Glenmark Pharmaceuticals Ltd has received the Establishment Inspection Report (EIR) from the US Food and Drug Administration (US FDA) following an inspection of its formulations manufacturing facility in Goa, India. The facility has received a Voluntary Action Indicated (VAI) classification.
The US FDA inspection was conducted at Glenmark’s Goa manufacturing facility from June 22 to June 30, 2026. The EIR marks the completion of the inspection process and provides the company with the regulator’s findings following the visit. Glenmark said the Goa facility is part of its global manufacturing network supporting the company’s pharmaceutical business. The company operates manufacturing facilities and research centres across several countries and supplies products to markets worldwide
The Goa facility manufactures pharmaceutical formulations for Glenmark’s business. The site is part of the company’s manufacturing infrastructure supporting its product portfolio and international markets. The company continues to operate across regulated pharmaceutical markets, with manufacturing and quality systems designed to meet applicable regulatory requirements.
Glenmark’s portfolio includes products across branded medicines, innovative therapies, generics and consumer health. Its research and development activities focus on identifying and developing medicines in areas where there is a significant need for treatment options.
The company has also expanded its international presence through partnerships, product launches and its own commercial operations across several markets. According to Glenmark, its manufacturing and research network supports the company’s focus on providing medicines across its key therapeutic areas while maintaining quality and regulatory standards.
The US FDA’s EIR follows the inspection conducted at the Goa facility earlier this year. The VAI classification is part of the US FDA’s inspection classification system and indicates that regulatory action is not currently recommended based on the inspection findings, while the company may need to take voluntary corrective measures.
Glenmark Pharmaceuticals Ltd. (BSE: 532296 | NSE: GLENMARK) is a global research-led pharmaceutical company focused on innovation and access to medicines. Its portfolio covers branded, innovative, generic and consumer health products, with a focus on respiratory, dermatology and oncology.
Glenmark operates 11 manufacturing facilities across four continents, supported by six R&D centres, and has a commercial presence in more than 80 countries. The company is recognised among the Top 100 biopharmaceutical companies globally by pharmaceutical sales for 2024, according to Scrip 100.
