Strides Pharma Science Limited announced that its subsidiary Strides Pharma Inc. (SPI) has received the USFDA Inspection Closure Report (Establishment Inspection Report – EIR) for its formulations facility located at Chestnut Ridge, New York, USA. The development marks a significant regulatory milestone for the company's U.S. operations.

Inspection Details and Timeline

The facility underwent inspection by the United States Food and Drug Administration (USFDA) from December 17, 2025 to December 23, 2025. The comprehensive inspection covered current Good Manufacturing Practices (cGMP) and included a pre-approval inspection for Drug-Device Combination capabilities, specifically covering the company's recent filing in the nasal sprays domain.

Regulatory Outcome

Based on SPI's response to the Form 483 that was issued at the conclusion of the inspection, the USFDA has classified the inspection outcome as VAI (Voluntary Action Indicated). The EIR confirms that the inspection has been officially closed, providing regulatory clearance for the facility's operations.

Facility Capabilities and Market Focus

The Chestnut Ridge facility serves the U.S. market exclusively and maintains diverse manufacturing capabilities. The facility produces liquids, gels, hormones, modified release products and controlled substances, supporting several current and future products for the U.S. market. The successful closure of this inspection, including device combinations, further strengthens the company's U.S. business and near-term growth prospects.

Strategic Significance

The inspection closure represents a crucial development for Strides' U.S. operations, particularly in expanding capabilities for drug-device combinations in the nasal sprays segment. This regulatory approval enables the company to advance its product pipeline and strengthen its position in specialized pharmaceutical manufacturing.

About Strides

Strides is a global pharmaceutical company headquartered in Bengaluru, India, listed on BSE Limited and National Stock Exchange of India Limited. The company operates manufacturing sites across India, Italy, Kenya, and the United States, focusing on "difficult to manufacture" products sold in over 100 countries. The company maintains an "in Africa for Africa" strategy and serves institutional business in donor-funded markets.

Strides remains committed to maintaining the highest standards of regulatory compliance and continues to focus on manufacturing high-quality pharmaceutical products for global markets.

Strides Pharma Science has reported impressive financial results for the third quarter, showcasing strong operational performance and business growth. The pharmaceutical company's consolidated net profit demonstrated remarkable improvement compared to the same period in the previous year.

Financial Performance Highlights

The company's third quarter financial results reflect substantial growth across key profitability metrics. The consolidated net profit figures indicate robust business execution and effective cost management strategies.

Strong Profit Growth

The year-on-year comparison reveals exceptional performance improvement, with consolidated net profit increasing from ₹880 million to ₹2 billion. This represents a growth rate of approximately 127%, indicating significant enhancement in the company's profitability and operational efficiency.

The substantial profit increase reflects the company's ability to leverage its pharmaceutical operations effectively and capitalize on market opportunities. Such strong financial performance demonstrates management's successful execution of business strategies and operational excellence initiatives.

Business Momentum

The impressive financial results underscore Strides Pharma Science's strengthened market position and improved business fundamentals. The significant profit growth indicates the company's enhanced capability to generate sustainable returns and create value for stakeholders through its pharmaceutical business operations.