Wockhardt gets USFDA nod to mkt Ceftriaxone injection

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Wockhardt gets USFDA nod to mkt Ceftriaxone injection

Wockhardt gets US FDA nod to market full range of Ceftriaxone antibiotic injection in US

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Wockhardt Limited has received US FDA approval for three more strengths of Ceftriaxone, enabling the company to market the full range of this potent antibiotic injection in the US market.

Wockhardt already markets Ceftriaxone 1 gm injection. The new approval is for three more strengths - 250 mg, 500 mg and 2 gm. Wockhardt manufactures its own bulk drug - active substance.

"We are launching three injection products in the US this week - Furosemide diuretic, Ketorolac anti-inflammatory and Ceftriaxone antibiotic," Wockhardt chairman Habil Khorakiwala said. "This is the fourth ANDA approval in four weeks and our sixth injection product in the US market."

Ceftriaxone injection is a cephalosporin antibiotic for intravenous and intramuscular use. It is the generic name for Rocephin sold by Roche. It is one of the most widely used antibiotics in hospitals all over the world for treating various kinds of bacterial infection, bone and joint infection, meningitis, abdominal, skin and urinary tract injections. The US consumes over 25 million vials worth $200 million a year, as per IMS.

The Ceftriaxone range will be marketed by Wockhardt's US subsidiary Wockhardt USA Inc which has steadily built a healthy relationship with hospitals, group purchasing organisations, wholesalers, doctor clinics and managed care companies in the US.

With three more products to be added this week, Wockhardt will have 20 products in the US. As the development and manufacture of the dosage forms and marketing are all undertaken in-house, Wockhardt is able to capture maximum value from its products sold in the US market.

The US is currently Wockhardt's third largest market after Europe and India.

Wockhardt Limited is an internationally approved pharmaceutical and biotechnology company having a strong and innovative research and development programme. Wockhardt has made four successful acquisitions in Europe, where it employs 850 people. Europe and US together account for over half of Wockhardt's sales.

Sourced From: Corporate Voice|Weber Shandwick