Glenmark Pharmaceuticals Receives EIR for Monroe Facility
Filing Summary
Glenmark Pharmaceuticals Ltd has received an Establishment Inspection Report (EIR) with a Voluntary Action Indicated (VAI) status from the U.S. Food and Drug Administration (FDA) for its Monroe, North Carolina facility. The inspection occurred from June 9 to June 17, 2025. The facility was previously under a Warning Letter since June 2023. Following the EIR, commercial manufacturing at the Monroe site will restart. Glenmark had earlier reported a Form-483 with five observations post-inspection in June 2025.
On November 27, 2025, Glenmark Pharmaceuticals Ltd announced the receipt of an Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (FDA) for its formulations manufacturing facility located in Monroe, North Carolina, USA. The report was issued with a Voluntary Action Indicated (VAI) status following an inspection conducted from June 9 to June 17, 2025.
The Monroe facility had been under a Warning Letter since June 2023. The company had previously informed the stock exchange on June 18, 2025, about receiving a Form-483 with five observations related to the inspection conducted in June 2025. With the receipt of the EIR, Glenmark will now restart commercial manufacturing operations at the Monroe site.
The EIR indicates that the FDA has reviewed the corrective actions taken by Glenmark in response to the observations noted in the Form-483. The VAI status suggests that while the FDA has identified issues, they do not warrant further regulatory action at this time. The resumption of manufacturing activities marks a significant step for the Monroe facility.
Glenmark Pharmaceuticals Ltd is a research-led, global pharmaceutical company. It operates across branded, generics, and OTC segments, focusing on therapeutic areas such as respiratory, dermatology, and oncology. The company has 11 manufacturing facilities across four continents and operates in over 80 countries. Glenmark’s commitment to reducing greenhouse gas emissions has been recognized by the Science Based Target initiative, making it one of the few pharmaceutical companies in India to achieve this approval.