Strides Pharma gets EIR for Bangalore facility

"The company's formulations facility (KRSG Gardens) in Bangalore which was inspected by the US Food and Drug Administration (USFDA) in August 2018 and November 2018, has received the Establishment Inspection Report (EIR), thereby confirming the successful closure of the inspections," Strides Pharma Science said in a BSE filing.

New Delhi: Headquartered in India, Strides Pharma Science Limited (Formerly Strides Shasun Limited), a drug firm with a major focus on development and manufacture of IP-led niche finished dosage formulations, recently announced it has received Establishment Inspection Report(EIR) from the USFDA for its formulation facility in Bangalore.

Drug firm StridesPharma Science Wednesday said it has received the Establishment Inspection Report (EIR) from the US health regulator for its formulations facility in Bangalore.

"The company's formulations facility (KRSG Gardens) in Bangalore which was inspected by the US Food and Drug Administration (USFDA) in August 2018 and November 2018, has received the Establishment Inspection Report (EIR), thereby confirming the successful closure of the inspections," Strides Pharma Science said in a BSE filing.

USFDA gives EIR on the closure of inspection of an establishment that is the subject of an FDA or FDA-contracted inspection.

The company further noted that the inspection conducted in November 2018 had concluded with zero 483 observations.

As per the USFDA, Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that in its judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.

The flagship facility in Bangalore manufacturers tablets, capsules, liquids, creams ointments, sachets. The facility is the largest for the company and supports several current and future products for the US markets.

Strides’ KRS Gardens facility manufactures oral dosage forms including tablets, capsules (both hard and soft gelatine). The manufacturing plant supports important current and future submissions for the US market.

Strides Pharma is also among the world's largest manufacturers of soft gelatin capsules.

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