In a blow to Wockhardt, the US FDA has issued a warning letter to company's US subsidiary CP Pharma.
US FDA has issued a Form 483 to Wockhardt making certain observations with respect to manufacturing practices at its Shendra unit. The following are the observations.
Habil Khorakiwala, Founder, Chairman and Group CEO, Wockhardt says all facilities were inspected in the past six months and none of the US FDA observations are critical in nature, while adding that all these observations will be resolved in next 2-3 months
The company, whose shares slumped 15.04 percent on NSE to close at Rs 1,287.00 today, however, said being a new unit, there is no export from the Shendra facility to the US
The Delhi Mumbai Industrial Corridor Development Corporation (DMICDC) Trust, headed by the finance secretary, has given its approval to start the tendering process for three engineering, procurement and construction (EPC) contracts worth Rs 2,486 crore for Dholera city in Gujarat.
The brokerage had a cautious view on the stock for past year, awaiting better visibility by regulatory issues and future approvals but Form 483 issued by the US FDA in early 2014 on the Morton Grove US facility has now been resolved, which provides significant comfort around the sustainability of the remaining US business.
Kumar said DMICDC has decided to go ahead with five cities in all, the other three being in Greater Noida, Madhya Pradesh and Haryana.
The pharma company ran into trouble with US FDA on violation of various norms in its manufacturing units. Its plants in Waluj, Chikalthana and Daman are under scanner.