Strides Pharma arm gets EIR from USFDA for Florida facility
The Florida 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 Pharma said.
New Delhi: Strides Pharma Science Ltd (Strides) on Monday said its arm has received an Establishment Inspection Report (EIR) from the US health regulator for its Florida facility in the US. Strides Pharma Inc received EIR from the United States Food and Drug Administration (USFDA) for the inspection conducted at its unit in December last year.
"Strides today 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," it said in a filing to the BSE.
The 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, it said.
Strides have a 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 the market for market' products," the filing said.
Strides will kickstart the site transfers of its existing SGC portfolio to the site with immediate effect.
In the future, the company said, it 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 programmes, including procurements administered by the Department of Veterans Affairs.