Lupin Limited , a global pharmaceutical leader, has announced a significant milestone in its quality assurance efforts. The company's Nagpur Unit-1 oral solid dosage manufacturing facility successfully completed a product-specific Pre-Approval Inspection by the U.S. Food and Drug Administration (FDA) with zero 483 observations.

Inspection Details

The inspection, which took place from November 10 to November 14, focused on the facility's compliance with FDA regulations. The outcome demonstrates Lupin's commitment to maintaining high standards of quality, compliance, and safety across its manufacturing facilities.

Management's Perspective

Nilesh Gupta, Managing Director of Lupin, expressed his satisfaction with the inspection results, stating, "The successful outcome of the U.S. FDA inspection at our Nagpur Unit-1 facility exemplifies our commitment to uphold and maintain the highest standards of quality, compliance, and safety across our facilities. We remain dedicated to improving the lives of our patients globally."

Implications for Lupin

This successful inspection is a positive development for Lupin, as it:

1. Reinforces the company's reputation for quality and compliance
2. Potentially streamlines future product approvals for this facility
3. Demonstrates Lupin's ability to meet stringent regulatory standards

About Lupin Limited

Lupin Limited is a prominent player in the global pharmaceutical industry, with a presence in over 100 markets. The company specializes in:

• Branded and generic formulations
• Complex generics
• Biotechnology products
• Active pharmaceutical ingredients

Lupin has established a strong position in India and the U.S. across multiple therapy areas, including:

• Respiratory
• Cardiovascular
• Anti-diabetic
• Anti-infective
• Gastrointestinal
• Central nervous system
• Women's health

With 15 state-of-the-art manufacturing sites and 7 research centers globally, Lupin employs over 24,000 professionals. The company is committed to improving patient health outcomes through its subsidiaries: Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions.

This successful FDA inspection underscores Lupin's ongoing commitment to quality and positions the company well for continued growth in the competitive pharmaceutical market.

Lupin Limited , a global pharmaceutical leader, has made a significant stride in the U.S. market with the launch of Risperidone Long-Acting Injectable. This antipsychotic medication comes with a 180-day Competitive Generic Therapy (CGT) exclusivity, positioning Lupin at a competitive advantage in the market.

Key Highlights of the Launch

• Product: Risperidone for extended-release injectable suspension
• Dosages: 25 mg, 37.5 mg, and 50 mg per vial (Single-Dose Vials)
• Market: United States
• Exclusivity: 180-day CGT exclusivity
• Technology Platform: PrecisionSphere™ (Lupin's proprietary long-acting injectable platform)

Significance of the Launch

This launch marks a pivotal moment for Lupin, as it represents the first commercial product utilizing their PrecisionSphere™ technology. Developed by Lupin's subsidiary Nanomi B.V., this long-acting injectable (LAI) platform showcases the company's growing capabilities in specialized drug delivery systems.

Spiro Gavaris, President of U.S. Generics at Lupin, emphasized the importance of this launch, stating, "It highlights our commitment to expanding our portfolio of differentiated, complex products, marking a significant step forward in our pursuit of developing novel long-acting injectables across diverse therapeutic areas."

PrecisionSphere™ Technology

The PrecisionSphere™ platform offers several advantages:

• Creation of uniform microspheres
• Extended-release profiles ranging from weeks to months
• Superior injectability through smaller needles
• Consistent drug concentrations

These features potentially enhance patient compliance and treatment efficacy, particularly crucial for medications treating conditions like schizophrenia and bipolar disorder.

Market Potential

The launch taps into a substantial market opportunity. According to IQVIA data, the estimated sales for Risperidone for extended-release injectable suspension (referencing Risperdal Consta®) in the U.S. were approximately USD 187.00 million for the 25 mg, 37.5 mg, and 50 mg doses combined (MAT September 2025).

Strategic Implications

Dr. Fabrice Egros, President of Corporate Development at Lupin, highlighted the strategic importance of this launch, noting, "PrecisionSphere's proven capabilities, combined with our track record of successful partnerships, uniquely position us to expand global access to advanced long-acting injectable treatments."

Lupin is actively seeking to leverage this technology beyond its internal pipeline, exploring potential collaborations with other companies to extend product lifecycles and expand patient access to advanced LAI treatments.

Conclusion

The successful launch of Risperidone Long-Acting Injectable in the U.S. market represents a significant milestone for Lupin. It not only demonstrates the company's growing expertise in complex injectables but also validates the capabilities of its PrecisionSphere™ technology platform. As Lupin continues to expand its portfolio and explore strategic partnerships, this launch may serve as a springboard for future growth and innovation in the pharmaceutical industry.