Shilpa Medicare Ltd

Shilpa Medicare has received approval from USFDA for Varenicline Tablets, 0.5 and 1 mg. The total US market for this product is around 203 M USD. Shilpa's product has been approved as a generic version to the innovator - Chantix Tablets, 0.5 mg and 1 mg, of PF Prism C.V. (PF Prism). Varenicline Tablets are indicated for smoking cessation; it helps people to quit smoking. Powered by Capital Market - Live

Varenicline helps people quit smoking by blocking the effect of nicotine on the brain. Nicotine is a substance found in cigarettes and other tobacco products that makes smoking feel good. Varenicline blocks this good feeling and can help prevent cravings to smoke cigarettes. The total US market for varenicline products is around $203 million. Shilpa's product has been approved as a generic version of the innovator, Chantix Tablets, 0.5 mg and 1 mg, of PF Prism C.V. (PF Prism). Shilpa Medicare is a manufacturer of API, formulation, and development services. Shilpa Medicare (SML) started its operations as an API manufacturer way back in 1987 at Raichur, Karnataka, India. The company had reported a consolidated net profit of Rs 31.78 crore in Q3 FY25, which is significantly higher as compared with the PAT of Rs 4.58 crore posted in Q3 FY24. Revenue from operations for the third quarter was at Rs 319.32 crore, up 11.35% year on year. Shares of Shilpa Medicare tumbled 3.64% to Rs 620.10 on the BSE. Powered by Capital Market - Live

BORUZU (Bortezomib for injection 3.5mg/1.4ml) is a proteasome inhibitor used for the treatment of multiple myeloma and mantle cell lymphoma. It serves as a reference to the branded product Velcade, which is a lyophilized powder that requires reconstitution before use. The pharma major stated that BORUZU (bortezomib injection) is a new presentation of bortezomib designed for ready-to-use subcutaneous or intravenous (IV) administration. This ready-to-use oncology product reduces the compounding preparation steps typically required during administration. The product has already been granted a permanent J-code by the U.S. Centers for Medicare & Medicaid Services (CMS). Vishnukant Bhutada, managing director of Shilpa Medicare, said, 'This is the second NDA product being launched in the US market from our novel injectable portfolio demonstrates our capabilities and commitment to introduce pharmacy efficient solutions that enhance compliance and have the potential to reduce patient wait times. This development exemplifies Shilpa's constant endeavor to work towards introducing novel first of its kind pharmaceutical products that help improve the healthcare requirements of a large patient pool.' Shilpa Medicare is a manufacturer of API, formulation, and development services. Shilpa Medicare (SML) started its operations as an API manufacturer way back in 1987 at Raichur, Karnataka, India. The company had reported a consolidated net profit of Rs 31.78 crore in Q3 FY25, which is significantly higher as compared with the PAT of Rs 4.58 crore posted in Q3 FY24. Revenue from operations for the third quarter was at Rs 319.32 crore, up 11.35% year on year. Powered by Capital Market - Live

Under the terms of the strategic agreement, Shilpa Biologicals will support both development, including clinical studies, as well as long-term commercial supply through GMP manufacturing. Additionally, Shilpa Group will provide mAbTree access to India and several global markets via its extensive partner network. Shilpa Biologicals will utilize its large R&D teams, providing full-service capabilities from cell line development to GMP drug product manufacturing, with manufacturing and clinical supply conducted at its state-of-the-art bio-manufacturing facility at Dharwad, Karnataka. This program aims to develop a fully human monoclonal antibody against a novel immune checkpoint protein that enables T cell activation and generation of strong immune responses against tumors akin to the well-established PD-1/PD-L1 blockade. mAbTree Biologics is a leading biotechnology company focused on the development of innovative therapies for cancer and other life-threatening diseases. With a commitment to scientific excellence and patient care, mAbTree Biologics interdisciplinary team of scientists, clinicians, and researchers aims to transform the landscape of cancer treatment through groundbreaking research and development. Madhav Bhutada, Director, Shilpa Biologicals, said, 'We are delighted to enter this strategic collaboration with mAbTree Biologics as we share a common vision to bring innovative solutions to address unmet medical needs around the globe, especially in the field of oncology, where Shilpa has had a long history of providing affordable innovative solutions.' Dr Sridevi Khambhampaty, CEO of Shilpa Biologicals, said, 'This novel therapy represents a new frontier in immuno-oncology, with the potential to expand treatment for patients who do not benefit from current immunotherapy options'so it's potentially a massive breakthrough.' Raj Andhuvan, CEO of mAbTree, added, 'mAbTree is excited to continue our strategic partnership with Shilpa Biologicals, and our aim is to enable greater access to medicines for more patients across the world, especially focusing on India and ROW markets where access has been limited, but what really impresses us about Shilpa is their commitment and scientific expertise. We look forward to rapidly advancing therapeutic options in the NBE space and to addressing emerging health challenges.' Shilpa Medicare is a manufacturer of API, formulation, and development services. Shilpa Medicare (SML) started its operations as an API manufacturer way back in 1987 at Raichur, Karnataka, India. The company had reported a consolidated net profit of Rs 31.78 crore in Q3 FY25, which is significantly higher as compared with the PAT of Rs 4.58 crore posted in Q3 FY24. Revenue from operations for the third quarter was at Rs 319.32 crore, up 11.35% year on year.Powered by Capital Market - Live

Shilpa Medicare announced that United States Food and Drugs Administration (USFDA) had conducted an inspection at Unit-2 of Shilpa Pharma Lifesciences, located at Raichur from 10 March to 14 March 2025. The inspection was closed with ZERO observations. This is second consecutive ZERO 483 inspection from USFDA at this site.Powered by Capital Market - Live

The inspection, conducted from 10 March to 14 March 2025, concluded without the issuance of any Form 483. This marks the second consecutive clean inspection at the site. Shilpa Medicare is a manufacturer of API, formulation, and development services. Shilpa Medicare (SML) started its operations as an API manufacturer way back in 1987 at Raichur, Karnataka, India. The company had reported a consolidated net profit of Rs 31.78 crore in Q3 FY25, which is significantly higher as compared with the PAT of Rs 4.58 crore posted in Q3 FY24. Revenue from operations for the third quarter was at Rs 319.32 crore, up 11.35% year on year. Shares of Shilpa Medicare tumbled 2.56% to end at Rs 628.75 on Thursday, 13 March 2025.Powered by Capital Market - Live

In a regulatory filing made after market hours yesterday, the company stated that the United States Food and Drugs Administration (USFDA) had conducted an inspection at Unit-1 of Shilpa Pharma Lifesciences, located at Raichur from March 3-7, 2025. On conclusion of inspection, we received one observation in form 483, which is procedural in nature. The company will closely work with the agency and remain committed to address this observation comprehensively within stipulated time, Shilpa Medicare stated. Shilpa Medicare is a manufacturer of API, formulation, and development services. Shilpa Medicare (SML) started its operations as an API manufacturer way back in 1987 at Raichur, Karnataka, India. The company had reported consolidated net profit of Rs 31.78 crore in Q3 FY25, which is significantly higher as compared with the PAT of Rs 4.58 crore posted in Q3 FY24. Revenue from operations for the third quarter was at Rs 319.32 crore, up 11.35% year on year. The scrip had added 1.68% to end at Rs 671.95 on the BSE yesterday. Powered by Capital Market - Live

