New Delhi: The US Food and Drug Administration has cleared Strides Pharma Science Ltd’s Alathur plant near Chennai after an inspection in August concluded with no adverse observations for the plant, the company said in a filing with exchanges.
“The inspection conducted in August 2019 had concluded with Zero 483 observations. The facility has recently completed a significant capacity expansion and will support the growth momentum for the US business," the company said in the filing.
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.
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.
The Puducherry plant had received a warning letter from the US FDA in July for data integrity issues, among other violations. The regulator issues a warning letter to a plant if there is inadequate remediation for its initial observations of violations at a facility.
Data integrity issues at a plant are usually taken very seriously by the US regulator as they put into question safety, effectiveness, and quality of all the drugs manufactured at the plant.
Despite the clearance from the US FDA for its Alathur plant, at 1.30 pm, shares of Strides Pharma were down 3.3% at ₹339.30 on the National Stock Exchange.