Granules Pharma clears US FDA inspection with zero observation; shares gain

This is Granules India’s fourth FDA audit since March with zero observations.

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Shares of Granules India edged up 1 percent in the early trade on August 4 after the company completed an inspection by the US Food and Drug Administration (USFDA).

The company’s wholly owned foreign subsidiary Granules Pharmaceuticals, Inc (GPI) located in Chantilly in Virginia, USA, has successfully completed the FDA Post-marketing Adverse Drug Experience (PADE) inspection for all its entities in the US, including Granules India Limited.

The inspection was conducted from July 31 to August 3 and closed with zero observations, the company said.

This inspection covered the Granules’ PADE surveillance, receipts, evaluations, processing and reporting system for the marketed drug products worldwide.

This is Granules India’s fourth FDA audit since March with zero observations.

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The meeting of the board of directors of the company is scheduled to be held on August 9, 2023 to consider and approve the un-audited financial results for the first quarter ended on June 30, 2023.