Strides Pharma Science Ltd on Monday said it has received Establishment Inspection Report (EIR) for the inspection conducted by the USFDA in January 2020 at company’s flagship facility KRS Gardens, Bengaluru.
The inspection by the US Food and Drug Administration (USFDA) was related to specific extended release applications made from the site. Receipt of EIR confirms the successful closure of the inspections, Strides Pharma Science said in a regulatory filing.
USFDA gives EIR on closure of inspection of an establishment that is the subject of an FDA or FDA-contracted inspection.
“The 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,” it added.
The facility is also capable of manufacturing complex formulations of extended release tablets which is one of the focus areas for the company.
Strides has a large extended release portfolio for the US and other regulated markets with a capability to manufacture these products at multiple sites.
The company had recently also received EIR for Bengaluru facility from USFDA for the inspection conducted in March 2020, it added.