The US Food and Drug Administration (USFDA) conducted its pre-market inspection covering quality system/current good manufacturing practice (cGMP) regulations for medical devices at Gland Pharma's Dundigal facility in Hyderabad.
The US drug regulator had inspected the facility from 22 August 2022 to 25 August 2022. On 26 August 2022, the company received one observation on Form 483 with respect to ANDA filed for the product to be manufactured at the said facility. There was no data integrity observation.The pharma company said that it has now received Establishment Inspection Report (EIR) from the Office of Product Evaluation and Quality Center for Devices and Radiological Health, US FDA indicating closure of the inspection.
Hyderabad-based Gland Pharma has grown over the years from a contract manufacturer of small volume liquid parenteral products, to become 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.
On consolidated basis, the company's net profit declined 20.1% to Rs 241.24 crore on 3.3% decrease in net sales to Rs 1044.40 crore in Q2 FY23 over Q2 FY22.
The scrip shed 0.45% to currently trade at Rs 1,569.95 on the BSE.
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