Onesource Specialty Pharma Ltd

Xbrane Biopharma AB is a biotechnology company. It develops biological drugs based on a patented platform technology that provides significantly lower production costs compared to competing systems. Xbrane has a portfolio of biosimilar candidates targeting EUR 23 billion in estimated annual peak sales of the respective reference product. The lead candidate Ximluci (a ranibizumab biosimilar) is granted market authorization approval in Europe (launched in 2023) and is now under the approval process for the U.S. launch. As part of the agreement, Xbrane will tech transfer its select product(s) to OneSource's integrated drug substance and drug product (DS/DP) facility in Bangalore, India. The collaboration aims to strengthen Xbrane's global supply chain, while enabling OneSource to accelerate regulatory approvals, including from the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA), for its biologics drug substance facility. As part of the collaboration, OneSource has also participated in Xbrane's latest funding round, reinforcing the long-term alignment between the two companies. Neeraj Sharma, managing director & CEO of OneSource Specialty Pharma, said: 'The partnership with Xbrane reflects our shared ambition to drive broader access to cutting-edge biologics worldwide. Xbrane's proven success in biosimilar development, combined with OneSource's fully integrated biologics platform, creates a strong platform for global impact. We are pleased to support the scale-up of high-quality biosimilars and advance our vision of being a trusted partner to the world's leading biotech companies.' OneSource Specialty Pharma is a pure-play specialty pharmaceutical CDMO. The company focuses on the development and manufacturing of complex pharmaceutical products including biologics, drug-device combinations, sterile injectables, and oral technologies (soft gelatine capsules). It has five manufacturing facilities approved by global regulatory authorities and a dedicated team of over 1,200 professionals. On a consolidated basis, OneSource Specialty Pharma reported net profit of Rs 98.50 crore in Q4 March 2025 as against net loss of Rs 40.17 crore in Q4 March 2024. Net sales surged 482.38% YoY to Rs 425.95 crore in Q4 March 2025. Powered by Capital Market - Live

OneSource Specialty Pharma and Xbrane Biopharma AB, a Sweden-headquartered biotechnology company, today announced a partnership focused on the commercial manufacturing of Xbrane's biosimilar portfolio. Xbrane has a portfolio of biosimilar candidates targeting EUR 23 billion in estimated annual peak sales of the respective reference products. The lead candidate Ximluci (a ranibizumab biosimilar) is granted market authorization approval in Europe (launched in 2023) and is now under the approval process for the U.S. launch. As part of the agreement, Xbrane will tech transfer its select product(s) to OneSource's state-of the-art integrated Drug Substance and Drug Product (DS/DP) facility in Bangalore, India. The collaboration aims to strengthen Xbrane's global supply chain, while enabling OneSource to accelerate regulatory approvals, including from the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA), for its biologics drug substance facility. As part of the collaboration, OneSource has also participated in Xbrane's latest funding round, reinforcing the long-term alignment between the two companies. Powered by Capital Market - Live

The facility received a Voluntary Action Indicated (VAI) classification from the USFDA, following an inspection conducted between March 20 and March 28, 2025. During the inspection, the agency issued a Form 483 with four observations. However, after reviewing the company's comprehensive response and commitments, the agency has officially closed the inspection. Neeraj Sharma, managing director & CEO, said The successful closure of our latest USFDA inspection is a pivotal moment in our journey, and we are very pleased with this outcome demonstrating our exemplary compliance status. Our flagship facility, Unit 2, is the cornerstone of our manufacturing capabilities in Drug Device Combinations (DDC), biologics drug substances, and complex injectables. This milestone validates our deep-rooted commitment to quality and is crucial as our partners prepare to launch key GLP-1 products in late FY26. We are excited to advance into our next significant commercial phase. OneSource Specialty Pharma is a pure-play specialty pharmaceutical CDMO. The company focuses on the development and manufacturing of complex pharmaceutical products including biologics, drug-device combinations, sterile injectables, and oral technologies (soft gelatine capsules). It has five manufacturing facilities approved by global regulatory authorities and a dedicated team of over 1,200 professionals. On a consolidated basis, OneSource Specialty Pharma reported net profit of Rs 98.50 crore in Q4 March 2025 as against net loss of Rs 40.17 crore in Q4 March 2024. Net sales surged 482.38% YoY to Rs 425.95 crore in Q4 March 2025. Powered by Capital Market - Live

OneSource Specialty Pharma announced that India Ratings Positive/ IND A1 for bank facilities availed by the company. Powered by Capital Market - Live

Net profit of OneSource Specialty Pharma reported to Rs 98.50 crore in the quarter ended March 2025 as against net loss of Rs 40.17 crore during the previous quarter ended March 2024. Sales rose 482.38% to Rs 425.95 crore in the quarter ended March 2025 as against Rs 73.14 crore during the previous quarter ended March 2024. For the full year,net loss reported to Rs 17.97 crore in the year ended March 2025 as against net loss of Rs 391.17 crore during the previous year ended March 2024. Sales rose 740.42% to Rs 1444.85 crore in the year ended March 2025 as against Rs 171.92 crore during the previous year ended March 2024. ParticularsQuarter EndedYear EndedMar. 2025Mar. 2024% Var.Mar. 2025Mar. 2024% Var. Sales425.9573.14 482 1444.85171.92 740 OPM %42.85-3.84 -32.29-51.33 - PBDT151.99-20.62 LP 317.67-173.46 LP PBT83.50-40.15 LP 43.78-249.76 LP NP98.50-40.17 LP -17.97-391.17 95 Powered by Capital Market - Live

OneSource Specialty Pharma will hold a meeting of the Board of Directors of the Company on 5 May 2025.Powered by Capital Market - Live

OneSource Specialty Pharma today announced that its flagship Unit 2 facility in Bengaluru has been granted Good Manufacturing Practices (GMP) certification by ANVISA, the Brazilian Health Regulatory Agency, following a successful regulatory inspection held in Nov 2024. This approval marks a significant milestone in OneSource's ongoing commitment to quality and regulatory compliance. Unit 2 is OneSource's flagship site dedicated to manufacturing high quality Biologics drug substance and finished products including Drug Device Combinations (DDC) and other injectable products.Powered by Capital Market - Live

Net Loss of OneSource Specialty Pharma reported to Rs 68.85 crore in the quarter ended December 2024 as against net loss of Rs 130.16 crore during the previous quarter ended December 2023. Sales rose 598.38% to Rs 392.56 crore in the quarter ended December 2024 as against Rs 56.21 crore during the previous quarter ended December 2023. ParticularsQuarter EndedDec. 2024Dec. 2023% Var. Sales392.5656.21 598 OPM %36.48-18.68 - PBDT102.78-35.36 LP PBT34.02-54.88 LP NP-68.85-130.16 47 Powered by Capital Market - Live