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Granules Subsidiary Clears USFDA Pre Approval Audit

The FDA issued two minor observations during the audit, the Hyderabad-based drug firm said in a regulatory filing.

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Drug firm Granules India on Wednesday said its US-based facility has cleared an audit by the US health regulator.

Granules Pharmaceuticals, Inc (GPI), a Virginia-based wholly-owned subsidiary of the company, had undergone a pre-approval inspection (PAI) audit by the US Food and Drug Administration (FDA) from June 21 to June 25.

The FDA issued two minor observations during the audit, the Hyderabad-based drug firm said in a regulatory filing.

“The observations were responded to within the stipulated time, and we are happy to inform that the FDA has closed the observations pertaining to this audit with an Establishment Inspection Report on July 20. This is the fifth USFDA audit for this facility,' GPI Executive Director Priyanka Chigurupati said.

The EIR signifies successful closure of inspection by the regulator.

Granules has seven manufacturing facilities and a presence in 75 countries. 

(PTI)


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Granules India Drug firm pharmaceutical manufacturing