Shilpa Medicare Ltd.

Shilpa Medicare, a leading integrated pharmaceutical group, today announced its CDMO partner, Unicycive Therapeutics, Inc. Has successfully had the U.S. Food and Drug Administration (USFDA) accept a New Drug Application (NDA) for lanthanum oxycarbonate (OLC). This important advance marks a major breakthrough for Unicycive in the field of treating chronic kidney disease (CKD) hyperphosphatemia. The USFDA has set a Prescription Drug User Fee Act (PDUFA) target action date of June 28, 2025. If the OLC is eventually approved by the USFDA, it will be a significant boon for dialysis treated CKD hyperphosphatemia patients. Currently, these patients face an onerous treatment regimen that often requires taking up to 12 pills a day. The introduction of OLC is expected to significantly improve the treatment burden for patients as it requires a lower pill burden in terms of the number and size of pills per dose. In addition, OLC pills are designed to swallow rather than chew, increasing patient convenience and compliance. Chronic kidney disease (CKD) is a serious health condition characterized by a gradual loss of kidney function over time. The kidneys play a vital role in filtering waste and excess fluid from the blood, regulating blood pressure, balancing electrolytes, and producing hormones that affect red blood cell production and calcium metabolism. When kidney function declines, waste can build up in the body, leading to a range of serious health complications. Unicycive has entered into a long-term manufacturing contract with Shilpa, ensuring that OLC will be available on a commercial scale once approved by the U.S. Food and Drug Administration. Unicycive's NDA is currently under review and is expected to commercialize and launch an OLC in the U.S. market in the second half of 2025. Shilpa Medicare not only has a strong presence in oncology and non-oncology apis, peptides, polymers, differentiated finished dosage formulations, but also offers a wide range of formulations including oral dispersion membranes and transdermal patches. In addition, Shilpa has a well-crafted portfolio of biological products. To support its broad reach, Shilpa Medicare also provides end-to-end CDMO services to pharmaceutical companies worldwide, and its strong R&D and manufacturing capabilities are strongly supported by four R&D departments and seven manufacturing facilities.

The product is intended to treat multiple myeloma and will be launched with a unique J-code in the second quarter of next year. Credit: Nemes Laszlo/Shutterstock. The US Food and Drug Administration (FDA) has approved Amneal Pharmaceuticals and Shilpa Medicare’s oncology product BORUZU for subcutaneous administration. BORUZU, the first ready-to-use version of bortezomib, is a proteasome inhibitor indicated to treat multiple myeloma and mantle cell lymphoma. The new product simplifies the preparation process compared to the currently available lyophilised powder form, which requires reconstitution before administration. BORUZU references Velcade, the branded lyophilised powder version of bortezomib. Developed by Shilpa, BORUZU will be manufactured and commercialised by Amneal. See Also: CMN-005 by CoImmune for Extranodal Marginal Zone B-Cell Lymphoma (Mucosa-Associated Lymphoid Tissue or MALT-Lymphoma): Likelihood of Approval CMN-005 by CoImmune for Nodal Marginal Zone B-Cell Lymphoma: Likelihood of Approval The product will be launched with a unique J-code [alphanumeric codes used for non-oral medications] in the second quarter of 2025. Amneal Pharmaceuticals biosimilars and branded oncology vice-president Sean McGowan stated: “We are building a distinct branded oncology injectable portfolio. The approval of BORUZU is our fourth 505(b)(2) injectable approval this year. “These ready-to-use injectable presentations are important innovations for oncology providers as they reduce the pharmacy preparation steps for clinicians. We look forward to bringing more branded oncology products to the market for providers while expanding access for patients.” In clinical studies, the most commonly reported adverse reactions linked to BORUZU treatment were anaemia, anorexia, asthenic conditions, constipation, decreased appetite, diarrhoea, leukopenia, nausea, neuralgia, neutropenia, peripheral neuropathy, psychiatric disorders, pyrexia, thrombocytopenia and vomiting. Shilpa Medicare managing director Vishnukant Bhutada stated: “This second NDA approval in the US market from our novel injectable portfolio is a testament to our capabilities and commitment to introducing pharmacy-efficient solutions that enhance preparation and have the potential to reduce patient wait times. “This development exemplifies Shilpa’s constant endeavour to work towards introducing novel first-of-its-kind pharmaceutical products that help improve the healthcare requirements of a large patient pool.” In August 2024, the FDA approved Amneal Pharmaceuticals‘ CREXONT extended-release capsules for Parkinson’s disease treatment .

BRIDGEWATER, N.J.--( BUSINESS WIRE )--Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) and Shilpa Medicare Limited (“Shilpa”) announced U.S. Food and Drug Administration (FDA) approval of BORUZU ™ , a new presentation of bortezomib for ready-to-use subcutaneous administration or intravenous (IV) administration. This new ready-to-use oncology product reduces the compounding preparation steps typically required with administration. BORUZU (bortezomib injection), a proteasome inhibitor, is used for the treatment of multiple myeloma and mantle cell lymphoma. This product references the branded product Velcade ® , a lyophilized powder requiring reconstitution before use. Shilpa developed the molecule and Amneal will manufacture and commercialize the product. BORUZU is expected to launch with a unique J-code in the second quarter of 2025. “We are building a distinct branded oncology injectable portfolio. The approval of BORUZU is our fourth 505(b)(2) injectable approval this year. These ready-to-use injectable presentations are important innovations for oncology providers as they reduce the pharmacy preparation steps for clinicians. We look forward to bringing more branded oncology products to the market for providers while expanding access for patients,” said Sean McGowan, Vice President, Biosimilars and Branded Oncology. “This second NDA approval in the US market from our novel injectable portfolio is a testament of our capabilities and commitment to introduce pharmacy efficient solutions that enhance preparation 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,” said Vishnukant Bhutada, Managing Director of Shilpa Medicare. The most commonly reported adverse reactions for BORUZU in clinical studies include asthenic conditions, diarrhea, nausea, constipation, peripheral neuropathy, vomiting, pyrexia, thrombocytopenia, psychiatric disorders, anorexia and decreased appetite, neutropenia, neuralgia, leukopenia and anemia. For full prescribing information, see package insert located here . According to IQVIA ® , U.S. annual sales for bortezomib for the 12 months ended December 2023 were approximately $96 million. About Amneal Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in Bridgewater, NJ, is a global pharmaceuticals company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of over 280 generic and specialty pharmaceuticals, primarily within the United States. In its Generics segment, the Company is expanding across a broad range of complex product categories and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders, with a pipeline focused on unmet needs. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more information, please visit www.amneal.com . About Shilpa Shilpa Medicare is a specialized API and formulations focused pharmaceuticals company. Founded in 1987, India-based Shilpa develops, manufactures and markets active pharmaceutical ingredients (APIs) and formulations for generic medications across Oncology and other therapeutic areas. Further to consolidation in the field of oncology API and formulations, we are striving to put in our efforts in the field of novel drug delivery systems and biotech products along with widening our focus to other therapy areas. For more information, please visit www.vbshilpa.com . 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The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company’s filings with the Securities and Exchange Commission, including under Item 1A, “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and in its subsequent reports on Forms 10-Q and 8-K. Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof.