Sun Pharma, India’s largest drug maker on Wednesday said it has received an establishment inspection report (EIR) from US FDA for the company’s Dadra formulation facility.
EIR indicates closure of plant inspection by the US regulatory agency.
“We have received a communication from the US FDA releasing a copy of the Establishment Inspection Report (EIR) in respect of the above inspection based upon our responses to the said observation letter,” Sun Pharma said in a statement to stock exchanges.
US FDA, which inspected the plant in April this year made 11 Form 483 observations raising compliance issues that include incomplete laboratory records, failure to create accurate duplicates of key records, failure to properly investigate drug batches that didn’t meet specifications, as well as some additional quality control issues.
Dadra is the company’s second largest USFDA-approved plant after Halol with several pending generic filings. Analysts estimate the Dadra formulation plant to generate USD 250 million in annual sales.
The closure of the Dadra inspection by US FDA comes as a huge relief for Sun Pharma, which is trying to resolve a warning letter issued to Halol facility in Gujarat. The company has completed remediation and is awaiting US FDA re-inspection for Halol facility.
The announcement came after market hours.
Shares of Sun Pharma dropped 0.28 percent to close at Rs 525.80 on BSE, the benchmark Sensex declined 0.28 percent to end 31,833.99 points.