Gland Pharma surges 3.6% after US FDA inspection at Hyderabad facility

Gland Pharma shares surged by 3.64% on the NSE to reach Rs 1769.90 at 10:57 am on November 24, following the receipt of the Establishment Inspection Report (EIR) from the US Food and Drug Administration (US FDA). The inspection, conducted at its Pashamylaram facility in Hyderabad, took place from August 23 to 26. The inspection was a pre-market assessment focusing on the US FDA’s quality system and current good manufacturing practice regulations for medical devices (21 CFR Part 820).

The specific requirements outlined in this part of the regulations are designed to ensure that finished medical devices are safe, effective, and compliant with the Federal Food, Drug, and Cosmetic Act. The act establishes fundamental requirements applicable to manufacturers of finished medical devices.

This positive development comes after the company reported a 19.56% year-on-year decline in consolidated net profit to Rs 194 crore for the July-September quarter of the current financial year, compared to Rs 241.2 crore in the previous year. However, Gland Pharma's revenue showed a robust growth of 31.52%, reaching Rs 1,373.4 crore, up from Rs 1,044.4 crore in the corresponding period last year. The successful conclusion of the US FDA inspection at its Hyderabad plant is expected to have a favorable impact on Gland Pharma's market performance.

Please note that the information provided is based on the available data and news reports as of November 24, 2023.