Amneal Receives First Product Approval in China

Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) today announced it has received its first product approval in China. Sevelamer carbonate was approved and is expected to launch shortly. In addition, the Company expects to launch oseltamivir phosphate in China this year as well, upon approval. In total, Amneal has 6 products pending review in China with more product registrations planned over time. Since 2019, the Company has collaborated with Fosun Pharmaceuticals to bring key therapies to market in China.

Amneal’s international expansion strategy focuses on providing access to essential medicines globally. In India, the Company is expanding its local product portfolio and utilizing its local infrastructure to commercialize directly. In Europe, China, and other countries, Amneal is collaborating with distribution partners to bring Amneal’s U.S. FDA approved product portfolio around the world. The Company has finalized distributor partnerships in over 30 countries and began the product registration process across Middle East, Africa, Latin America, and Southeast Asia regions. The Company expects international expansion will be a key vector for growth and add $50 to $100 million in revenues by 2027, and scale further over time.

“Sevelamer becomes our first product approval in China and our initial entry into the second largest pharmaceutical market in the world. With our partner, Fosun, we look forward to beginning commercialization this year. At Amneal, we are focused on advancing our internal expansion strategy to bring our portfolio of essential medicines to patients in China and around the world,” said Shyamakant Giri, President, Amneal India Business & Emerging Markets.

About Amneal

Amneal Pharmaceuticals, Inc. (NYSE: AMRX), headquartered in Bridgewater, NJ, is a fully integrated global pharmaceuticals company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of approximately 270 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.

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