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The Hyderabad-based pharmaceutical company has announced the receipt of an Establishment Inspection Report (EIR) for its Pashamylaram Facility in Hyderabad from the USFDA. This follows Pre-Market Inspection conducted from 23 August 2023 till 26 August 2023, which focused on US FDA’s Quality System and Current Good Manufacturing Practice regulations for Medical Devices (21 CFR Part 820).
The issuance of the EIR marks the completion of the inspection, signifying that the FDA has determined the facility to be in compliance with the specified regulations.
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 has a wide range of injectables, including vials, ampoules, pre-filled syringes, lyophilized vials, dry powders, infusions, oncology, and ophthalmic solutions. The company also pioneered Heparin technology in India.
Gland Pharma reported 19.55% fall in consolidated net profit to Rs 194.08 crore in Q2 FY24 from Rs 241.24 crore in Q2 FY23. Revenue from operations jumped 31.50% to Rs 1,373.42 crore in Q2 FY24 as against Rs 1,044.40 crore recorded in Q2 FY23.
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