Last Updated : Monday, January 20, 2020 22:20:15

USFDA clears STRIDES PHARMA’s Florida (US) facility, issues EIR

MUMBAI | RAJKOT – In a regulatory update as submitted to the Indian Stock Exchanges, Mumbai headquartered pharmaceutical products manufacturing company Strides Pharma Science Ltd said of its Florida (US) based facility, having got cleared by USFDA (US Food and Drugs Administration) post inspection and the facility has got Establishment Inspection Report.

The press-release titled, “Strides announces successful closure of the USFDA inspection  at its manufacturing site in Florida, United States,” further read that, Strides Pharma Science Limited (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.

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).

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