Wockhardt has complied'

Mumbai: Wockhardt Ltd today said its Waluj plant in Aurangabad, Maharashtra, manufacturing sterile cephalosporin injectables, is yet to commercialise production for the US market.

Responding to a report that the US Food and Drug Administration has warned Wockhardt over poor record-keeping at its manufacturing facility in Walju, the company said: 'The recent FDA inspection of this plant was followed by certain observations by FDA, as addressed in their letter of February 21, 2006. Wockhardt has already complied with most of these observations. In fact, in its latest communication dated April 4, the US FDA has acknowledged Wockhardt's efforts and we are confident that this facility will be approved in the near future.'

The company has two manufacturing facilities at Aurangabad, one at Chikalthana and the other at Waluj. The Chikalthana plant was inspected and approved by FDA in February 2006. Wockhardt received FDA approval for zonisamide capsules, manufactured in this plant, in December 2005. The company also received ANDA (Abbreviated New Drug Application) approval for ranitidine 75 mg, manufactured at this plant, on February 24, the company said. Of the pending 28 ANDA applications from Wockhardt, only three pertain to the Waluj facility, the company said in a statement here today. The Chikalthana plant accounts for almost all the existing US business of Wockhardt. As such, the FDA observations will not have any impact on Wockhardt's business.

Wockhardt has already received approvals for 10 ANDAs and 28 ANDA applications are pending for approval with the FDA.