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The US drug regulator conducted a pre-market inspection covering its quality system/current good manufacturing practice regulations for medical devices (21 CFR Part 820) at the company's Pashamylaram Facility at Hyderabad from 23 August 2023 to 26 August 2023.
The inspection concluded with two observations on Form 483 with respect to ANDA filed for the product to be manufactured in a PEN device. There is no data integrity observation, said the company.
The pharmaco also added that it is committed to address the observations and will submit its response to US FDA within the stipulated time.
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. It has a wide range of injectables, including vials, ampoules, pre-filled syringes, lyophilized vials, dry powders, infusions, oncology, and ophthalmic solutions and also enjoys the distinction of having pioneered Heparin technology in India.
The company's consolidated net profit declined 15.3% to Rs 194.10 crore despite of 41.1% jump in revenue to Rs 1,208.69 crore in Q1 FY24 over Q1 FY23.
Shares of Gland Pharma rose 2.23% to Rs 1,580.85 on the BSE.
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