Latest news with #Bortezomib
Business Standard
7 days ago
- Business
- Business Standard
Medicamen Biotech rallies after securing USFDA approval for Bortezomib injection
Medicamen Biotech soared 5.39% to Rs 440 after the company has received its first Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration (USFDA) for Bortezomib for injection 3.5 mg. The ANDA pertains to Bortezomib for Injection, 3.5 mg single-dose vial. The USFDA has determined that the product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Velcade for Injection, 3.5 mg/vial, marketed by Takeda Pharmaceuticals U.S.A. Inc. (NDA-021602). This milestone marks a significant step forward in the companys strategy to enter regulated markets. The Bortezomib API was developed in-house through the companys R&D efforts and manufactured at Shivalik Rasayan, which holds USDMF 036171. The achievement underscores Medicamens capabilities in successfully developing and commercializing products using its own R&D and API manufacturing infrastructure, built over the past few years. It also highlights the companys strong commitment to stringent quality standards, robust regulatory compliance, and adherence to Current Good Manufacturing Practices (cGMP). Medicamen reaffirmed its dedication to maintaining the integrity of its products and systems as it continues to expand its footprint in the U.S. market. Medicamen Biotech is a research-led pharmaceutical company involved in developing, manufacturing, and marketing generic finished dosage formulations, and Oncology Formulations. The companys consolidated net profit rose 13.6% to Rs 2.42 crore in Q4 FY25, despite a 37.4% decline in revenue from operations to Rs 29.61 crore compared to the year-ago period.
Yahoo
01-04-2025
- Business
- Yahoo
Amneal Launches BORUZU™, First Ready-to-Use Bortezomib Injection for Multiple Myeloma and Mantle Cell Lymphoma
- First ready-to-use, subcutaneous formulation of Bortezomib now available - Marks Amneal's fourth 505(b)(2) injectable product launch in the last year BRIDGEWATER, N.J., April 01, 2025--(BUSINESS WIRE)--Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) ("Amneal" or the "Company"), a global biopharmaceutical company, and Shilpa Medicare Limited ("Shilpa") today announced the U.S. launch 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 has a unique J-code. "As we advance our broader strategy to build a leading injectables portfolio with durable, high-impact complex products, we are excited to announce the U.S. 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. Our commitment remains steadfast in delivering differentiated oncology products that enhance patient care and access," said Sean McGowan, Senior Vice President, Biosimilars and Branded Oncology. "This second NDA product being launched in the US market from our novel injectable portfolio demonstrates our capabilities and commitment to introduce pharmacy efficient solutions that enhance compliance 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. About Amneal Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in Bridgewater, NJ, is a global biopharmaceutical company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of over 280 pharmaceuticals, primarily within the United States. In its Affordable Medicines 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. 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 and follow us on LinkedIn. About Shilpa Shilpa is an integrated pharmaceutical group with business interests in niche Oncology & Non-oncology APIs, Peptides, Polymers, differentiated finished dosage formulations including novel injectables, orally dispersible films & transdermal patches along with carefully crafted biological portfolio. Shilpa also provides end-to-end CDMO services to global pharmaceutical companies across all its business segments based on its strong R&D and manufacturing capabilities backed by four R&D units and seven manufacturing facilities. For more information, please visit Cautionary Statement on 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. View source version on Contacts Investor Contact Anthony DiMeoVP, Investor Shilpa Contact Monish ShahHead Strategic & Investor Sign in to access your portfolio
