BRIDGEWATER, N.J.–(BUSINESS WIRE)–Amneal Pharmaceuticals, Inc. (NYSE: AMRX) 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.
About Amneal
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.
