Shilpa Medicare Ltd.

Boruzu is the first ready-to-use bortezomib injection for multiple myeloma and mantle cell lymphoma. Credit: SmartPhotoLab/Shutterstock. Amneal Pharmaceuticals and Shilpa Medicare have launched the new presentation of bortezomib, Boruzu, for subcutaneous or intravenous administration, offering a ready-to-use option for patients with multiple myeloma and mantle cell lymphoma in the US. Boruzu is the first ready-to-use bortezomib injection for multiple myeloma and mantle cell lymphoma , and lowers the compounding preparation process needed for administration. A proteasome inhibitor, Boruzu references branded Velcade, a lyophilised powder that needs reconstitution before usage. Shilpa has created the molecule, while Amneal will handle the manufacturing and commercialisation of the product. The most commonly reported adverse events for Boruzu in clinical studies have been anaemia, anorexia, asthenic conditions, diarrhoea, euralgia, gastrointestinal issues, leukopenia, neutropenia, peripheral neuropathy, psychiatric disorders, pyrexia, reduced appetite and thrombocytopenia. Amneal pharmaceutical biosimilars and branded oncology senior vice-president Sean McGowan stated: “As we advance our broader strategy to build a leading injectables portfolio with durable, high-impact complex products, we are excited to announce the US launch of Boruzu in our oncology portfolio. “This ready-to-use injectable marks a significant innovation for our customers by streamlining pharmacy preparation steps for clinicians while now carrying a unique J-code to facilitate reimbursement.” Amneal is a biopharmaceutical company based in Bridgewater, US. Through its affordable medicines segment, the company focuses on widening complex product categories as well as therapeutic areas, which include biosimilars and injectables. In its speciality segment, Amneal has a branded pharmaceutical portfolio focusing mainly on endocrine and central nervous system disorders. The company distributes pharmaceuticals and other products to the federal government of the US, as well as to institutional and retail markets, via its AvKARE segment. An integrated pharmaceutical group, Shilpa has business interests in peptides, oncology and non-oncology active pharmaceutical ingredients, differentiated finished dosage formulations and polymers. It also offers contract development and manufacturing organisation services to pharmaceutical firms, supported by research and development and manufacturing capabilities. In August 2024, the US Food and Drug Administration (FDA) approved Amneal’s Crexont extended-release capsules for treating Parkinson’s disease.

RAICHUR, India , March 12, 2025 /PRNewswire/ -- Shilpa Medicare Limited (BSE: 530549) (NSE: SHILPAMED), a leading API and formulation manufacturer, announces that the Subject Expert Committee (SEC) of CDSCO has approved its Investigational New Drug (IND) – Nor Ursodeoxycholic Acid (Nor UDCA) Tablets 500 mg – and recommended marketing authorization for treating non-alcoholic fatty liver disease (NAFLD). NAFLD, the most prevalent liver disease, affects approximately 25% of the global population (1.2 billion people), including 188 million in India. Left untreated, NAFLD can progress to non-alcoholic steatohepatitis (NASH), a severe and potentially fatal condition. 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. The trial met all primary efficacy endpoints, demonstrating a significant improvement in fatty liver stage. Key findings include: Liver Fibrosis Reversal: 83.3% of participants showed fibrosis reversal, with stabilization in the rest. ALT Normalization: Elevated alanine transaminase (ALT) levels, a key NAFLD marker, normalized in ~90% of participants within 12 weeks. These results position Nor UDCA as a breakthrough therapy for NAFLD, offering advantages over conventional UDCA, including enhanced choleretic effect, resistance to amidation, anti-inflammatory properties, and fibrosis reduction. Commenting on the development, Mr. Vishnukant Bhutada – Managing Director, Shilpa Medicare Limited, said, "We are very pleased with this approval from SEC and hope to get the marketing approval soon. We are committed to working closely with regulatory authorities to bring this innovative treatment to patients as quickly as possible and are hopeful of launching it in India in the coming financial year. This NCE molecule approval exemplifies the true spirit of Shilpa, 'Innovating for affordable healthcare', keeping in mind the unmet needs of a large patient pool. Based on the approval in India, we plan to reach out to Global regulatory authorities to seek scientific advice for introduction of this novel product internationally." Founded in 1987, Shilpa Medicare offers APIs, Formulations, and Biologics, with facilities approved by major regulatory agencies. The company is also recognized for providing complete turnkey CDMO solutions for clients globally. For inquiries : [email protected]. Logo: WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

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.