USFDA issues 3 observations to Granules India arm in its pre-approval inspection
Premium- The US health regulator US Food and Drug Administration (USFDA) has issued ‘three minor observations’ to its wholly-owned arm Granules Pharmaceuticals
Drug firm Granules India Ltd on Monday said the US health regulator US Food and Drug Administration (USFDA) has issued "three minor observations" to its wholly-owned arm Granules Pharmaceuticals, Inc (GPI) in a pre-approval inspection (PAI).
As per the company regulatory filing, 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 audit is a PAI for two of its product applications filed from this facility. The USFDA issued three minor observations during the audit conducted at the facility," the company's regulatory filing stated, without elaborating on the nature of the observations.
Meanwhile, 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."
Additionally, just last week on Friday, Granules India said it has received approval from the US health regulator to market Potassium Chloride, which is used to treat low blood levels.
The USFDA has approved the abbreviated new drug application (ANDA) for Potassium Chloride for Oral Solution filed by Granules Pharmaceuticals Inc (GPI), a wholly-owned foreign subsidiary of the company.
Potassium Chloride is used to prevent or to treat low blood potassium levels (hypokalemia). The product would be available for the US market shortly, Granules India said in a statement.
"We are pleased to receive the approval of the product and will surely be a valuable addition to our growing product portfolio in the US market," GPI Executive Director Priyanka Chigurupati noted. Granules stated that it now has a total of 49 ANDA approvals from the USFDA.
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