Strides announces successful closure of the USFDA inspection at its manufacturing site in Florida, United States
Strides Pharma Science Limited (Strides) announced that its step down subsidiary, Strides Pharma Inc. (SPI), has received an Establishment Inspection Report (EIR) from the USFDA for its facility in Riviera Beach, Florida, US. The EIR was issued as an outcome of the USFDA’s inspection of the facility in December 2019. This facility is one of the very few manufacturing facilities in the US with a soft gel capsule(SGC) manufacturing suite for formulations with containment needs.
Strides is one of the global leaders in Rx SGC with a vast portfolio of approved SGCs in the US and other regulated markets. The inspection outcome will bolster the company’s fast-growing SGC franchise in the US and will also help accelerate our foray into the private label opportunity with “in market for market” products. Strides will kickstart the site transfers of its existing SGC portfolio to the site with immediate effect.
In the future, Strides plans to expand additional dosage format suites at the Florida facility, which will mirror the capabilities of its formulations facility in Singapore and will help the company to tap opportunities under various federal government procurement programs, including procurements administered by the Department of Veterans Affairs (VA).