Shilpa Medicare`s (SML) CDMO customer, Unicycive Therapeutics, Inc. has reported positive results from pivotal clinical trial of Oxylanthanum Carbonate (OLC), a NCE molecule with potential treatment for hyperphosphatemia in chronic kidney disease patients which has several benefits for various patients in this chronic disease. Unicycive is expected to file the New Drug Application for OLC by mid-2024 with potential approval by mid-2025. SML has partnered with Unicycive to provide end-to-end CDMO services right from development & supply of APIs to finished dosage form. Based on the outcome of the pivotal clinical studies, Unicycive has entered into long term manufacturing and supply agreement with SML and agreed to place a binding purchase order for supply of OLC tablets by 30 June  2025. Additionally, Unicycive has agreed to place orders for additional tablets to be delivered between 31 December 2025, and 30 June 2026. Apart from the supply arrangement, SML is expected to receive US$ 10 million as milestone income spanning over filing, approval and launch of the product. Additionally, in anticipation of increased product demand Unicycive will also fund the establishment of new manufacturing block at Shilpa`s site. For SML, this is a significant milestone which establishes the credentials of the Shilpa group as a one-stop reliable partner for all the CDMO requirements of global pharma companies providing development, manufacturing, supply, and other chemistry, and controls (CMC)-related services.Powered by Capital Market - Live News

Shilpa Biologicals, a wholly owned subsidiary of Shilpa Medicare has filed its first Drug Master File of recombinant Human Albumin 20% with USFDA.This novel recombinant has been developed and is a patented novel recombinant Human Albumin 20% process which is completely-Environment friendly, Consistent High-Quality product, Scalable to massive scales and is cost competitive. Recombinant Human Albumin 20% targets to fulfil growing demand of human serum albumin to deliver current and growing market demand. Powered by Capital Market - Live News

Net profit of Shilpa Medicare reported to Rs 24.50 crore in the quarter ended March 2024 as against net loss of Rs 8.04 crore during the previous quarter ended March 2023. Sales rose 10.67% to Rs 291.69 crore in the quarter ended March 2024 as against Rs 263.56 crore during the previous quarter ended March 2023.For the full year,net profit reported to Rs 31.87 crore in the year ended March 2024 as against net loss of Rs 32.53 crore during the previous year ended March 2023. Sales rose 9.66% to Rs 1151.60 crore in the year ended March 2024 as against Rs 1050.11 crore during the previous year ended March 2023. ParticularsQuarter EndedYear Ended�Mar. 2024Mar. 2023% Var.Mar. 2024Mar. 2023% Var. Sales291.69263.56 11 1151.601050.11 10 OPM %23.9714.05 -20.829.38 - PBDT48.2121.45 125 156.0857.22 173 PBT21.58-4.24 LP 48.21-38.28 LP NP24.50-8.04 LP 31.87-32.53 LP Powered by Capital Market - Live News

Shilpa Medicare will hold a meeting of the Board of Directors of the Company on 23 May 2024Powered by Capital Market - Live News

Shilpa Medicare`s marketing partner, Amneal Pharmaceuticals, has launched PEMRYDI RTU� (Pemetrexed injection 10 mg/mL), the first ready-to-use pemetrexed formulation in the US market. The product has already been granted permanent J-code (J9324) by U.S. Centers for Medicare & Medicaid Services (CMS). Pemetrexed Injection is used as a drug, in the treatment of non-small cell lung cancer in combination with other chemotherapy agents. It is also indicated in the treatment of mesothelioma in combination with cisplatin. PEMRYDI RTU� is a novel ready-to-use injection which eliminates the need for refrigeration or reconstitution and dilution for administration to the patient. This offers hospitals and oncology clinics a new, value-added presentation that should improve pharmacy efficiency by eliminating preparation steps and freeing up refrigerator space. Currently product is available in two vial sizes: 100mg/10mL and 500 mg/50mL, and we intend to introduce 1000mg/100mL soon in the market. According to IQVIA�, U.S. annual sales for pemetrexed for the 12 months ended February 2024 were $287 million.Powered by Capital Market - Live News