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The inspection was conducted from 03 October 2023 to 12 October 2023 at Baddi, Himachal Pradesh, India facility.
At the end of inspection, USFDA issued a FDA Form 483 with 9 observations which are related to improvements in existing procedures and are addressable. The company said that it will respond to the USFDA within the stipulated time and work closely with USFDA to close the said observations.
The Pharmaceuticals company, said, “We are committed to patient safety and quality and take quality and compliance matters seriously and stand by our commitment to fully comply with the cGMP quality standards.”
Panacea Biotec is engaged in research and development, manufacturing, sales, distribution and marketing of pharmaceuticals and vaccines.
On a consolidated basis, Panacea Biotec reported net profit of Rs 10.98 crore in Q1 June 2023 as against net loss of Rs 56.14 crore in Q1 June 2022. Net sales rose 16.70% YoY to Rs 129.19 crore in Q1 June 2023.
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