Gland Pharma Secures EIR From USFDA for Pashamylaram Facility

Gland Pharma, a leading injectable-focused pharmaceutical company, operates across 60 countries, including the U.S., Europe, Canada, Australia, and India. Its diverse portfolio features vials, ampoules, pre-filled syringes, lyophilised vials, dry powders, infusions, and specialised oncology and ophthalmology solutions, showcasing its global impact and innovation in healthcare.

Got EIR from USFDA

Gland Pharma recently announced the receipt of an Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) for its Pashamylaram facility in Hyderabad. 

The issuance of the EIR signifies the successful closure of the inspection, which was conducted between 25th July and 2nd August 2024. During this period, the USFDA reviewed the site’s adherence to Good Manufacturing Practices (GMP) and issued three procedural Form 483 observations.

Gland Pharma Q2 FY25 Results

Gland Pharma reported a 15.7% year-on-year decline in net profit, amounting to ₹163.5 crore for Q2 FY25, attributed largely to diminished European sales and operational hurdles at its French subsidiary, Cenexi. However, the company witnessed a modest 2.4% growth in revenue from operations, reaching ₹1,405.83 crore. This growth was propelled by a 3% uptick in U.S. sales and an impressive 45% surge in other international markets.

EBITDA for the quarter contracted by 8% to ₹297.06 crore, with margins narrowing to 21.1% from 23.6% in the prior year. Research and development (R&D) expenditure totalled ₹49.3 crore, accounting for 4.6% of revenue. During the quarter, Gland Pharma filed 7 new Abbreviated New Drug Applications (ANDAs) and secured eight approvals, underscoring its commitment to innovation.

Share Price Performance 

At 3:30 PM today, Gland Pharma share price traded at ₹1,670.00 per share on the NSE.

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