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The US Food and Drug Administration (FDA) has concluded its inspection of Gland Pharma's VSEZ Sterile Oncology Facility in Visakhapatnam, India, with no compliance issues found.
The inspection, which took place between 20 and 28 July 2023, concluded with Zero 483 observations. It was classified as No Action Indicated (NAI), which means that no further action is required by Gland Pharma.
The VSEZ Sterile Oncology facility, commissioned in the year 2010 started manufacturing products to the US in 2016 and to EU in 2015.
Gland Pharma is one of the largest and fastest growing injectable-focused companies, with a global footprint across 60 countries, including the United States, Europe, Canada, Australia, India, and other markets.
The company's board will consider Q1 results on 7 August 2023. It reported 72% drop in net profit to Rs 78.7 crore in Q4 FY23 from Rs 285.9 crore in Q4 FY22. Revenue from operations fell by 29% YoY to Rs 785 crore during the quarter.
Shares of Gland Pharma rose 2.12% to Rs 1294 on 28 July 2023.
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