Sun Pharma gains 4% as Dadra plant gets EIR from USFDA
The stock was up 4% to Rs 549 on the BSE in early morning trade in otherwise subdued market.
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Sun Pharmaceutical Industries was up 4% to Rs 549 on the BSE in early morning trade in otherwise subdued market, after the company said its Dadra plant gets Establishment Inspection Report (EIR) on completion of inspection.
“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.
“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.