Gland Pharma’s shares increased by 3.64% on the NSE, reaching Rs 1769.90 on November 24. The surge follows the receipt of the Establishment Inspection Report (EIR) from the US FDA after inspecting Gland Pharma’s Pashamylaram facility in Hyderabad.
The inspection, conducted between August 23 and 26, focused on pre-market aspects and US FDA’s quality system, particularly the current good manufacturing practice regulations for medical devices (21 CFR Part 820).
US FDA’s requirements in 21 CFR Part 820 aim to ensure the safety, effectiveness, and compliance of finished medical devices with the Federal Food, Drug, and Cosmetic Act. Gland Pharma reported a 19.56% YoY decline in consolidated net profit for the July-September quarter, decreasing to Rs 194 crore from Rs 241.2 crore in the previous year.
Despite the profit decline, the company’s revenue witnessed a significant rise, reaching Rs 1,373.4 crore, indicating a 31.52% increase compared to last year’s Rs 1,044.4 crore.
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