USFDA issues 3 minor observations to Granules India arm in pre-approval inspection
Commenting on the audit, GPI Executive Director Priyanka Chigurupati said, "We are glad to have completed yet another audit with minor observations that we will respond to within the stipulated time period".
New Delhi: Drugmaker Granules India Ltd on Monday said the US health regulator has issued "three minor observations" to its wholly-owned arm Granules Pharmaceuticals, Inc (GPI) in a pre-approval inspection (PAI). Granules Pharmaceuticals located in Chantilly, Virginia, US, had undergone a PAI by the US Food and Drug Administration (USFDA) from January 24-28, 2022, the company said in a statement.
Commenting on the audit, GPI Executive Director Priyanka Chigurupati said, "We are glad to have completed yet another audit with minor observations that we will respond to within the stipulated time period".
Granules India is a vertically integrated, high-growth pharmaceutical company with an increasing presence all over the world. Headquartered in Hyderabad, India, Granules offers collaborative and strategic partnerships to global pharmaceutical leaders by producing API, PFI and FD through manufacturing excellence, process innovation, and regulatory expertise. The company's Current Product portfolio comprises growth-oriented stable APIs, PFIs & FDs that cater to the needs of global giants. Now, we are also distributing our own labeled products to various global markets.
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