Wockhardt enters the US market with Zithromax
Gets US FDA nod to launch generic version of the broad-spectrum antibiotic
Mumbai, 12 Feb,2008
Pharmaceutical and biotechnology major Wockhardt will be launching Azithromycin tablets in the United States. Wockhardt Limited received approval from the United States Food & Drug Administration (US FDA) for marketing the tablets containing 250mg, 500mg and 600mg Azithromycin, which is used for treating various kinds of infections. Azithromycin is the generic name for the brand Zithromax, sold in the US by Pfizer.
“Wockhardt is only one of the four companies to have received this approval,†said Wockhardt Chairman Habil Khorakiwala. â€Development of Azithromycin is a reflection of Wockhardt’s strong R&D for bulk drugs and formulations. This again is proof of Wockhardt’s commitment and dedication to developing innovative technologies, to capture opportunities in the USA.â€
Wockhardt’s Azithromycin tablets will be launched in the US market immediately. According to IMS, the total market for Azithromycin tablets in the US is $0.7 billion equivalent to nearly 250 million tablets. It is used in treating several kinds of infections and is one of the most potent, powerful and safe antibiotics.
In the prescription generic pharmaceutical market, Wockhardt has been consistently growing market shares for all its products. Wockhardt today markets over fifty products in the US.
The Azithromycin API is manufactured in the FDA approved API facility at Ankleshwar, Gujarat and the tablets are manufactured at the US FDA certified formulation plant at Aurangabad, Maharashtra. The API and the product were developed in-house.
Wockhardt is one of the few companies with end-to-end integrated capabilities for its products, starting with manufacture of the oral and sterile API’s, the dose forms and marketing through the wholly-owned subsidiary in the US, enabling the company to capture maximum value.
Wockhardt Limited is a global pharmaceutical and biotechnology major with an innovative research and development programme. Wockhardt has global footprints including UK, France, Germany, Ireland and USA. Wockhardt employs around 6000 people worldwide belonging to 14 different nationalities.