Calcium Gluconate

Bengaluru: Karnataka Health Minister Dinesh Gundu Rao has said that nine injectable drugs manufactured in other states have failed the sterility tests done in the Karnataka government's laboratories. In a letter sent to the Union Health Minister J P Nadda, he said he has instructed officials of his department to take steps to ensure that these drugs are no longer sold in Karnataka. The medicines that failed sterility tests are: Metronidazole injection manufactured by Pharma Impex Laboratories, Baruipur in West Bengal; Diclofenac Sodium Injection by Alpha Laboratories in Indore (MP); Dextrose injection by Rusoma Laboratories in Indore (MP); Metronidazole by IHL Lifesciences Private Limited in Khargone (MP); Frusemide by Paksons Pharmaceuticals at Bahadurgarh in Haryana; Piperacillin and Tazobactam by Modern Laboratories in Indore (MP); Calcium Gluconate and Ondansetron by Regain Laboratories at Hisar in Haryana; and Astropine Sulphate produced by Martin and Brown Biosciences at Solan in Himachal Pradesh, Dinesh Gundu Rao said in his letter sent on Thursday. "I am writing to bring your attention to the repeated instances of sale within Karnataka of contaminated injectable drugs manufactured in other states," Rao wrote to Nadda. Between 1 January 2025 and 16 February 2025, nine injectable drugs manufactured in other states failed 'sterility testing' in Karnataka government's laboratories, he explained. Sharing the details of the drugs along with batch numbers in his letter, Rao pointed out that the list did not include 'numerous injectables' manufactured by Paschim Banga Pharmaceuticals based in West Bengal, "whose contaminated injectables caused the deaths of five young mothers in Ballari district of Karnataka". "While I am instructing my department to take adequate steps to ensure these drugs are no longer sold within Karnataka, it is highly likely that other contaminated drugs manufactured by these companies are being sold in other states in India," the Minister said. He said injectables are used in acute care and therefore are high risk to patients. "Given the 'life or death' consequences for patients being administered these contaminated drugs, I request you to use your good offices to ensure that all products sold by these companies are withdrawn from the market across India and that these companies are not allowed to sell any more drugs until they are inspected by the Central Drugs Standard Control Organization (CDSCO) for compliance with Good Manufacturing Practices (GMP)," the Minister told Nadda. He also requested the Union Minister to create a system for all states and central laboratories to share alerts with each other regarding drugs, which have failed quality testing, especially those failures which could potentially cause serious adverse events for patients. "In addition to sharing alerts, there should also be a legal requirement to share sales records from the manufacturer to enable seizure of the contaminated drugs from the supply chain before they are dispensed to patients," Rao said. "Lastly, we need a system to alert doctors, pharmacists and patients about the drugs that are failing testing in our respective testing laboratories. My department would be glad to assist in this regard," the Minister said.>

The Company’s leading R&D capabilities and robust, expanded manufacturing capacity are helping to address chronic market shortages BRIDGEWATER, N.J.--(BUSINESS WIRE)-- Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced the continued expansion of its injectables portfolio with six new injectable product launches during the second quarter of 2024, bringing the Company’s total number of commercial injectable products available for the U.S. institutional market to over 40. The growth of Amneal’s broad injectables portfolio will help address shortages of critical products where there may be little or no clinical alternative, including in key categories such as oncology. The American Society of Health System Pharmacists (ASHP) currently lists 323 active U.S. drug shortages, with about half representing injectables. Notably, three of Amneal’s six new injectable products are currently on the ASHP drug shortage list. With these new launches, Amneal now provides 13 injectables that are on the ASHP shortage list. Amneal’s Q2 2024 injectable product launches: Product launch Dosage form ASHP drug shortage 1 PEMRYDI RTU® Vial No 2 Atropine sulfate Prefilled syringe Yes 3 Docetaxel Injection Yes 4 Foscarnet IV bag No 5 Methylprednisolone acetate Multi-dose vial Yes 6 Calcium gluconate Vial No “The persistent shortage of quality injectables is driven by multiple factors, including unstable market economics, supply chain disruptions and the need for supply redundancy. Amneal has made meaningful investments to expand our capacity and capabilities and deliver on our goal to be a significant injectables player. Importantly, we are building a robust portfolio of injectables that can serve as a reliable solution to market shortages. We are focused on being a partner our customers can count on to provide a consistent supply of high-quality medicines for their patients,” said Andy Boyer, Executive Vice President, Chief Commercial Officer – Generics. Amneal has tripled its injectables capacity to 60 million units across four manufacturing facilities over the past few years and expects to have over 60 commercial injectable products in 2025. In particular, the Company is launching branded oncology 505(b)(2) products such as PEMRYDI RTU®. These injectables are new, ready-to-use presentations that can improve pharmacy efficiency by reducing clinician steps. Amneal expects to launch two to three new 505(b)(2) injectables per year going forward. 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 pharmaceutical products, 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 . 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 reader is cautioned not to rely on these forward-looking statements. These forward-looking statements are based on current expectations of future events, including with respect to future market conditions, company performance and financial results, operational investments, business prospects, new strategies and growth initiatives, the competitive environment, and other events. If the underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of the Company. Such risks and uncertainties include, but are not limited to: our ability to successfully develop, license, acquire and commercialize new products on a timely basis; the competition we face in the pharmaceutical industry from brand and generic drug product companies, and the impact of that competition on our ability to set prices; our ability to obtain exclusive marketing rights for our products; our revenues are derived from the sales of a limited number of products, a substantial portion of which are through a limited number of customers; the impact of a prolonged business interruption within our supply chain; the continuing trend of consolidation of certain customer groups; our dependence on third-party suppliers and distributors for raw materials for our products and certain finished goods; legal, regulatory and legislative efforts by our brand competitors to deter competition from our generic alternatives; our dependence on information technology systems and infrastructure and the potential for cybersecurity incidents; our ability to attract, hire and retain highly skilled personnel; risks related to federal regulation of arrangements between manufacturers of branded and generic products; our reliance on certain licenses to proprietary technologies from time to time; the significant amount of resources we expend on research and development; the risk of claims brought against us by third parties; risks related to changes in the regulatory environment, including U.S. federal and state laws related to healthcare fraud abuse and health information privacy and security and changes in such laws; changes to Food and Drug Administration product approval requirements; the impact of healthcare reform and changes in coverage and reimbursement levels by governmental authorities and other third-party payers; our dependence on third-party agreements for a portion of our product offerings; our substantial amount of indebtedness and our ability to generate sufficient cash to service our indebtedness in the future, and the impact of interest rate fluctuations on such indebtedness; our potential expansion into additional international markets subjecting us to increased regulatory, economic, social and political uncertainties; our ability to identify, make and integrate acquisitions or investments in complementary businesses and products on advantageous terms; the impact of global economic, political or other catastrophic events; our obligations under a tax receivable agreement may be significant; and the high concentration of ownership of our Class A common stock and the fact that we are controlled by the Amneal Group. 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. Investors are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date they are made. 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 businesswire.com: Contacts Contact Anthony DiMeo VP, Investor Relations & Media anthony.dimeo@amneal.com Source: Amneal Pharmaceuticals, Inc. View this news release online at: