The said drug is used for treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. In an exchange filing, the company said that Unicycive Therapeutics, Inc. has announced submission of NDA to USFDA for Oxylanthanum Carbonate. Unicycive has partnered with SML to provide end-to-end contract development and manufacturing organisations (CDMO) services right from development of APIs specializing in the oncology therapeutic segment and introducing novel drugs focusing on patient convenience and compliance. The company reported consolidated net profit of Rs 14.06 crore in Q1 FY25, steeply higher than Rs 1.18 crore posted in Q1 FY24. Revenue from operations grew by 12.4% year on year to Rs 292.51 crore in the quarter ended 30 June 2024. The counter hit an all time high of Rs 823.95 in today's intraday session. Powered by Capital Market - Live

Unicycive Therapeutics, Inc. (NASDAQ: UNCY) announced the submission of NDA to U.S. FDA for Oxylanthanum Carbonate for treatment of hyperphosphatemia in patients with chronic kidney disease on dialysis. The NDA submission package is based on data from three clinical studies (a Phase 1 study in healthy volunteers, a bioequivalence study in healthy volunteers, and a tolerability study of OLC in CKD patients on dialysis), multiple preclinical studies, and the specifications and practices related to chemistry, manufacturing and controls (CMC). Unicycive has partnered with Shilpa Medicare to provide end-to-end CDMO services right from development of APIs & formulation to supply of finished dosage form. Unicycive has entered into long term manufacturing and supply agreement with Shilpa Medicare for all its commercial requirements in the market starting from Q1 - FY 2025-26. Commenting on the event, Vishnukant Bhutada - Managing Director, Shilpa Medicare mentioned, 'Submission of this NDA demonstrates delivery of high quality developmental services by Shilpa to it CDMO customers and strengthens its credentials as a one-stop reliable partner for all the CDMO requirements of global pharma companies. We are very pleased to have partnered with a like-minded team of Unicycive to deliver path breaking treatments for patients suffering from chronic diseases.Powered by Capital Market - Live

The said product is the first liquid injection for Bortezomib, approved for both subcutaneous and intravenous administration by the USFDA. It is available as a single dose vial of 3.5 mg/1.4 mL (2.5 mg/mL). The injection is 'ready to use' for subcutaneous administration, offering significant advantages to the health care providers. The injection has to be diluted for intravenous use. The reference product Velcade is a lyophilized injection which requires reconstitution prior to administration. Bortezomib Injection, a proteasome inhibitor, contains bortezomib which is an antineoplastic agent. This NDA provides for the use of Bortezomib injection for the treatment of adult patients with multiple myeloma and for the treatment of adult patients with mantle cell lymphoma. Vishnukant Bhutada, managing director of Shilpa Medicare, said 'This second NDA approval in the US market from our novel injectable portfolio is a testament of our capabilities and commitment to introduce patient centric solutions that enhance compliance and ease of administration. I am very pleased to see that our relentless endeavour and self-belief of investing in various value added products across different segments have started paying off with monetization opportunities being created in each of the segments, laying a stronger foundation for the future.' Vishnukant Bhutada, managing director, Shilpa Medicare said, '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.' Raichur-based Shilpa Medicare is a vertically integrated, manufacturer and distributor of quality drugs to global markets; specializing in the oncology therapeutic segment and introducing novel drugs focusing on patient convenience and compliance. The company reported consolidated net profit of Rs 14.06 crore in Q1 FY25, steeply higher than Rs 1.18 crore posted in Q1 FY24. Revenue from operations grew by 12.4% year on year to Rs 292.51 crore in the quarter ended 30 June 2024. The counter hit an all-time high of Rs 765.00 on the BSE. Powered by Capital Market - Live

NorUDCA is expected to revolutionise the treatment of patients suffering from Nonalcoholic Fatty Liver Disease (NAFLD). Nor UDCA is likely to be a first-in-class treatment option for NAFLD in India and has significant advantages over UDCA like enhanced choleretic effect, resistance to amidation, anti-inflammatory properties and reduction in fibrosis. The company said that the trial was a multicentric, placebo controlled double blinded study conducted on total 165 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 1,500 mg per day for the duration of 24 weeks,' it added. 'The trial resulted in significant, at least one stage, decrease in liver fibrosis. Additionally, there was a significant reduction in fat accumulation in liver. The decrease in fibrosis was measured using the 'Fibroscan' technique which is the USFDA approved imaging technique for assessment of liver fibrosis. The decrease in fat accumulation was evaluated through the CAP scoring technique. Significant normalization of Alanine Aminotransferase (ALT) was conclusively demonstrated in this study. This approach provides a more holistic view of the treatment's effect by capturing multiple relevant outcomes,' the company stated in the press release. Further, Shilpa Medicare plans to submit these Phase 3 clinical trial findings at the earliest to the Central Drugs Standard Control Organisation(CDSCO), India for seeking marketing authorization in India, said the company. Vishnukant Bhutada, managing director, Shilpa Medicare said, '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.' The counter hit a 52-week high of Rs 778.20 in today's intraday session. Powered by Capital Market - Live

