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Shilpa Medicare slips after US FDA issues four form 483 obersvations to Bengaluru facility
31-Oct-24   13:43 Hrs IST

In a regulatory filing made during market hours today, the company informed the company's Unit- VI, Dabaspet, Bengaluru, India, was inspected by USFDA on 24, 25 and 28, 29, 30 October 2024. The inspection was the onsite GMP inspection of this site.

The inspection concluded with the issuance of Form 483 with four observations. All observations are procedural in nature. 'The company shall respond to the observations within the time frame,' Shilpa Medicare said.

This unit of Shilpa Medicare is engaged in the manufacturing, testing and release of oral mouth dissolving films and transdermal systems.

The site has already been approved by MHRA-UK and TGA Australia and has US FDA approval for supplying nutraceutical oral film products into US and other markets.

Raichur-based Shilpa Medicare is a vertically integrated, manufacturer and distributor of quality drugs to global markets; specializing in the oncology therapeutic segment and introducing novel drugs focusing on patient convenience and compliance.

The company reported consolidated net profit of Rs 14.06 crore in Q1 FY25, steeply higher than Rs 1.18 crore posted in Q1 FY24. Revenue from operations grew by 12.4% YoY to Rs 292.51 crore in the quarter ended 30 June 2024.

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