Lupin has received Establishment Inspection Report (EIR) approval from the US Food and Drug Administration (FDA) for its injectable manufacturing facility located in Nagpur. This regulatory milestone represents a significant achievement for the pharmaceutical company's manufacturing operations and compliance standards.

Regulatory Approval Details

The EIR approval from the US FDA confirms that Lupin's Nagpur injectable plant has successfully met the stringent regulatory requirements and quality standards mandated for pharmaceutical manufacturing facilities. An Establishment Inspection Report is issued by the FDA following a comprehensive inspection of manufacturing facilities to ensure compliance with current Good Manufacturing Practices (cGMP) and other regulatory standards.

Manufacturing Facility Significance

The Nagpur injectable manufacturing facility represents an important component of Lupin's production infrastructure. Injectable medications require specialized manufacturing processes and stringent quality controls due to their direct administration into patients' bodies. The FDA approval validates the facility's adherence to these critical manufacturing standards.

Regulatory Compliance Impact

Receiving EIR approval demonstrates Lupin's commitment to maintaining high-quality manufacturing standards across its facilities. This regulatory clearance is essential for pharmaceutical companies operating in the US market, as it ensures that manufacturing processes meet the FDA's rigorous safety and quality requirements for injectable drug products.

The EIR approval marks a regulatory compliance milestone for Lupin, further strengthening its position in the pharmaceutical industry and potentially opening up new opportunities for the company in the US market.

Lupin Manufacturing Solutions (LMS), a subsidiary of global pharma major Lupin Limited, has announced a long-term strategic alliance with PolyPeptide Group AG, a specialized global CDMO for peptide-based active pharmaceutical ingredients. The collaboration, announced on December 12, 2025, aims to enhance supply chain resilience, improve operational efficiency, and accelerate readiness for the rapidly expanding global peptides market.

Strategic Alliance Framework

The partnership between LMS and PolyPeptide focuses on comprehensive supply chain enhancement and market expansion. Key objectives of the alliance include expanding sourcing options and fortifying peptide supply chains to meet rising global demand for peptide APIs, integrating procurement and supply planning, and ensuring unwavering quality and reliability while delivering superior service globally.

Executive Leadership Perspectives

Dr. Abdelaziz Toumi, Chief Executive Officer of Lupin Manufacturing Solutions, emphasized the strategic importance of the alliance: "We are delighted to announce our strategic alliance with PolyPeptide. As peptide-based therapies continue to transform the treatment landscape for metabolic and other chronic conditions, LMS is committed to ensuring reliable access to specialised materials that support large-scale commercial production."

Stephane Varray, Chief Commercial Officer at PolyPeptide, highlighted the operational benefits: "Reliability is a competitive advantage in our industry. Working with Lupin Manufacturing Solutions gives us the flexibility and supply chain depth needed to support growing customer demand, including preparations for large-scale metabolics."

Market Positioning and Impact

This partnership strengthens LMS as a leading CDMO supplier of peptide materials for both innovator and generic markets, while enhancing PolyPeptide's position as a trusted CDMO partner. The alliance addresses the critical need for reliable and scalable peptide manufacturing capabilities in the fast-growing peptide therapeutics market, with significant exposure to metabolic diseases including GLP-1 therapies.

Industry Significance

The peptide therapeutics market continues experiencing substantial growth, driven by increasing applications in metabolic diseases and other therapeutic areas. PolyPeptide, with operations dating back to 1952, runs a global network of six GMP-certified facilities in Europe, the U.S., and India. LMS leverages Lupin's legacy of scientific rigor and regulatory expertise, supporting biopharma innovators with a team of 250 scientists and state-of-the-art facilities.