 "Lupin receives US FDA for electrolyte replenisher")
Lupin has surged 8% to Rs 1,535 on BSE, erasing its entire previous weeks’ losses, after the drug maker on Saturday said that it has received Establishment Inspection Report (EIR) from the US health regulator for its Goa plant leading to closure of all outstanding inspections of the facility. Last week, the stock had declined 6.4%.
“The company has received notification that the inspection carried out by the US Food and Drug Administration (US FDA) in March 2016 at its Goa facility is now closed and the agency has issued an Establishment Inspection Report (EIR),” Lupin said in a press release.
This closes all outstanding US FDA inspections at Lupin’s Goa facility, it added.
“We are committed to ensuring that all systems and processes followed by Lupin are compliant with good manufacturing practices (cGMP) and are committed to bringing quality products to market. We are grateful for the US FDA’s confidence in our corrective action plan and in our team. It is our goal to remain well ahead on the compliance curve,” Vinita Gupta, Chief Executive Officer and Nilesh Gupta, Managing Director, Lupin said.
At 09:26 am, the stock was up 6% at Rs 1,509 on BSE, as compared to 0.8% rise in the S&P BSE Sensex. A combined 1.07 million shares changed hands on the counter on BSE and NSE so far.
“The company has received notification that the inspection carried out by the US Food and Drug Administration (US FDA) in March 2016 at its Goa facility is now closed and the agency has issued an Establishment Inspection Report (EIR),” Lupin said in a press release.
This closes all outstanding US FDA inspections at Lupin’s Goa facility, it added.
“We are committed to ensuring that all systems and processes followed by Lupin are compliant with good manufacturing practices (cGMP) and are committed to bringing quality products to market. We are grateful for the US FDA’s confidence in our corrective action plan and in our team. It is our goal to remain well ahead on the compliance curve,” Vinita Gupta, Chief Executive Officer and Nilesh Gupta, Managing Director, Lupin said.
At 09:26 am, the stock was up 6% at Rs 1,509 on BSE, as compared to 0.8% rise in the S&P BSE Sensex. A combined 1.07 million shares changed hands on the counter on BSE and NSE so far.
