Strides Pharma Science Ltd has received Establishment Inspection Report (EIR) for the inspection conducted by the US Food and Drug Administration (USFDA) in January 2020 at KRS Gardens, Bengaluru.
The inspection was related to specific extended-release applications made from the site, and the receipt of EIR confirms the successful closure of the inspections, the company said in a statement.
KRS Gardens, the company’s flagship facility in Bengaluru is the largest manufacturing facility for the company with capabilities to produce finished dosage formulation products across multiple dosage formats including tablet, capsules, ointments, creams and liquids. The facility is also capable of manufacturing complex formulations of extended-release tablets.
Strides have a large extended-release portfolio for the US and other regulated markets with a capability to manufacture these products at multiple sites, it added.
Strides had recently received EIR for the Bengaluru facility from USFDA for the inspection conducted in March 2020.