“You should immediately and comprehensively assess your company‘s global manufacturing operations to ensure that systems and processes, and ultimately, the products manufactured, conform to (US) FDA requirements,†US FDA said.
In a blow to Wockhardt, the US FDA has issued a warning letter to company's US subsidiary CP Pharma.
Wockhardt shares rallied nearly 5 percent intraday Tuesday after the US health regulator excluded an antibiotic drug Ceftriaxone sodium from the import alert.
Citi has even increased its FY16-17 core EPS by 2/10 percent based on progress on regulatory front and stated that resolution of 483s at Morton Grove is positive. It also adds that risk-reward looks reasonable for Wockhardt.