In a stock exchange filing, Glenmark Pharma said that it has received the Establishment Inspection Report (EIR) from the US Food and Drug Administration (USFDA) for its formulations manufacturing facility situated in Monroe
In a stock exchange filing, Glenmark Pharma said that it has received the Establishment Inspection Report (EIR) from the US Food and Drug Administration (USFDA) for its formulations manufacturing facility situated in MonroeShares of Glenmark Pharmaceuticals Ltd rose as much as 1.93 per cent to touch the day’s high of Rs 1958 in Thursday's trade over its previous close of Rs 1920.95. The stock has gained nearly 40 per cent in the last six months and has been in an upward trend for the last three sessions, including today. The surge follows a regulatory win for the company in the United States.
In a stock exchange filing, the Mumbai-headquartered drug maker said that it has received the Establishment Inspection Report (EIR) from the US Food and Drug Administration (USFDA) for its formulations manufacturing facility situated in Monroe, North Carolina, USA. The inspection was classified with a Voluntary Action Indicated (VAI) status, signalling a clearance that allows the facility to resume full operations.
“The commercial manufacturing at the Monroe site will now restart,” the company said in the regulatory filing. The inspection was conducted by the US health regulator from June 09 to June 17, 2025. This development marks a pivotal turnaround for the facility, which had been under a warning letter since June 2023. The company had previously notified exchanges on June 18, 2025, regarding a Form-483 issuance with five observations following the inspection, which have now been effectively addressed.
Earlier, Glenmark Pharma, on November 25, informed stock exchanges about a major product launch in the respiratory segment. The company announced the launch of “Nebzmart GFB Smartules and Glenmark Airz FB Smartules, the world's first nebulised, fixed-dose triple therapy for the treatment of Chronic Obstructive Pulmonary Disease (COPD).”
Brokerage firm Deven Choksey Research has a 'Buy' recommendation on the stock with a target price of Rs 2,300. In their report dated November 18, Deven Choksey noted that the company delivered an exceptional Q2 buoyed by ISB-2001 income and sharp margin expansion.
Meanwhile, Motilal Oswal Financial Services (MOFSL) also maintains a 'Buy' rating with a target price of Rs 2,170. In a note dated November 17, MOFSL highlighted that while the second quarter was tough due to a GST shock and operational reset, the outlook remains positive.
“With a coarse reset for inventory levels/debtor levels, along with continued focus on growth across key markets and the clinical development o