Strides Pharma Science has successfully completed a routine US-FDA inspection at its formulations facility operated by Strides Pharma Inc. (SPI), a step-down wholly owned subsidiary. The inspection was conducted at the Chestnut Ridge, New York facility from December 17, 2025 to December 23, 2025.

Inspection Details and Regulatory Outcome

The United States Food and Drug Administration conducted a routine current Good Manufacturing Practices (cGMP) inspection at the company's formulations facility in New York. The inspection concluded with the issuance of Form 483 containing four observations that are procedural in nature and are not expected to impact the supply of commercial products.

Strides Pharma Inc. will respond comprehensively to the FDA observations within the stipulated timeframe and expressed confidence in addressing all observations to the satisfaction of the US-FDA.

Strong Q2 Financial Performance

Strides Pharma Science reported robust financial results for the second quarter, demonstrating strong operational performance alongside regulatory compliance. The company delivered significant growth across key financial metrics.

Market Performance and Outlook

Despite the strong quarterly results, shares of Strides Pharma Science ended lower by 3.59% at ₹936.00 on December 24. The company has committed to keeping stock exchanges informed of any further updates regarding regulatory matters, demonstrating transparency in its compliance processes.

The completion of this routine FDA inspection represents an important regulatory milestone for the company's US operations, while the strong financial performance underscores the company's operational efficiency and market position in the pharmaceutical sector.

Strides Pharma Science Limited has reported strong financial results for the second quarter of fiscal year 2026, demonstrating consistent execution and sustainable growth across key metrics.

Financial Highlights

• Revenue grew by 4.6% year-on-year
• Gross margins expanded by 14.6%
• EBITDA surged by 25.4%
• Achieved highest ever quarterly operational PAT of INR 140.00 crores, representing 84% growth

For the first half of FY26, the company reported:

• Revenue increase of 5.5%
• EBITDA growth of 20%
• Gross margin of 59%
• Operational PAT of INR 254.00 crores

Market Performance

U.S. Market

• Generated $73 million in revenue with 2% growth despite intense competition
• Launched 3 products in H1 FY26
• Maintained top-three rankings in 37 products, contributing 75% of U.S. revenue
• Total commercialized products stood at 70

Other Regulated Markets

• Showed strong 16% year-on-year growth
• Reached a significant threshold of INR 10.30 billion (over INR 1,000 crores) in revenue

Growth Markets

• Revenue at $17 million, grew 7% year-on-year

Operational Efficiency

• Gross margins improved to 57.80% for the quarter and 59% for the half-year
• Net debt reduced by INR 73.00 crores to INR 1,449.00 crores
• EBITDA to net debt ratio improved to 1.65x from 1.9x
• Operational cash of INR 394.00 crores for H1, with 87% EBITDA to operational cash conversion
• ROCE improved to 16% compared to 14.9% in March 2025

Strategic Focus

Strides Pharma continues to focus on:

1. Profitability over revenue growth
2. Maintaining disciplined capital allocation
3. Service level excellence
4. Long-term sustainable business with EPS accretion

The company maintains its target of $400 million in U.S. revenue by FY28 and expects other regulated markets plus growth markets to mirror U.S. performance within 2-3 years.

R&D and Future Growth

• Investing in new segments such as Control Substances
• Focusing on Nasal Sprays and Beyond Generics initiatives
• Filed one product in Nasal Sprays category, with plans to file more in the next 12 months
• R&D spend expected to be between $15 million to $20 million for the year

Management Commentary

Badree Komandur, Managing Director and Group CEO, stated, "Our performance demonstrates our consistent execution as we invest in sustainable long-term growth. We are focusing on long-term sustainable business with EPS accretion."

Vikesh Kumar, Group CFO, added, "It has been a comprehensive performance across metrics, and that is clearly visible, both in the profitability and the strength of our balance sheet. We hope to continue and sustain this momentum as we focus on our growth levers for the future."

The management emphasized that while there are near-term headwinds in certain markets, their long-term outlook remains intact, with a focus on profitable expansion and continuous cost improvement to maintain market leadership positions.