Propofol

BRIDGEWATER, N.J.--( BUSINESS WIRE )--Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced that it has received Abbreviated New Drug Application (“ANDA”) approval from the U.S. Food and Drug Administration (FDA) for Propofol Injectable Emulsion USP, 200 mg/20 mL (10 mg/mL), 500 mg/50 mL (10 mg/mL), and 1,000 mg/100 mL (10 mg/mL), Single-Dose Vials. Propofol is an intravenous drug commonly used in hospitals for the induction and maintenance of anesthesia and sedation. It is currently on the American Society of Health System Pharmacists (ASHP) drug shortages list. Propofol has a history of shortage due to supply chain constraints. Amneal will manufacture the product in-house on a dedicated line to provide consistent supply. “Amneal is keenly focused on delivering critical drugs that are in short supply,” said Andy Boyer, Executive Vice President, Chief Commercial Officer - Generics. “This single dose formulation of propofol is an essential medicine utilized every day by hospitals for surgical use. We are proud to provide our hospital customers with this hard-to-make product and help patients in need. With our large global manufacturing footprint, Amneal aims to be the provider of choice for complex products like propofol.” Propofol is contraindicated in people who have known hypersensitivity to propofol, egg or soybean. For full prescribing information, see package insert located here . According to IQVIA ® , U.S. annual sales for propofol for the 12 months ended June 2024 were approximately $314 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 . 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.

EDMONTON, Alberta, June 20, 2024 (GLOBE NEWSWIRE) -- Construction is set to begin on a crucial pharmaceutical manufacturing facility in the Edmonton Research Park that will provide Canadians with access to a stable supply of high-demand, critical drugs at the most difficult of times. A result of a collaboration between Applied Pharmaceutical Innovation (API) and the University of Alberta’s Li Ka Shing Applied Virology Institute, the Critical Medicines Production Centre (CMPC) is the cornerstone of the $200 million Canadian Critical Drug Initiative (CCDI) — a strategy devised in the wake of the COVID-19 pandemic to secure supply chain resilience and solidify Alberta’s and Canada’s position as a pharmaceutical leader. Officially unveiled at today’s groundbreaking ceremony, the 83,000+ square-foot facility will be unique in Canada with its ability to produce more than 70 million doses of a product a year and a critical sprint capacity to fill the needs of Canada in under 100 days. Benefits include improved patient access to needed medicines, enhanced hospital operations, and the addition of much-needed capacity to produce and manufacture therapeutic drugs here at home. One of the first products of the facility, Propofol, is a critical hospital drug. Shortages of Propofol can lead to surgery cancellations and delays. With support from all orders of government, CCDI is a significant contributor to Alberta’s burgeoning biomanufacturing and life sciences sector, creating more than 350 jobs in Alberta and notable additional employment in spin-off industries. Investment includes $80.5 million in federal funding through PrairiesCan, $17.6 million from the Government of Alberta, and City of Edmonton approval of the lease required to build the CMPC in the Edmonton Research Park. Construction for the CMPC is set to be completed by 2026. See renderings courtesy of START Architecture and CRB Consulting Engineers, Inc. here. For media inquiries, contact: Tessa VriendDirector, Engagement & Brand, API780-674-7199tessa.vriend@appliedpharma.caMichael BrownMedia Strategist, University of Alberta780-977-1411 michael.brown@ualberta.ca Quotes“The Critical Medicines Production Centre will be a game changer for the Prairies and all of Canada in producing critical, life-saving medicines. Our government is proud to partner with all levels of government, industry, and academia as we take this major step towards bringing new bio-manufacturing capacity to the province, creating high-value jobs for Albertans, and improving healthcare for everyone.” - The Honourable Dan Vandal, Minister for PrairiesCan “Alberta is a leader in life science research and technology commercialization. Our investment in API will accelerate the development of new, groundbreaking medical technologies and strengthen Alberta's healthcare system.” - Honourable Nate Glubish, Minister of Technology and Innovation, Government of Alberta "This groundbreaking marks a significant milestone for our city and region. Growing and diversifying Edmonton's economy is a priority for City Council, so we're thrilled that API and the University of Alberta are establishing the Critical Medicines Production Centre right here in the Edmonton Research Park. This project will result in strong jobs in R&D, and pharmaceutical manufacturing for Edmontonians today and in the future, and will help attract new talent to our burgeoning life sciences industry." - Councillor Keren Tang, Ward Karhiio, City of Edmonton “The Critical Medicines Production Centre will enable Alberta to produce a wide range of high-demand medicines. And it will do so much more than that – it will accelerate health innovation in the province, helping to further diversify Alberta’s economy, creating new jobs and opportunities for investment, and reducing barriers to commercialization and talent attraction.” - Aminah Robinson Fayek, Vice-President (Research and Innovation), University of Alberta “The CMPC will catalyze the expansion of the life sciences industry and fortify Canada's readiness against present and future pandemics as well as other threats that impact the global medicine supply chain. Additionally, it will drive the research and development of medications targeting prevalent diseases lacking preventive measures. Through these efforts, we aim to safeguard and enhance lives globally.” - Sir Michael Houghton, Director, Li Ka Shing Applied Virology Institute, University of Alberta and Chief Scientific Officer, Applied Pharmaceutical Innovation “Alberta can and should be a leader in discovering and manufacturing the critical medicines that will save and improve lives. The CMPC and the broader CCDI are tremendous steps forward towards building this role. This initiative will create potentially thousands of jobs in the life sciences sector, delivering substantial benefits to Canada's life sciences ecosystem by attracting investment, fostering job creation, and retaining intellectual property and talent within the country. More importantly, it will provide access to life saving treatments when we need them most.” - Andrew Maclsaac, Chief Executive Officer, Applied Pharmaceutical Innovation A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/0a643e63-d43c-417d-94f7-b2d23f209949