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.

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 . Forward-Looking Statements Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management’s intentions, plans, beliefs, expectations, financial results, or forecasts for the future, including among other things: discussions of future operations; expected or estimated operating results and financial performance; and statements regarding our positioning, including our ability to drive sustainable long-term growth, and other non-historical statements. Words such as “plans,” “expects,” “will,” “anticipates,” “estimates,” and similar words, or the negatives thereof, are intended to identify estimates and forward-looking statements. 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.

RAICHUR, India I August 28, 2024 I In a major breakthrough, Shilpa Medicare Limited (BSE: 530549) (NSE: SHILPAMED) proudly announces the successful completion of its Phase 1 clinical trial for its flagship product, sRbumin® – recombinant human albumin® 20% (rHA), becoming the first Indian company to achieve this milestone. The positive results underscore rHA’s potential as a viable alternative to plasma-derived human serum albumin, addressing a critical gap in global healthcare. The Phase 1 clinical study was a randomized, dose-escalating, comparative trial against European-sourced human-derived serum albumin, involving 62 healthy volunteers. It aimed to evaluate the safety, efficacy, and pharmacokinetics of rHA at different dose levels. Key Findings from the Phase 1 Clinical Trial : Human serum albumin is essential for various medical treatments, such as volume replacement therapy for accidents, burns, and surgeries. However, the current supply is heavily dependent on blood donations, leading to potential shortages. Shilpa’s rHA, produced using yeast fermentation, offers a highly purified, structurally and functionally equivalent alternative. “We are thrilled with the positive outcomes of our Phase 1 clinical trial of sRbumin® – recombinant human albumin 20%,” said Mr. Vishnukant Bhutada, Managing Director, Shilpa Medicare . “This success brings us closer to providing a safe and reliable alternative to human serum albumin, easing global supply concerns.” Shilpa Medicare is strategically positioned to expedite rHA’s development. The carefully designed clinical program, with comparisons to a proven European product, aims to streamline registration processes in Europe and emerging markets, promising a faster path to market for this critical, often-scarce product. Building on this success, Shilpa Medicare plans to initiate Phase 3 clinical trials for rHA by Q4 FY25. These trials are expected to be completed within a year, followed by product approval filings in FY26. 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. SOURCE: Shilpa Medicare