Granules India has announced that its subsidiary Granules Life Sciences received an Establishment Inspection Report (EIR) from the US Food and Drug Administration (FDA). The company disclosed this through a regulatory filing dated December 12, following the FDA's inspection of the facility.

Inspection Details and Timeline

Granules Life Sciences Private Limited, a wholly-owned subsidiary of Granules India Limited situated in Hyderabad, received the EIR following an FDA inspection conducted from July 28 to August 1. The company had previously communicated about this development in earlier notifications dated November 11 and August 1.

Regulatory Significance

The EIR represents the FDA's formal documentation following their inspection of the manufacturing facility. This regulatory clearance confirms the facility's compliance with FDA quality standards and regulatory requirements, which is essential for pharmaceutical companies to maintain their operational status and market access in the United States.

Manufacturing Operations

Granules Life Sciences Private Limited is engaged in the manufacturing of PFI Finished Dosages. The successful completion of the FDA inspection process indicates that the facility has met the required manufacturing and quality standards for pharmaceutical operations targeting the US market.

This regulatory achievement reinforces Granules India's commitment to maintaining high standards of manufacturing and quality control across its operations, particularly in key markets like the United States where regulatory oversight is stringent. The successful FDA inspection represents an important milestone for the company's pharmaceutical manufacturing capabilities.

Granules India Limited has achieved a significant milestone in environmental sustainability by receiving the highest A rating in Climate Change from the Carbon Disclosure Project (CDP) for 2025. This achievement represents a two-level improvement from the B rating the pharmaceutical company received in 2024, positioning it among industry leaders in climate responsibility.

CDP Rating Performance

The company's 2025 CDP assessment results demonstrate performance across multiple environmental categories:

Notably, Granules India has also achieved a B rating in Water Security, marking its first disclosure in this category.

Understanding CDP Rating Framework

The Carbon Disclosure Project employs a four-tier rating system to evaluate corporate environmental performance:

• Leadership (A-/A): Represents industry leadership in environmental sustainability
• Management (B-/B): Signifies effective management of environmental impacts
• Awareness (C-/C): Reflects a level of environmental engagement
• Disclosure (D-/D): Indicates the initial stage of environmental engagement

Granules India's achievement of an A rating places the company in the Leadership category, demonstrating its approach to climate change management and environmental stewardship.

Sustainability Commitment

This recognition underscores Granules India's commitment to sustainability and climate responsibility. The company's expansion into Water Security and Forests categories for the first time, achieving B and B- ratings respectively, indicates an approach to environmental management across multiple domains.

About Carbon Disclosure Project

The Carbon Disclosure Project is a global non-profit organization that promotes transparency in environmental reporting. CDP helps companies and organizations disclose their impacts on climate change, water security, and deforestation. By providing insights through CDP ratings, the organization enables investors, companies, and stakeholders to make informed decisions and take action toward a more sustainable future.

The improved CDP rating positions Granules India as a leader in pharmaceutical industry sustainability practices and reflects the company's focus on environmental responsibility and climate action initiatives.