Drugmaker Wockhardt on Wednesday notified the stock exchanges that there were no findings by US FDA with respect to data security and control measures in laboratory and manufacturing at its Chikalthana facility in Aurangabad. However, the US drug regulator is yet to notify its final decision to concerned stakeholders, and the process may typically stretch between three to six months.
Wockhardt clarified that the inspection was a follow up of the inspection by the US FDA as an outcome of completion of good manufacturing practices (GMP) remediation submitted in October 2014.
“The audit focus was to assess our good manufacturing practices (GMP) remediation and our efforts made to bring about active change and build a robust quality management”, it said in the statement.
The US FDA’s observations pertained to products that were manufactured prior to execution and implementation of GMP remediation process.
In November 2013, the US FDA had imposed an import alert on Wockhardt’s manufacturing facility. According to analysts, the Chikalthana plant contributed around 25-30% to Wockhardt’s annual sales.
Wockhardt manufactured the generic version of cardiac drug Toporol at the Chikalthana plant. It had a market share of 26% in the US for Toporol. In Q3FY15, Wockhardt’s US revenue de-grew by 47.7% on a year-on-year basis to R280 crore.