wockhardt announced the completion of the divestment of its Animal Health Division to Vétoquinol, France, in August.

Head-quartered in Mumbai, Wockhardt posted a net loss of Rs 190 crore for the second quarter ended June 30, 2009, compared to a net profit of Rs 103.6 crore for the corresponding quarter of 2008, due to exceptional items like interest, exchange rate fluctuation and mark-to market (MTM) losses.

Wockhardt registered a 4.8% growth in consolidated sales revenues to Rs 954 crore for the quarter under review against Rs 910.3 crore for the corresponding quarter of 2008. Operating profit (EBIDTA) stood at Rs 168 crore.

As per ORG-IMS for the Q2 of 2009, Wockhardt’s India business grew by 9%. Wockhardt UK continues to lead the way with a growth of 11% compared to the industry growth of only 4% in Q2-2009.

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