ALSO READUS FDA clears Sun Pharma's Dadra plant Pharma shares extend gain; Sun Pharma, Divi's Lab up over 10% in three days More pressure ahead for Sun Pharma stock Sun Pharma, Lupin, Dr Reddy's hit 52-week lows; Biocon slips 8% intra-day Sun Pharma Q4 net declines 14% to Rs 1,223 cr, warns of fall in FY18 sales
“We have received a communication from the US Food and Drug Administration (US FDA) releasing a copy of the Establishment Inspection Report (EIR) in respect of the company's Dadra facility inspection based upon our responses to the Form-483 observation letter,” Sun Pharma said in a BSE filing.
Dadra is Sun Pharma’s second-largest plant in India, and had received 11 adverse observations in a US FDA inspection in April. These pertained to incomplete batch records, improper storage of drugs and inadequate powers to quality control unit.
This is the second plant to clear regulatory hurdle after Mohali, which was cleared of an import alert in March.
At 09:32 AM; the stock was up 3% at Rs 541 on the BSE as compared to 0.11% decline in the S&P BSE Sensex. A combined 2.31 million shares changed hands on the counter on the BSE and NSE so far.