| |DECEMBER 20259PIRAMAL PHARMA GETS FDA FORM 483 AFTER LEXINGTON SITE INSPECTIONLUPIN'S LMS & POLYPEPTIDE FORM ALLIANCE TO STRENGTHEN PEPTIDE SUPPLYLupin Manufacturing Solutions (LMS), a subsidiary of Lupin Limited, announced a major strategic alliance today with PolyPeptide Group AG, marking a significant move in the expanding peptide market.The long-term partnership aims to build a stronger, more reliable supply chain for peptide-based active pharmaceutical ingredients as demand accelerates worldwide, especially in metabolic disease therapies.The collaboration focuses on expanding sourcing options, tightening procurement and supply planning, and ensuring dependable, high-quality peptide production across global markets. By joining forces, both companies expect to raise operational efficiency and strengthen readiness for next-generation peptide therapeutics.For LMS, this alliance supports its vision of becoming a leading CDMO partner for both innovator and generic peptide materials. For PolyPeptide, it reinforces its position as a trusted supplier with deeper supply chain flexibility and capacity to manage growing commercial demand.Dr. Abdelaziz Toumi, Chief Executive Officer, Lupin Manufacturing Solutions, said, "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 specialized materials that support large-scale commercial production. This underscores our mission to establish secure, agile, and future-ready supply pathways for innovators worldwide."Stephane Varray, Chief Commercial Officer, PolyPep-tide, added, "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 prepara-tions for large-scale metabolics. When you're enabling life-changing therapies, your supply chain must operate as a true strategic capability." POPiramal Pharma drew attention today as the US FDA wrapped up a general Good Manufacturing Practices inspection at the company's Lexington, Kentucky site.The review, held from December 3 to December 10, 2025, ended with a Form 483 containing four observations. These points focus on procedural improvements and are expected to fall under the Voluntary Action Indicated (VAI) category, a sign that the regulator sees the issues as correctable without major enforcement.The company said it is preparing a detailed response within the required timeline and stressed that it remains committed to strong compliance standards. Piramal Pharma noted it will continue working with the regulator to address every point raised during the inspection.As a global healthcare player, Piramal Pharma operates 17 manufacturing sites and distributes products across more than 100 countries. Its business includes Piramal Pharma Solutions, a full-scale Contract Development and Manufacturing Organization; Piramal Critical Care, which focuses on complex hospital generics; and the India Consumer Healthcare division, known for its over-the-counter brands.Financial performance, however, has been under pressure. The company posted a consolidated net loss of Rs 99.22 crore in Q2 FY26, a sharp turn from the Rs 22.59 crore profit reported in the same quarter last year. Revenue declined 8.83% YoY to Rs 2,043.72 crore, reflecting softer demand across key segments.Despite the challenging quarter and the FDA's latest feedback, Piramal Pharma emphasized that it remains focused on operational discipline and quality systems as it works to stabilize performance and maintain trust within the global pharmaceutical industry. PO
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