Wockhardt gets USFDA nod for antibiotic

Wockhardt has received the US Food and Drug Administration's (FDA) approval for marketing ceftriaxone sodium injection, a broad-spectrum new generation antibiotic, in the US market.

Wockhardt USA Inc, the company's US subsidiary, is expected to launch this cephalosporin group antibiotic formulation in the next few weeks. Ceftriaxone sodium is the generic version of Hoffman La Roche's Rocephin injection.

"The approval marks Wockhardt's entry into the US injectables market," said Wockhardt Chairman Habil Khorakiwala.

"This is the first out of nine injectables that we have filed with the US FDA. We expect to launch more products, including injectables, there this year."

Wockhardt is one of the few companies with end-to-end integrated capabilities for this product, starting with manufacture of active pharmaceutical ingredient (API), formulations and marketing through the wholly owned subsidiary in the US, enabling the company to capture maximum value.

Ceftriaxone is manufactured at the company's US FDA-certified sterile cephalosporin API facility at Ankleshwar and the formulation is manufactured at the dedicated cephalosporin formulation plant at Waluj in Aurangabad, which was recently approved by the US FDA. Both the process for the API and injection were developed through in-house research.

With ceftriaxone, Wockhardt now has 12 products in the US market now, compared with five last year. Around 20 products are awaiting the US FDA approval.