Shilpa Medicare announces the approval of its IND - Nor Ursodeoxycholic Acid Tablets 500 mg, by the Subject Expert Committee of CDSCO. The Committee has further recommended grant of marketing authorization for this IND for the treatment of non-alcoholic fatty liver disease (NAFLD). Shilpa Medicare Ltd. had earlier completed phase-3 clinical studies of this novel product SMLNUD07 - Nor Ursodeoxycholic Acid (Nor UDCA) tablets - and presented the results of the trial titled 'A phase - III, Randomized, Double- Blind, placebo controlled, multicenter, Parallel group study' to evaluate the safety and efficacy of Nor-Ursodeoxycholic Acid 500 mg in patients suffering from Non-alcoholic Fatty Liver Disease to the SEC. This trial was a multicentric, placebo controlled double blinded study conducted on total 165 Non-alcoholic fatty liver disease (NAFLD) patients across India - a significant statistically powered number of patients leading to better reliability of data and results. No serious adverse events were reported in this phase 3 study and the treatment was well tolerated at the dose of 1500 mg per day for the duration of 24 weeks. The Phase 3 trial has met all the primary efficacy endpoints set in the clinical trial protocol, demonstrating a significant improvement in fatty liver stage. In this study 165 participants were randomised to assess and compare the efficacy and safety of nor UDCA 1500 mg against placebo. The data analysis has confirmed that liver fibrosis stage was reversed in significant majority of participants (83.3%) and stabilised in rest, within 24 weeks of nor UDCA treatment. (Primary endpoint) The elevated alanine transaminase (ALT) levels of NAFLD were normalized in significant proportion of participants (~90%) within 12 weeks of study (Primary endpoint). These results indicate that Nor UDCA could become a new standard of care with significant improvements in restoring liver function in NAFLD patients. This IND is expected to revolutionise the treatment of patients suffering from Nonalcoholic Fatty Liver Disease (NAFLD).      Powered by Capital Market - Live

Net profit of Shilpa Medicare rose 593.89% to Rs 31.78 crore in the quarter ended December 2024 as against Rs 4.58 crore during the previous quarter ended December 2023. Sales rose 11.35% to Rs 319.32 crore in the quarter ended December 2024 as against Rs 286.76 crore during the previous quarter ended December 2023. ParticularsQuarter EndedDec. 2024Dec. 2023% Var. Sales319.32286.76 11 OPM %25.2722.72 - PBDT70.4240.87 72 PBT41.6114.17 194 NP31.784.58 594 Powered by Capital Market - Live

Revenue from operations was at Rs 319.32 crore, up 11.35% year on year, driven by healthy performance in fast-growing verticals, viz. (finished dosage forms) FDF and biologics. EBITDA jumped 20% to Rs 82 crore in Q3 FY25 from Rs 68 crore registered in Q3 FY24. EBITDA margin improved to 26% in Q3 FY25 from 24% in Q3 FY24. Total expenses were up by 2.09% year on year to Rs 279.18 crore in the quarter ended 31 December 2024. The cost of materials consumed stood at Rs 89.98 crore (down 14.95% YoY), while employee benefits expense was at Rs 73.49 crore (up 6.44% YoY). On a nine-month basis, the company's consolidated net profit zoomed 765.40% to Rs 63.78 crore in 9M FY25 as compared to Rs 7.37 crore recorded in 9M FY24. Revenue from operations jumped 11.13% YoY to Rs 955.62 crore in 9M FY25. Vishnukant Bhutada, managing director of Shilpa Medicare, said, 'Our 3QFY25 performance reflects robust growth in profitability driven by an improved business mix. The quarter witnessed healthy YoY growth in our key verticals of FDF on the biologics front, we have initiated Ph3 trials for Aflibercept; and we have initiated commercial launch quantities for OLC, a US CDMO opportunity. I am also highly optimistic on receiving approval for our NCE'NorUDCA'in this financial year. With positive traction on our new product launches in the coming quarters, I am confident of delivering strong revenue growth in each business vertical. Going forward, our focus remains on scaling up API business, launching approved NDAs in regulated markets, and getting timely approvals on filed products. We continue to invest in future pipelines as well as focus on resolutions on the regulatory front. Shilpa Medicare is a manufacturer of API, formulation, and development services. Shilpa Medicare (SML) started its operations as an API manufacturer way back in 1987 at Raichur, Karnataka, India. Shares of Shilpa Medicare tanked 5.96% to currently trade at Rs 686.95 on the BSE.Powered by Capital Market - Live