India Pharma Outlook Team | Friday, 17 January 2025
Gland Pharma announced that it has secured the establishment inspection report (EIR) from the US drug regulatory authority for its Dundigal site in Hyderabad, marking the conclusion of the inspection. The US Food and Drug Administration (USFDA) carried out an unannounced inspection of the company's Dundigal Facility for good manufacturing practices (GMP) from 22 July 2024 to 25 July 2024.
Previously, on 25 July, the drug manufacturer announced that the inspection had finished with 2,483 observations. These observations were procedural and were not repeated observations or connected to data integrity. The company has now obtained an EIR from the USFDA indicating the conclusion of the inspection.
Gland Pharma ranks among the largest and rapidly advancing companies specializing in injectables, having a presence in 60 countries worldwide, such as the United States, Europe, Canada, Australia, India, and various other markets. It offers a diverse selection of injectables, comprising vials, ampoules, pre-filled syringes, freeze-dried vials, dry powders, infusions, oncology treatments, and ophthalmic solutions. The firm also led the way in Heparin technology within India.
On a consolidated level, the company's net profit fell by 15.74% to Rs 163.53 crore, even with a 2.36% rise in operational revenue to Rs 1,405.83 crore in Q2 FY25 compared to Q2 FY24. The stock increased by 0.24% and is presently trading at Rs 1,676.75 on the BSE.
The Food and Drug Administration of the United States (FDA or US FDA) is a federal agency within the Department of Health and Human Services. The main priority of the FDA is to enforce the Federal Food, Drug, and Cosmetic Act (FD&C). Nonetheless, the agency additionally implements various laws, particularly Section 361 of the Public Health Service Act along with related regulations.
, CDSCO.jpg)
