Gland Pharma Surges 3.6% as US FDA Concludes Inspection at Hyderabad Facility

Gland Pharma Surges 3.6% as US FDA Concludes Inspection at Hyderabad Facility

The inspection took place from August 23, 2023, to August 26, 2023.

Gland Pharma’s shares traded 3.64 percent higher on the NSE, reaching Rs 1769.90 at 10:57 am on November 24. This surge followed the drug maker’s receipt of the Establishment Inspection Report (EIR) from the US Food and Drug Administration (US FDA) after an inspection at its Pashamylaram facility in Hyderabad.

The inspection, conducted between August 23 and 26, focused on the US FDA’s quality system and current good manufacturing practice regulations for medical devices (21 CFR Part 820).

These regulations are designed to ensure the safety and effectiveness of finished devices, in compliance with the Federal Food, Drug, and Cosmetic Act. They establish fundamental requirements applicable to manufacturers of finished medical devices.

Gland Pharma had previously reported a 19.56 percent year-on-year fall in consolidated net profit to Rs 194 crore for the July-September quarter of the current financial year, compared to Rs 241.2 crore the previous year. However, its revenue saw a significant increase, reaching Rs 1,373.4 crore, up by 31.52 percent from the previous year’s Rs 1,044.4 crore.

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