Strides arm receives EIR for its US facility
Strides Pharma Inc received EIR from the United States Food and Drug Administration (USFDA) for the inspection conducted at its unit it 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 has 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 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.
Shares of Strides Pharma Science were trading 0.96 per cent higher at Rs 390.50 apiece on the BSE in morning trade. SID RVK