Granules Life Sciences Completes FDA Inspection With Five Procedural Observations

Granules India Limited has announced that its wholly-owned subsidiary, Granules Life Sciences Private Limited (GLS), has successfully concluded a Good Manufacturing Practices (GMP) and Prior Approval Inspection by the U.S. Food and Drug Administration (FDA). The inspection resulted in five procedural observations, with no concerns raised regarding data integrity or product safety standards.

Inspection Timeline and Scope

The FDA inspection was conducted from December 15 to 19, 2025, at the Granules Life Sciences facility located in Hyderabad (FEI: 3030495702). The inspection focused on the facility engaged in manufacturing PFI Finished Dosages, representing a comprehensive evaluation of the company's pharmaceutical manufacturing operations.

Inspection Details:	Information
Inspection Period:	December 15-19, 2025
Facility Location:	Hyderabad
FEI Number:	3030495702
Inspection Type:	GMP and Prior Approval
Manufacturing Focus:	PFI Finished Dosages

Inspection Outcome

The inspection concluded with five observations related to procedural requirements. None of these observations are associated with data integrity or product safety issues, which are among the most critical areas evaluated during pharmaceutical inspections.

Inspection Results:	Status
Total Observations:	5 procedural requirements
Data Integrity Issues:	None identified
Product Safety Concerns:	None identified
Overall Assessment:	Successful completion

Company Response and Commitment

Granules India has committed to addressing the observations promptly and will submit its response to the US FDA within the stipulated timeframe. This approach demonstrates the company's dedication to maintaining regulatory compliance and addressing any procedural improvements identified during the inspection.

Regulatory Significance

The completion of the FDA inspection with only procedural observations reflects positively on Granules Life Sciences' manufacturing standards and quality control processes. The absence of data integrity or product safety issues is particularly significant, as these areas represent core regulatory requirements that directly impact product quality and patient safety in pharmaceutical manufacturing operations.

1 Day	5 Days	1 Month	6 Months	1 Year	5 Years
-1.18%	-3.33%	+6.14%	+24.04%	-1.84%	+64.35%

Granules India has announced a board meeting scheduled for December 23, 2025, to discuss important fundraising initiatives. The pharmaceutical company will convene its board of directors to deliberate on capital raising activities through a preferential issue mechanism.

Meeting Agenda and Objectives

The primary focus of the December 23 board meeting will be to examine the proposed fundraising strategy through preferential allotment of shares. The directors will evaluate the capital requirements and assess the most suitable approach for raising funds to support the company's operational and strategic objectives.

Key Decisions Expected

During the meeting, the board is expected to make crucial decisions regarding the preferential issue, with particular attention to determining the issue price for the proposed allotment. This pricing decision will be critical for the success of the fundraising initiative and will need to balance the company's capital requirements with market conditions.

Meeting Details	Information
Date	December 23, 2025
Purpose	Fundraising Discussion
Method	Preferential Issue
Key Decision	Issue Price Determination

Preferential Issue Mechanism

The preferential issue represents a method of raising capital by allotting shares to selected investors at a predetermined price. This approach allows companies to raise funds efficiently while maintaining control over the investor base and pricing structure.

Strategic Implications

The planned fundraising initiative reflects Granules India's strategic approach to strengthening its financial position. The board's decision to pursue a preferential issue suggests a measured approach to capital raising that aims to support future growth plans and operational requirements.