BRIDGEWATER, N.J.–(BUSINESS WIRE)–Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) today announced it has appointed Reem Malki as Senior Vice President, Chief Quality Officer, and Maryll W. Toufanian as Senior Vice President, Regulatory Strategy and Policy.
Ms. Malki brings over 30 years of quality operations and regulatory experience in the pharmaceuticals industry. She joins the Company from Alvotech, where she served as Chief Quality Officer responsible for all quality functions advancing the company’s growing biosimilar pipeline. Prior to joining Alvotech, Ms. Malki held various senior leadership roles at Mylan, including Head of Global Quality Operations. While at Mylan, she also served as VP of EMEA Quality Operations. Prior to Mylan, Ms. Malki held positions of increasing responsibility in quality control at Andrx Pharmaceuticals leading up to its acquisition by Watson Pharmaceuticals, most recently as Director of Quality Control. She began her career in the pharmaceutical industry at Wyeth Ayerst Laboratories. Ms. Malki holds a Bachelor of Science in Chemistry from the University of Maine.
Ms. Toufanian joins Amneal from the FDA’s Center for Drug Evaluation & Research (CDER) where she recently served as Director of the Office of Generic Drug Policy overseeing all regulatory and policy matters of the Office of Generic Drugs’ (OGD) generic drug program, including the development and implementation of regulations, guidance, policy statements, and publication of FDA’s Orange Book. A nationally recognized expert in drug regulation, Ms. Toufanian previously served various other senior leadership roles with the FDA, including as Deputy Director for Clinical and Regulatory Affairs (Acting) for OGD; Deputy Director, Office of Generic Drug Policy; Director, Division of Legal and Regulatory Support for OGD; Principal Advisor to the Deputy Commissioner for the FDA’s Office of Policy, Legislation and International Affairs; and as Associate Chief Counsel for Drugs for the FDA’s Office of Chief Counsel. Prior to joining the FDA, Ms. Toufanian served as an Associate with Zuckerman Spaeder LLP, specializing in food and drug and criminal defense matters. She began her legal career at Willkie Farr & Gallagher LLP, and clerked for the United States District Court for the District of Columbia. Ms. Toufanian holds a J.D. from New York University School of Law, an M.A. in English Literature from the University of Texas at Austin, and her B.A. from the University of Michigan.
Amneal Co-Chief Executive Officers Chirag Patel and Chintu Patel said, “We are so excited to welcome Reem and Maryll to our leadership team. In this next phase of growth for Amneal, we are significantly expanding in high growth areas such as biosimilars, complex generics, injectables and specialty. Reem and Maryll bring deep expertise that will be invaluable as we go forward and expand Amneal in these more complex areas.”
“Amneal has a very impressive quality track record over its twenty-year history. As the company expands into new growth areas, we will strive to maintain that industry leading quality reputation,” said Reem Malki, Senior Vice President, Chief Quality Officer. “I look forward to leveraging my biopharmaceuticals experience, particularly as Amneal grows in biosimilars.”
“I’m pleased to join the Amneal team at an exciting time in its growth trajectory. Across the company’s pipeline, I look forward to contributing my regulatory expertise to continue strengthening Amneal’s product launch and commercialization strategies. I will also ensure the company’s voice is heard on key policy issues affecting our business,” said Maryll Toufanian, Senior Vice President, Regulatory Strategy and Policy.
Amneal Pharmaceuticals, Inc. (NYSE: AMRX), headquartered in Bridgewater, NJ, is a fully integrated essential medicines company. We make healthy possible through the development, manufacturing, and distribution of generic and specialty pharmaceuticals, primarily within the United States. The Company has a diverse portfolio of over 250 products in its Generics segment and is expanding across a broad range of complex products and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceutical products 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, please visit www.amneal.com.
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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, strategies, beliefs, expectations or forecasts for the future, including among other things: product research and development; discussions of future operations; expected operating results and financial performance, including pro forma results; impact of acquisitions and dispositions, and estimated returns or assumptions underlying acquisitions and dispositions; the Company’s strategy for growth; regulatory approvals and actions; market position, saturation, and expenditures. Words such as “plans,” “expects,” “will,” “anticipates,” “estimates” and similar words 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. 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 in general, including from brand and generic drug product companies, and the impact of that competition on our ability to execute on pricing strategies; our ability to obtain exclusive marketing rights for our products; our ability to manage our growth through acquisitions and otherwise; our dependence on the sales of a limited number of products for a substantial portion of our total revenues; 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 and any associated supply chain disruptions; litigation outcomes, including intellectual property disputes or other legal efforts to prevent or curb Amneal’s ability to sell its products; the impact of severe weather; the impact of the ongoing COVID-19 pandemic; 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 product liability and other claims against us by consumers and other 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 FDA 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; the impact of global economic conditions, including any economic effects stemming from adverse geopolitical events, an economic downturn and inflation rates; our ability to identify, make and integrate acquisitions or investments in complementary businesses and products on advantageous terms; 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 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.