Granules India announces three observations from USFDA at its US-based facility

The wholly-owned foreign subsidiary of Granules India, Granules Pharmaceuticals, Inc. (GPI) in Chantilly, Virginia (US) had undergone a pre-approval inspection by the US Food and Drug Administration (USFDA) from 24 to 28 January 2022.

The audit is a pre-approval inspection (PAI) for two of its product applications filed from this facility. The US-based drug regulatory body, USFDA issued three minor observations during the audit conducted at the facility.

Commenting on the audit, Priyanka Chigurupati, the executive director of GPI, stated, "We are glad to have completed yet another audit with minor observations that we will respond to within the stipulated time period."

On a consolidated basis, Granules India's net profit dropped 50.7% to Rs 80.68 crore on a 3.5% increase in net sales to Rs 888.33 crore in Q2 FY22 over Q2 FY21.

Hyderabad-based Granules India is a vertically integrated fast growing Indian pharmaceutical company. It is present in the manufacturing of entire value chain - from Active Pharmaceutical Ingredients (APIs), Pharmaceutical Formulation Intermediates (PFIs) and Finished Dosages (FDs).

Shares of Granules India advanced 2.18% to close at Rs 300.50 on BSE on Friday, 28 January 2022.

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