Shilpa Medicare has successfully completed phase-3 clinical studies of its novel product SMLNUD07 - Nor Ursodeoxycholic Acid (NorUDCA) tablets that is expected to revolutionise the treatment of patients suffering from Nonalcoholic Fatty Liver Disease (NAFLD). This trial was a multicentric, placebo controlled double blinded study conducted on total 165 Nonalcoholic 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 trial resulted in significant, at least one stage, decrease in liver fibrosis. Additionally, there was a significant reduction in fat accumulation in liver. The decrease in fibrosis was measured using the 'Fibroscan' technique which is the USFDA approved imaging technique for assessment of liver fibrosis. The decrease in fat accumulation was evaluated through the CAP scoring technique. Significant normalization of Alanine Aminotransferase (ALT) was conclusively demonstrated in this study. This approach provides a more holistic view of the treatment's effect by capturing multiple relevant outcomes. These results indicate that NorUDCA could become a new standard of care with significant improvements in restoring liver function in NAFLD patients. Shilpa Medicare Ltd plans to submit these Phase 3 clinical trial findings at the earliest to the CDSCO, India for seeking marketing authorization in India. Nor UDCA is likely to be a first-in-class treatment option for NAFLD in India and has significant advantages over UDCA like enhanced choleretic effect, resistance to amidation, anti-inflammatory properties and reduction in fibrosis.Powered by Capital Market - Live

Shilpa Medicare announced that the 37th Annual General Meeting (AGM) of the company will be held on 17 September 2024.Powered by Capital Market - Live

Net profit of Shilpa Medicare rose 1091.53% to Rs 14.06 crore in the quarter ended June 2024 as against Rs 1.18 crore during the previous quarter ended June 2023. Sales rose 12.43% to Rs 292.51 crore in the quarter ended June 2024 as against Rs 260.17 crore during the previous quarter ended June 2023. ParticularsQuarter EndedJun. 2024Jun. 2023% Var. Sales292.51260.17 12 OPM %23.9617.78 - PBDT55.7930.04 86 PBT28.683.29 772 NP14.061.18 1092 Powered by Capital Market - Live

Shilpa Medicare will hold a meeting of the Board of Directors of the Company on 8 August 2024.Powered by Capital Market - Live

Shilpa Biologicals (SBPL), a wholly owned subsidiary of Shilpa Medicare has received registration approval for Adalimumab from Morocco, MoH. This is the first Biosimilar approval from any international market for high concentration Adalimumab developed by SBPL. Shilpa Biologicals has developed high concentration adalimumab (100 mg/mL). Adalimumab contains Adalimumab as an active ingredient. Adalimumab is a fully human monoclonal IgG1 antibody produced recombinantly by Chinese Hamster Ovary (CHO)cells. Adalimumab consists of 1330 amino acid containing glycoprotein which has two copies of heavy- and two copies of light-chains in heterodimeric form with a molecular weight of 148 kDa (approx.). Adalimumab binds specifically to Tumor Necrosis Factor-alpha (TNF-') and blocks its interaction with the p55 and p75 cell surface TNF receptor. Adalimumab is indicated for Rheumatoid Arthritis (RA) in adults. The Adalimumab 40 mg/ 0.4 mL Solution for Injection is highly similar to the innovator (Humira) with respect to Quality, Safety and Efficacy. SBPL has aggressively submitted its Adalimumab dossier in more than 15 emerging markets countries and is in the process of submitting the dossier to other countries as well. Powered by Capital Market - Live

Shilpa Medicare's 100% subsidiary, Shilpa Pharma Lifesciences' Active Pharmaceutical Ingredient (API) manufacturing facility, Unit II, situated at Raichur in Karnataka state has undergone a GMP inspection by COFEPRIS-Mexico from November 6-10, 2023. Following a successful inspection, the Unit has been issued GMP Certification from COFEPRIS-MexicoPowered by Capital Market - Live