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Gland Pharma's Visakhapatnam API unit undergoes routine inspection by USFDA

Gland Pharma's Visakhapatnam API unit undergoes routine inspection by USFDA

Gland Pharma's Visakhapatnam API unit undergoes routine inspection by USFDA
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By Ekta Batra  Jan 23, 2023 2:48:39 PM IST (Published)

In a statement to CNBC-TV18, a spokesperson for Gland Pharma said that the inspection started on Monday, and is a routine process carried out by the USFDA to ensure compliance with manufacturing standards and regulations. This will cover all aspects of the facility's operations, including manufacturing processes, quality control, and documentation.

Gland Pharma, a leading pharmaceutical company based in India, has confirmed that the United States Food and Drug Administration (USFDA) has begun a routine inspection of its Active Pharmaceutical Ingredient (API) unit located in Visakhapatnam, India.

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In a statement to CNBC-TV18, a spokesperson for Gland Pharma said that the inspection started on Monday, and is a routine process carried out by the USFDA to ensure compliance with manufacturing standards and regulations. This will cover all aspects of the facility's operations, including manufacturing processes, quality control, and documentation.
The shares of Gland Pharma are trading 0.63 percent lower at Rs 1377 at this hour.
Gland Pharma reported a 15 percent drop in consolidated net profit to Rs 231.95 crore for the third quarter ended December 2022, owing to manufacturing delays caused by supplier interruptions.
It reported a consolidated net profit of Rs 273.03 crore in the same period last year, according to a regulatory filing. Consolidated revenue from operations was Rs 938.29 crore in the quarter under review, compared to Rs 1,063.33 crore the previous year.
Total expenses in the third quarter were Rs 688.95 crore, down from Rs 743.43 crore in the same period last year.
"Challenging business environment, ongoing supply chain disruptions leading to production delays continue to impact our performance," Gland Pharma Managing Director and CEO Srinivas Sadu said.
Gland Pharma said that the company's key markets of the United States, Europe, Canada, Australia, and New Zealand contributed for 70 percent of sales during the quarter, maintaining a similar level of revenue contribution as in Q3 FY22.
The global markets contributed 21 percent, while the Indian market accounted for 9 percnt of Q3 FY23 revenue, which saw a sequential rebound owing to the normalisation of the insulin manufacturing line, it added.
Total R&D expense was Rs 51.2 crore during the quarter, accounting for 5.5 percent of revenue, the company said, adding that total capex was Rs 42.7 crore.
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