Gland Pharma witnessed a notable uptick of 3.64 percent in its shares on the NSE, trading at Rs 1769.90 at 10:57 am on November 24. This surge came in the wake of the drug maker securing the Establishment Inspection Report (EIR) from the US Food and Drug Administration (US FDA), following a thorough inspection at its Pashamylaram facility in Hyderabad.
The inspection, conducted from August 23 to 26, focused on pre-market aspects, encompassing the US FDA’s quality system and current good manufacturing practice regulations for medical devices (21 CFR Part 820).
As outlined by the regulator, the requirements in this section are designed to ensure the safety, effectiveness, and overall compliance of finished devices with the Federal Food, Drug, and Cosmetic Act. These regulations establish fundamental criteria applicable to manufacturers of finished medical devices.
As of 11:52 am, Gland Pharma’s shares continued their positive momentum, trading 2.96% higher at ₹1,758.35.
