Senores Pharmaceuticals announced that its material subsidiary, Havix Group Inc. D/B/A Aavis Pharmaceuticals ("Havix"), has successfully completed a United States Food & Drug Administration (USFDA) inspection at its manufacturing facility in Hoschton, Georgia, USA.

Inspection Details

The USFDA inspection took place from July 21 to July 25, 2025, at Havix's facility located at 9488 Jackson Trail Road, Hoschton, Georgia. The inspection concluded with three Form 483 observations, which the company described as procedural and minor in nature.

Company Response

Havix has been given a 15-day window to respond to these observations from the regulatory authority. The company has confirmed its intention to address these issues within the stipulated timeframe.

Management Statement

In a regulatory filing, Vinay Kumar Mishra, Company Secretary and Compliance Officer of Senores Pharmaceuticals Limited, stated, "These observations are procedural and minor in nature and Havix will respond to these observations within 15 days."

About Senores Pharmaceuticals

Senores Pharmaceuticals Limited is headquartered in Ahmedabad, Gujarat, India. The company, with its material subsidiary Havix, operates in the pharmaceutical sector. Havix's manufacturing facility in the United States plays a crucial role in the company's operations and regulatory compliance.

This USFDA inspection and its outcome are significant for Senores Pharmaceuticals and its subsidiary, as they reflect on the company's manufacturing practices and regulatory standing in the important US market.

Investors and stakeholders will likely be watching closely for any updates on the company's response to the USFDA observations and any potential impact on its operations or market position.

Senores Pharmaceuticals , a global research-driven pharmaceutical company, has announced impressive financial results for the first quarter of fiscal year 2026, demonstrating strong growth across key metrics.

Financial Highlights

The company reported a consolidated total income of Rs 138.00 crores for Q1 FY26, marking a substantial 72% year-on-year growth. This performance was driven by significant improvements in both regulated and emerging markets.

• EBITDA: Rs 34.20 crores, up 60% year-on-year
• Profit After Tax (PAT): Rs 21.20 crores, representing a 95% year-on-year increase

Segment Performance

Regulated Markets

• Revenue: Rs 90.10 crores, up 69% year-on-year
• Contribution: 65% of total revenue

Branded Generics

• Revenue: Rs 8.20 crores, showing exceptional growth of 358% year-on-year

Operational Highlights

• Received ANDA approval for 4 products
• Commercialized 2 products
• Launched 5 new products during the quarter
• Positive operating cash flow of Rs 11.00 crores
• Increased stake in subsidiary Havix to 73% from 66.6% in December 2024

Product Portfolio

• Operates across 40+ countries
• 308 approved products in emerging markets
• 70 approved ANDA products in regulated markets

Manufacturing Facilities

Senores Pharmaceuticals maintains manufacturing facilities in:

• Atlanta, US
• Ahmedabad, India

These facilities serve both regulated and emerging markets.

With its strong Q1 performance and strategic initiatives, Senores Pharmaceuticals appears well-positioned for continued growth in the pharmaceutical sector.