homebusiness Newscompanies NewsUS FDA concludes audit at Granules Consumer Health’s packaging facility with zero observations

US FDA concludes audit at Granules Consumer Health’s packaging facility with zero observations

The packaging facility in Manassas is spread over 79,000 sq ft and has several packaging suites to service customer needs, the pharmaceutical company added.

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By Tanmay Tiwary  Mar 21, 2023 2:29:24 PM IST (Published)

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US FDA concludes audit at Granules Consumer Health’s packaging facility with zero observations
Pharmaceutical company Granules on Tuesday said the US FDA has concluded an audit of its arm Granules Consumer Health’s packaging facility in Manassas, Virginia. The US FDA issued Zero 483s to Granules Consumer Health (GCH), it added.

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The packaging site was inspected by the US FDA between March 15-20, 2023, Granules said in a statement.
“The audit is a pre-approval inspection for three products filed from the facility. The packaging site strengthens our proposition to control the value chain and provides us with the agility needed in a very dynamic OTC space,” said Priyanka Chigurupati, Executive- Director, Granules USA, Inc. & Granules Pharmaceuticals.
The packaging facility in Manassas is spread over 79,000 sq ft and has several packaging suites to service customer needs, the pharmaceutical company added.
Granules Consumer Health claims that its packaging facility will enable it to service leading retailers more effectively.
The company reported its Q3 earnings in January. It witnessed a surge of over 23% in its profit to Rs 124.3 crore against Rs 100.9 crore in the same quarter last year. The company also saw an improvement in its margin, which came in at 20.18% as opposed to 17.4% in the same quarter last year.
Last month, Granules received US FDA ANDA nod for Losartan Potassium tablets USP. Losartan Potassium tablets are used to treat hypertension.
The stocks of Granules India were trading at Rs 287.40 apiece, up nearly 2% at 2:00 pm.

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