Granules clears USFDA pre-approval inspection of manufacturing site in Virginia

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The USFDA issued two minor observations during the audit, and the company had responded within the stipulated time.

Drug maker Granules India on July 21 said its manufacturing facility in the US has received an establishment inspection report from USFDA, indicating closure of audit.

The facility located at Chantilly in Virginia had undergone a Pre-Approval Inspection (PAI) audit by the USFDA from June 21 to 25.

The audit was triggered following Granules US subsidiary filing three abbreviated new drug applications from this facility.

The USFDA issued two minor observations during the audit, and the company had responded within the stipulated time

“We are happy to inform that the (US)FDA has closed the observations pertaining to this audit with an Establishment Inspection Report on the July 20. This is the fifth US FDA audit for this facility” said Priyanka Chigurupati, Executive Director at Granules.

North America, which largely constitutes the US market, contributed about 54 percent of company’s Rs 3,238 crore revenues in FY21.

The US facility has 800 million capacity of solid oral tablets and another form of formulation, on a single shift basis. The factory became operational in Q1FY22.

Please read here how Granules is transforming from commodity APIs to formulations with US focus.

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