Glenmark Pharma shares rise nearly after getting EIR from USFDA for North Carolina unit

Shares of Glenmark Pharmaceuticals rose as much 1.91% to hit an intraday high of ₹1,958 on the National Stock Exchange on Thursday, November 27. On the BSE, Glenmark Pharmaceuticals shares advanced as much as 1.92% after the company informed exchanges that it received an Establishment Inspection Report (EIR) from the United States Food & Drug Administration (US FDA).

Glenmark Pharma in a regulatory filing said that it received an EIR from the US FDA with a Voluntary Action Indicated (VAI) status from the US FDA for its formulations manufacturing facility situated in Monroe, North Carolina, USA.

Glenmark Pharma said that the EIR came after US FDA conducted an inspection from June 9-17, 2025, and the company will restart commercial manufacturing at the Monroe facility.

The company had earlier informed the stock exchange (BSE) on 18 June 2025 about the Form-483 with five observations for the above June 2025 inspection. The site was earlier under Warning Letter since June 2023, Glenmark added.

Earlier this week, Glenmark Pharma launched the world's first nebulised, fixed-dose triple therapy for the treatment of chronic obstructive pulmonary disease.

It launched Nebzmart GFB Smartules and Airz FB Smartules, which combine three proven medicines, including Glycopyrronium, Formoterol, and Budesonide, to reduce airway obstruction, inflammation, and improve lung function and symptom control, it said.

As a single, easy-to-use nebulised therapy, it minimises the burden of multiple medications, it added.

This marks a breakthrough as a new standard of care for COPD patients, especially those who struggle with using metered dose inhalers or dry powder inhalers, the Mumbai-based company stated.

About Glenmark Pharma

Glenmark Pharmaceuticals is a research‐led, global pharmaceutical company, having a presence across Branded, Generics, and OTC segments; with a focus on therapeutic areas of respiratory, dermatology and oncology. The company has 11 manufacturing facilities spread across four continents and operations in over 80 countries.

As of 11:47 am, Glenmark Pharma shares traded 0.87% higher at ₹1,938, NIFTY50 index which was up 0.23%.