Gland Pharma said that the United States Food and Drug Administration (US FDA) had conducted a pre-market inspection at the company's Dundigal facility at Hyderabad from 22 to 25 August 2022.
The inspection covered US FDA's quality system/current good manufacturing practice regulations for medical devices. The inspection was done
The company has received 1 (ONE) observation on Form 483 with respect to ANDA filed for the product to be manufactured at the said Facility. There is no data integrity observation.
"The company is committed to address the observation and will submit its response to US FDA within the stipulated time, Gland Pharma said in a statement.
Hyderabad-based 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. It operates primarily under a business to business (B2B) model and it engaged in development, manufacturing and marketing of complex injectables.
The company's consolidated net profit tumbled 35% to Rs 229.2 crore on 26% decline in revenue from operations to Rs 856.9 crore in Q1 FY23 over Q1 FY22.
The scrip shed 0.21% to currently trade at Rs 2397.95 on the BSE.
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