24 October 2019 | News
Strides Pharma gets USFDA inspection report with no adverse observations
Strides Pharma Science LTd., has announced that inspection by the US health regulator of its formulations facility in Alathur in Tamil Nadu has been completed without any adverse observations.
The company stated in the statement that, the inspection conducted in August 2019 had concluded with Zero 483 observations.
The Alathur facility manufactures solid dosage medicines, and was initially part of the company’s and Vivimed Labs’ 50:50 joint venture. Strides Pharma acquired the balance 50% from Vivimed Labs earlier this year. The facility has recently completed a significant capacity expansion and will support the growth momentum for the US business.
It has received the establishment inspection report (EIR), thereby confirming the successful closure of the inspections, the company added.
Clearance from the regulator for the facility will solve near term capacity issues for the company as its Puducherry plant is currently under remediation for violations of good manufacturing practices.