Mumbai-based pharma company Wockhardt shares advanced more than 3 percent intraday Tuesday after the UK healthcare regulator said company's Chikalthana facility complied with good manufacturing practice norms.
Wockhardt shares rallied nearly 5 percent intraday Wednesday after the approval by UK health regulator to Daman-based facility continued.
In a blow to Wockhardt, the US FDA has issued a warning letter to company's US subsidiary CP Pharma.
The US Food and Drug Administration (FDA) has given a clean chit to the Chikalthana plant of Wockhardt, reports CNBC Awaaz quoting sources. Official announcement from the FDA is expected in couple of weeks.
Macquarie has downgraded it to neutral from outperform and reduced target price to Rs 1015 versus Rs 1350 per share. It says Ankleshwar facility receiving under import alert may lead to multiples falling under pressure in the near term. However, it remains bullish on the stock for long term.
This will negatively impact the company's US business and lead to a negative sentiment in the markets on Monday.
The US Food & Drug Administration (FDA) has inspected the company's plant, which has lasted for five days and ended on June 10, 2016.
Anand Rathi's channel checks indicate EIR is in place for two facilities, Waluj and Chikalthana and implies positive step towards resolution of regulatory trends.
The UK health regulator MHRA has completed inspection of its plant at Chikalthana in Maharashtra without issuing any critical observations on the facility.
This is positive for Wockhardt as USFDA approvals were slowing due to import alert in its facilities. Wockhardt's L1 Chikalthana facility was under import alert for its drug Metoprolol XR used for treating blood pressure.
Pharma major Wockhardt on Friday said it is hopeful of early resolution of the issues with the US Food and Drug Administration (FDA), which has hit company's performance severely over the past few quarters.
Habil Khorakiwala said the US FDA has completed its inspection at the Waluj facility. The US FDA also visited the Chikalthana and Aurangabad plans, he said.
Wockhardt's L1 Chikalthana facility was under import alert for its drug Metoprolol XR used for treating blood pressure, while the Waluj facility that makes injectables and solid dosages was also put under import restrictions by the US Food and Drug Administration (USFDA) in 2013.
Habil Khorakiwala, chairman, Wockhardt Ltd addressed the media after the US health regulator said it did not find any issues with respect to data security and control measures at Chikalthana plant in a recent inspection.
During the October-December quarter, its net profit slumped to Rs 304 crore from Rs 428 crore a year earlier. Total sales dropped 14 percent to Rs 1237 crore.
In November, the US Food and Drug Administration issued an import alert, effectively a ban, against Wockhardt's Chikalthana plant in western India. The FDA had imposed a ban on the company's Waluj plant in May.
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.
The US FDA has said that it is concerned about Wockhardt's responses to the health regulator's queries and lab records are not in compliance with established standards. It also added that comany did not take appropriate actions to resolve defects while actual samples were used as 'trial' injections.
Dr Reddy‘s has been among the best performers in the pharma sector this calendar, gaining around 33 percent so far.
USFDA has issued Form 483 with their observations and the company does admit that some of these observations are serious in nature.